Siemens J and A redacted.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C263-20-AP-4005

1. Contracting Activity: US Department of Veterans Affairs, NC023, 4801 Veterans Drive, St. Cloud, Minnesota. Ordering Activity: US Department of Veterans Affairs, St. Cloud VA Health Care System (VAHCS), 4801 Veterans Drive, St. Cloud, MN 56303-2099.

2237 No. 656-21-2-043-0002

2. Nature and/or Description of the Action Being Processed: This is a new firm-fixed-price contract for a mobile Computed Tomography Imaging Services (CT) trailer to be located at the St. Cloud VAHCS. This is a brand name justification for the 'Siemens Perspective 64 slice with Windows 10 Operating System' mobile CT scanner to be competed amongst Small Business (SB) firms.

FAR 13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a lease of a mobile CT trailer for the St. Cloud VAHCS 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 6.302-2.

3. Descrintion of SuDplies/Services Required to Meet the Agency's Needs: The St. Cloud VAHCS is requiring a CT trailer until the new Diagnostic Imaging Center is.built at the St. Cloud VA facility.

Until construction is complete, a mobile CT unit will be needed so care of the Veterans can continue.

The Contractor shall provide installation, equipment, hook up, including venting, training, maintenance and service (repair) of all Contractor furnished equipment (including a mobile trailer/unit) necessary to perform mobile Computed Tomography Imaging Services at the St. Cloud VAHCS. The Contractor is to provide a Siemens Perspective 64 slice with Windows 10 Operating System Mobile CT scanner for CT exams for Veterans at the St. Cloud VA facility. The CT scanner is to be in a modular trailer which will be parked at the facility until the completion of the separate construction project. The Contractor will provide the mobile unit, but VA staff will operate the equipment daily.

Mobile Trailer: Mobile trailer where studies will be performed on equipment furnished by the Contractor. The entire offering of the CT mobile trailer service shall meet all local, state, federal, industry, Joint Commission NEC, NFPA, VA, OSHA, and other regulatory standards internal or external applicable to the St. Cloud VAHCS. The CT trailer shall provide space enough for conducting CPR and code, if needed. The mobile trailer shall also have an intercom system between the control room and scanning room and CD-R burning capabilities as a backup to network transfer of data. The patient data is the property of the St. Cloud VAHCS. The mobile CT trailer shall maintain a temperature to assure proper operation of the scanner without frequent calibration and provide for

OFOC SOP Revision 10 Page 1 of 5 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

VHAPM Part 806.3Other Than Full and Open Competition (OFOC) SOP patient comfort. The mobile trailer shall have a lift system for patients who require a wheelchair or stretcher. The lift system shall include railings for fall safety.

Mobile CT Specifications:

Mobile CT general configuration that is consistent with Siemens Perspective 64 slice Mobile CT scanner

¯ Windows 10 Operating System ¯ Full compatibility with hospital PACS system DICOM 3.0 ¯ Bayer/Medrad Stellate contrast injector with certegra workstation.

should be serviced by the OEM-Bayer!Medrad ¯ Shall have 360 Degree rotation 0.5 seconds ¯ Minimum number of samples per rotation (images, slices) > 64 ¯ Display and record CTDlvol (dose) after exposure ¯ Automated milliamps (ma) regulation ¯ Adaptive iterative reconstruction ¯ Contrast timed injections to include bolus activated injection ¯ HL7 integration (HlS/RIS) ¯ DICOM and IHE-Q/R, MWM, STORAGE COMMIT SCU, MPPS

The contrast injector

¯ NEMAXR 29 compliant ¯ FDA 510 K compliant ¯ OEM approved to put in a trailer, provide documentation ¯ Technical requirements of the table shall include full articulation of table, patient weight capacity of >200kg or 440 lbs

Period of Performance: Nine months beginning 01/01/2021 with four (4) 12-month option periods and one (1) three month option period for a total of 60 months.

Base Period:

Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Option Period 5:

01/01/21-09/30/21 10/1/21 - 09/30/22 10/01/22 - 09/30/23 10/01/23 - 09/30/24 10/01/24 - 09/30/25 10/01/25 - 12/31/25

4. Statutory Authority Permitting Other than Full and Open Competition: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 U.S.C.

§3304(a)(1) as implemented by FAR 6.302-1.

FAR 13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. §1901 and is implemented by 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): A requirement of the

OFOC SOP Revision 10 Page 2 of 5 procurement is to have a mobile unit that utilizes Siemens Perspective 64 slice CT Scanner with Windows 10 Operating System. This is the same equipment the. St. Cloud VAHCS currently uses. It is configured to work with existing systems, so the produced images are in the same format, and same quality. Staff are trained on the system, so no additional training is needed. Additional training could potentially add three to six months delaying patient care. Using the same system also provides continuity of care to the Veteran.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice was posted to beta.SAM to gauge interest and identify potential vendors. Four vendors responed in writing to the posting and the incumbent contacted the Contracting Officer verbally. The Sources Sought notice was posted on 09/10/2020 on beta.SAM, with responses due NLT COB on 09/17/2020. The three small businesses that replied in writing provided capability statements that appear to demonstrate the ability to meet our requirement. The fourth small business that contacted me verbally is the incumbent and has been providing satisfactory performance overthe past several years. A presolicitation notice and the subsequent RFQ will be posted competitively via beta.SAM to generate the maximum competition possible.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: As this procurement will be competed amongst small businesses, there is an expectation of fair and reasonable pricing based on competition.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Government's technical experts conducted market research by reviewing other similar mobile CT units. This market research is an ongoing process.

Based on reviews of these products, the Government's technical experts determined that none of these other products/CT scanners can meet the Government's interoperability and compatibility requirements previously discussed. Additionally, VA's technical experts regularly review industry trade publications and conduct internet research to ascertain if any other brand name software is available. Based on all of these market research efforts, the Government's technical experts have determined that only Siemens Perspective 64 slice CT Scanner with Windows 10 Operating System, will meet all of VA's needs. A VIP search using NAICS 532490, Other Commercial and Industrial Machinery and Equipment Rental and Leasing, yielded 143 matches. Market research has demonstrated that there are sufficient small business interest in providing this brand name only procurement.

During market research the requestor looked for any previous or current contracts, searched GSA, the SBA website, Google, SEWP and searched via the internet. The requestor reached out to potential vendors. A Request for Information (RFI)/Sources Sought notice was posted to beta.SAM which elicited four written inquiries and one verbal contact regarding this procurement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The required CT platform is needed to provide clearer, consistent images for Veterans. The St. Cloud VA inhouse CT scanner is the same make/model. Use of a different CT scanner would lead to inconsistent or variation in images and interpretations, which leads to bad medical outcomes for Veterans. The needed software packages also provide for faster scans. The staff have many years of experience

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VHAPM Part 8063 Other Than Full and Open Competition (OFOC) SOP using this equipment which leads to quick, accurate testing for the Veterans; changing equipment during this time would create delays and patient access issues.

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

Shared Medical Services, 209 Limestone Pass, Cottage Grove WI, 53257 (Large)

Medical Equipment Solutions, 2298 Coral Way, Miami FL 33145 (8a/EDWOSB)

A&B Technical LLC, 794 Barkley Crest Circle, Auburn AL 36830-21709 (SDVOSB)

Mosaic Health LLC, 150 SE 2 Ave Ste 300, Miami FL 33131 (WOSB)

NOTE: The incumbent, a small business (Interim Diagnostic Imaging) contacted the Government via phone to express their interest in this posting.

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: As there is a reasonable expectation of receiving quotes from three or more small businesses, this procurement will be set aside for small businesses. The Rule of Two was not met; therefore, this requirement will not be set aside for SDVOSB/VOSB. The Request for Quote will be posted on the beta.SAM contract opportunities website to solicit responses from other small businesses that can provide this mobile CT trailer.

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.

St. Cloud VAHCS

OFOC SOP Revision 10 Page 4 of5

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

a. Contracting Officer or Designee's Certification: I certify that the foregoing justification is

- accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer: I certify the justification meets requirements for other than full and open competition.

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

OFOC SOP Revision 10 Page 5 of 5

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