-17123.pdf

OFOC SOP Revision 08 Page 1 of 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-19-AP-1745

Contracting Activity: Department of Veterans Affairs, VISN 02, James J Peters VAMC, Research Service/Veterinary Medical Unit, Bronx, NY thru 2237#526-19-2-1918-0260 to purchase Brand Name Only Tecniplast seal safe racks and cages on a non-competitive acquisition.

Nature and/or Description of the Action Being Processed: This request is for approval to purchase as brand name only Tecniplast USA, (Tecniplast) ventilated racks and cages for rats and mice as a small business sole source, fixed price award. The VMU houses laboratory animals in accordance with all applicable Federal, State and VA regulations and the requirements of AAALAC.

The VMU has moved to housing animals in ventilated cage racks, which provide numerous advantages for animal welfare including better control of temperature and humidity, a design that isolates animals from their surroundings to reduce the chance that animals will be infected by bacteria, parasites or fungi. In addition, ventilated caging allows higher numbers of cages per room and reduced numbers of cage changes to increase efficiency of operation.

Given these restrictive parameters, the features provided by the Tecniplast system made them the ideal choice to use to standardize the caging in the lab. Consequently, any new cages must also be Tecniplast to maintain the conformity within the lab conditions and insure the integrity of the research that is being done utilizing this equipment.

Total estimated Value $

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

The JJP VAMC animal facility is already outfitted with Tecniplast ventilated racks. No other cages will work with Tecniplast racks. It is also crucial to maintain consistency in the lab by outfitting it with the same equipment. Any change in rack, cage or air handler type increases the risk of operational error and puts animals’ lives at greater risk.

Here are the Tecniplast systems JJP VAMC intends to purchase:

Seal safe Plus DGM Rack, single sided Includes the following components:

80 cage bodies GM500SU, 80 tops GM500TOPSEALSU, 80 wire lids

Seal safe plus DGM Rack, single sided Includes the following components:

70 cage bodies GM500SU, 70 tops GM500TOPSEALSU, 70 wire lids GM500LID

Seal safe Plus DGM Rack, double sided

OFOC SOP Revision 08 Page 2 of 5

Revision 08 Date: 04/18/2018

Includes the following components:

160 cage bodies GM500SU, 160 tops GM500TOPSEALSU, 160 wire lids GM500LID

Seal safe Plus Rat Rack, sized for 28 cages, single sided Complete with cage bodies, wire lids and filter tops

Seal safe Plus Rat Rack, sized for 35 cages, single sided Complete with cage bodies, wire lids and filter tops

Seal safe Plus Rat Rack sized 70 cages, double sided Complete with cage bodies, wire lids and filter tops

Smart Flow” air handling unit, 110V-60HZ, Fahr. Degrees, US plug

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 FAR 6.302-1;

() (2) Unusual and Compelling Urgency per FAR 6.302-2;

() (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

() (4) International Agreement per FAR 6.302-4 () (5) Authorized or Required by Statute FAR 6.302-5;

() (6) National Security per FAR 6.302-6;

() (7) Public Interest per 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):

Tecniplast has been determined to be the only one responsible source to meet the Government’s requirements. The JJP VAMC animal facility is already outfitted with Tecniplast ventilated racks. No other cages will work with Tecniplast racks. The Tecniplast brand is essential to the Government’s requirement, thereby precluding consideration of a product manufactured by another company.

Accordingly, Tecniplast-products are the only products capable of providing the supplies as described in Section 3 above without the Veterans Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through utilization of another manufacturer and unacceptable delays in fulfilling its requirement.

Tecniplast cage racks as described above are currently being used by the Bronx VMU. The brand and model of cage racks, caging, and accessories need to be consistent throughout the facility for The following reason:

Maintain smooth cage change-out and cleaning operations.

Consistency for researchers: The number of variables affecting the animals need to be kept to a minimum to maintain the integrity of research experiments. Change in caging

OFOC SOP Revision 08 Page 3 of 5

Revision 08 Date: 04/18/2018

Consistency in caging/rack system: Consistency in caging/rack system within the VMU is important to maintain efficient workflow. Changing cage systems requires re-training of

VMU employees and time-consuming updates to current SOP’s (Standard Operating Practices). Staff will require as much as six months to work at full efficiency with minimal errors. A change in rack and cages type increases the risk of operational errors during the training period, putting animals’ lives at risk.

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

Special Notice - Intent to Sole Source” (36C24219Q0408) was posted on FBO for 7 days, closing on 3/7/2019 at 4:00 PM. One response was received by (an SDVOSB) who is a reseller of Tecniplast products.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The quoted price by Tecniplast is consistent with their listed pricing, and historical pricing for VISN 2.

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

The result of the VIP search on the NAICS code (33 999) and keyword “Tecniplast” turned up zero results

The result of the DSBS search on the NAICS code (33 999) and keyword “Tecniplast” turned up zero results

The result of the DSBS search for the specific business “Tecniplast” determined that TECNIPLAST USA, INC is a Small business manufacturer in NAICS code 33 999 with CAGE code 3W3D2.

Special Notice – Intent to Sole Source” (36C24219Q0408) was posted on FBO for 7 days, closing on 03/7/2019 at 4:00PM. One response was received by (an SDVOSB) who is an authorized reseller of the Tecniplast products.

Another SDVOSB was determined to have been a reseller of Tecniplast products at least once in the past year to another VISN, but they did not respond to the notice.

Tecniplast confirmed to the CO that both are authorized resellers of their products.

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

This is an urgent requirement and the turnaround time in getting these new cages installed could be as much as 14 weeks from date of award. So, it is critical to award as soon as possible. The demand for housing laboratory animals has grown substantially over the past few years and now exceeds our current supply of ventilated caging. To meet this increased demand, VISN 2 applied for funds to purchase additional Tecniplast ventilated cage racks and cages via the laboratory Animal Major Equipment program, and the approved funding is an acknowledgement as to the importance and urgency of procuring these additional caging systems ASAP.

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

Tecniplast (a SB Manufacturer) (an SDVOSB) who is a reseller of Tecniplast products.

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 action can be taken due to the proprietary nature of this sole source.

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.

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

Date

PMO/R&D

JJP VAMC