36C77018Q0188-002.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K

OFOC SOP Revision 06 Page 1 of 6 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID:___VA770-18-AP-0200

1. Contracting Activity: Consolidated Mail Outpatient Pharmacy Leavenworth, KS the Department of Veterans Affairs Network 15 Contracting Office (NCO), 3450 S. 4th St Trafficway, Leavenworth, KS 66048 is the contracting agency. Supplies will be purchased for the CMOP Chelmsford location at 10 Industrial Avenue Chelmsford, MA 01824-3610.

761-18-1-014-0085

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

FAR13.5 Simplified Procedures for Certain Commercial Items:

O0346 - ONE TOUCH VERIO (GLUCOSE) TEST STRIP

NDC – 53885027210

Quantity of request: 240

Supplier: LIFESCAN The OneTouch Verio® test strips provide accuracy your patients can rely on.

Requiring only 0.4 µL of blood, our test strips have achieved 5 years of proven clinical accuracy even at extremely low and high blood glucose levels. For blood glucose testing with the OneTouch Verio® family of meters, including the OneTouch Verio Flex® meter, OneTouch Verio® meter, and OneTouch Verio IQ® meter.

XH019 - LANCET,ACCU-CHEK FASTCLIX DRUM

NDC/PART# 65702028810

Quantity of Request: 480

SUPPLIER – ROCHE

These special strips are designed to work with all models of Accu-Chek FastClix, the only one-click lancing system available with a drum. Accu-Chek lancets draw blood quickly and effectively for neat and easy application onto test strips. Each package comes with 102 lancets. Accu-Chek FastClix devices and test strips are sold separately.

Accu-Chek FastClix Lancets:

For all models of Accu-Chek FastClix Accu-Check FastClix devices are sold separately The only 1-click lancing system with a drum

OFOC SOP Revision 06 Page 2 of 6

Revision 06 Date: 08/30/2017

Designed to reduce the pain of blood glucose testing Proven least painful and overall easiest to use Package contains 102 Roche lancets

XH709 - CATH SET,INTERM 12FR C#28422

NDC -99050728422 (NO SUBSTITUTES)

Quantity of request: 864

Supplier: COLOPLAST

Less than half the size of a standard male catheter, SpeediCath Compact Male can be stored, carried, used and disposed of more discreetly. It can be inserted without touching the coated section. It comes ready to use – for even greater convenience and discretion.

All-in-one catheter and bag set that is instantly ready to use

Small enough to keep in a pocket or handbag.

The only compact and discreet catheter with an integrated and sterile bag

XI079 - INSULIN SYRINGE 0.5ML 31G 6MM

NDC/PART# 08290324911/324911

Quantity of request: 120

SUPPLIER: BD

The NEW BD Insulin Syringe with the BD Ultra-Fine™ 6mm needle is effective as longer needles, are less intimidating, and reduces the risk of a painful injection in the muscle

XI429 - CATH,INTERMITTENT VAPRO PLUS 14F H#71144

NDC/PART# HOLLISTER #71144

Quantity of request: 300

Supplier: HOLLISTER

Easy-to-carry package fits easily into a pocket or backpack

Protective tip helps shield the sterile catheter from bacteria located within the initial 15 mm of the distal urethra

Protective sleeve allows the catheter to be gripped anywhere along the length of the catheter

Ready-to-use hydrophilic catheter with pure catheter hydration technology. Designed to be evenly lubricated for easy insertion

Large finger hole with tear strip helps facilitate easy opening Smooth eyelets help ease of insertion and withdrawal Ring cap helps keep protective tip clean and protected until use Available in both 16" (40 cm) and 8" (20 cm) lengths Not made with natural rubber latex, phthalates-free PVC material

OFOC SOP Revision 06 Page 3 of 6

Revision 06 Date: 08/30/2017

XI743 - INSULIN SYRINGE 0.5ML 31G 6MM (U-500)

NDC/PART# BD 326730 (08290-3267-30)

Quantity of request: 144

Supplier: COLOPLAST

Dose conversion is no longer needed when using this syringe with Humulin R U-500 vials

The U-500 insulin syringe draws to and doses the insulin units prescribed Only the U-500 insulin syringe should be used with the U-500 vial

XT868 - SET,INFUSION MINIMED #MMT-387

NDC/PART# 70524406515/MMT-387

Quantity of request: 300

SUPPLIER : MEDTRONIC

The Medtronic Minimed Quick-set® infusion conveniently disconnects at the infusion site and offers a pre-attached adhesive for a discreet, low profile design. The Medtronic Minimed Quick-set® Infusion Set (MMT397) offers a 9mm soft cannula and 23 inch tubing for mostly everyone. The Safe Needle Disposal System of the Medtronic Minimed Quick-set helps prevent accidental sticking when disposing of the introducer needle in your sharps container. This Medtronic Minimed set works with the Quick-serter to provide optimal insertion every time.

XV066 - CATH SET, INTERMIT 14FR H#96144

NDC/PART# 5096144

Quantity of Request: 480

SUPPLIER – HOLLISTER

Ready-to-use, pre-lubricated, single-use closed system intermittent catheter.

Latex-Free.

Unique protective tip.

No-Touch insertion technique.

User-regulated gel reservoir.

2 Smooth catheter eyelets.

Color-coded funnel.

1500mL collection pouch.

XV391 - CATHETER, FOLEY 16FR 5CC BARD #123516A

NDC/PART# 123516A

QTY of Request: 84

SUPPLIER: BARD

A Foley Catheter, also called Indwelling, is a long term use catheter. It may remain in place nearly a month, though it must be checked for cleanliness. Recommended indications include

OFOC SOP Revision 06 Page 4 of 6

Revision 06 Date: 08/30/2017 urinary obstructions, Neurogenic Bladders, surgeries, terminal patients, spinal cord or pelvic injuries. A Foley Catheter can be 2 or 3 way.

2. 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;

3. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Brand Specific” products are the same thing as “dispense as written” on a physician prescription. No NDC substitutions are permitted. In the VA, Pharmacy

Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify “brand specific” products in the VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

4. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This will be released on FBO.GOV as an urestricted item

5. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: : The IGCE contains the estimated cost to the government and serves as the recognition of F&R

6. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Products were searched in the NAC and GSA catalog and none of the items were found to be on contract.

7. Any Other Facts Supporting the Use of Other than Full and Open Competition: Due to physician prescribed devices, the need to compete for this brand name specific item will result in Veterans receiving the appropriate items for the prescribed use.

8. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No previous offers were received. Only the mandatory source contract supplies the specialized item. Pleurx Drainage Kits D# 50-7510 for peritoneal fluid drainage for Veterans with severe wound care

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: There were no actions taken to remove or overcome barriers as these are brand name specific items prescribed by a physician and no generic or other item will meet the needs of the government.

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Revision 06 Date: 08/30/2017

9. 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.

________Not Needed_____________________ Diana Walters Date Title Inventory Mgt Supervisor Facility VA CMOP Chelmsford

1. 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.

Name Lori Nichols Fellows Date Title Contracting Officer Facility NCO 15 (CMOP)

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Name James Justus Date Supervisor (CMOP)

NCO 15 (CMOP)

c. VHA SAO 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 recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

__________________Not Needed___________

Name Date VHA Head of Contracting Activity (HCA) http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

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Revision 06 Date: 08/30/2017

d. VHA Senior Procurement Executive Approval (over $68 million): 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.

_________________Not Needed____________

Jan R. Frye Date Deputy Assistant Secretary for Acquisition and Logistics Senior Procurement Executive (SPE) Department of Veterans Affairs