P03 PG_Part806.3_Atch1_FAR6_JA_OVER_SAT tmk signed CD.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 4

Revision: 03 Effective Date: 04/15/24

Acquisition ID#: __________________

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA-24-00035794_____

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 1, located at White River Junction, VT, in support of VISN 01, VA Health Care System at White River

Junction Medical Center 2237 # 405-24-2-2008-0017

2. Nature and/or Description of the Action Being Processed:

This requirement is to procure a laser to individually tag all RMD equipment in the facility, scanners to upload necessary data in the OR and Clinic areas, laser training so that the facility will have qualified operators, a team to come out and start tagging the instruments and speed up the process, and a service contract for up to 1 year. This laser system from NuTrace is the only laser that is acceptable and has been tested and in use in other VA hospitals in VISN 1.

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

NuTrace Fiber Laser 1064nm 20W accomplishes one of the most important tasks following the FDA UDI rule (Unique Device Identification) which is the marking and retrofitting of each instrument inside the hospital's supply chain with a 2D Data Matrix code. This barcode is universal (It can be GS1 as well) and can be read by any barcode reader, as well by any tracking system available in the market. This is a tremendous task to perform, not only because the limit availability of the sets, but because the time needed for marking is extremely short, where every mark must be applied perfectly in an extremely short time. The VA requires efficiency and safety for their patients, this is why they are using the NuTrace

NUX-20 laser surgical instrument laser marker at other VA medical centers, they have had a NuTrace for a few years now and it works great. This laser even etches rounded items (dental/podiatry), there is a configuration for the 2D data Matrix barcode (8x20) that makes the mark into a rectangle which the scanners have a higher percentage of reading as opposed to the normal square 2d Data Matrix. Please note that the 2D Data Matrix is not the same format as a QR code, which gives us greater versatility when trying to fit a scannable barcode onto an oddly shaped instrument.

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR

6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

VHAPG Part 806.3 OFOC Page 2 of 4

Acquisition ID#: __________________

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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 specific laser allows the Department of Veteran Affairs to etch plastic and round items, which would help etch most medical instruments that we can’t currently etch. This laser provides permanent etches, that will not fade or be removed over time. The VA’s current chemical etcher provides etches that fade over time and is currently not acceptable.

The Nutrace laser consists of:

• NuTrace NUX-20 laser unit. 20W Max power

• NuTrace R+ 2D DataMatrix reader for code verification

• NuTrace Computer/Laptop with Windows 10 and supporting accessories

• Fumex Fume/Odor extractor equipment. FA1-M

• NuTrace Select & Mark templates. Different laser configurations for different instrument materials included GS1 Codes

• NuTrace Select Set of Assorted Vectors to identify surgical instruments

• 2 hours of laser safety awareness guidance online by LIA (Laser Institute of America). Two seats.

-10 hours of training on site included

• 2 pairs of 1064nm OD7+ "Clear View" safety glasses to operate the laser in class 4 mode

• Instructional videos and manuals

At this time, no other laser can meet the required characteristics as specified above. Furthermore the required laser has been purchased by other VISN 1 locations and in order to continue continuity amongst existing VA systems, this requirement must be a brand name only requirement. The Contract Specialists plans to utilize VAAR 819.7006 VA service-disabled veteran-owned small business set-aside procedures as the rule of two can be met.

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

The Contract Specialist was able to locate two SDVOSB authorized distributors of the required items. As such, the rule of two is met and the Contract Specialist can solicit the requirement as 100% SDVOSB set-aside.

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

Reasonable:

The Contract Specialist expected to determine the proposed price as fair and reasonable in accordance with adequate price competition, FAR 13.106-3(a)(1).

VHAPG Part 806.3 OFOC Page 3 of 4

Acquisition ID#: __________________

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

Reasons Market Research Was Not Conducted:

Two SDVOSBs were located, no further market research needs as the Rule of Two is met in accordance with VAAR 819.7006 VA service-disabled veteran-owned small business set-aside procedures.

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

None

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

None

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:

Market research will be conducted upon every additional requirement. The Contract Specialist will assess current market conditions and suppliers at that time and act accordingly.

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.

Lead Technician Date

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

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

Contracting Officer Date

4/22/2024 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

VHAPG Part 806.3 OFOC Page 4 of 4

Acquisition ID#: __________________

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.

Branch Chief Date