36C77019Q0025-002.doc

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:____761-19-1-014-0001__

1. Contracting Activity:

Department of Veterans Affairs

Network 15 Contracting Office (NCO15)

3450 South 13th Street

Leavenworth, KS 66048

Items are to be delivered to the Chelmsford, MA CMOP

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

The Chelmsford CMOP, 10 Industrial Ave., Chelmsford, MA 01824, Consolidated Mail Outpatient Pharmacy is requesting approval to purchase the Brand name only per Physicians determination of need for the several med/Surge products as described below. This is a new procurement and will be a firm fixed price contract. The total estimated value for this request is $501,147.94 The list below does include all drug items included in this request.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a variety of Medical Surgical items 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 6.303-2.

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

O0346 - ONE TOUCH VERIO (GLUCOSE) TEST STRIP

· NDC – 53885027210

· Quantity of request: 600

· 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.

The estimated Purchase Order value is for this request for this item is $60,000.00

XH019 - LANCET,ACCU-CHEK FASTCLIX DRUM

· NDC/PART# 65702028810

· Quantity of Request: 192

· 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

· Designed to reduce the pain of blood glucose testing

· Proven least painful and overall easiest to use

· Package contains 102 Roche lancets

The estimated Purchase Order value is for this request for this item is $2572.80

XH509 – GLUCOSE SENSOR ENLITE MMT-7008

· NDC/PART# MMT-7008A

· QUANTITY OF REQEST: 288

· SUPPLIER: MEDTRONIC

Enlite Sensor

Enlite™ Glucose Sensors have an electrode inserted just under the skin and measure glucose values which are relayed to the pump and CGM monitor. Enlite combines improved performance and is designed for comfort and ease of use.

Please note: The Enlite Sensor must be combined with the Guardian 2 Link transmitter/MiniLink transmitter to wirelessly transmit glucose readings to the MiniMed 640G/VEO insulin pump. You must complete a Continuous Glucose Monitoring (CGM) start with your healthcare professional team before using this product. Be sure to discuss questions specific to your health and treatments with a healthcare professional.

One button insertion process Up to 6 days use Indicated for Children and Adults

The estimated Purchase Order value is for this request for this item is $120672.00

XJ430 - GLUCOSE SENSOR (3) GUARDIAN MMT-7020A

· NDC/PART# - MMT-7020(A)

· Quantity of Request: 288

· SUPPLIER: MEDTRONIC

The Guardian Sensor (3) is intended for use with the Medtronic MiniMed® 670G system to continuously monitor glucose levels in persons with diabetes. It is intended to be used for detecting trends and tracking patterns in persons aged fourteen years and older, and to be used by the MiniMed 670G system to automatically adjust basal insulin levels. It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. The Guardian Sensor (3) is indicated for 7 days of continuous use.

The estimated Purchase Order value is for this request for this item is $120672.00

XH709 - CATH SET,INTERM 12FR C#28422

· NDC -99050728422 (NO SUBSTITUTES)

· Quantity of request: 240

· 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

The estimated Purchase Order value is for this request for this item is $20167.20

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

The estimated Purchase Order value is for this request for this item is $3840.00

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

· NDC/PART# HOLLISTER #71144

· Quantity of request: 240

· 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

· The estimated Purchase Order value is for this request for this item is $34296.00

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

· NDC/PART# BD 326730 (08290-3267-30)

· Quantity of request: 48

· 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 The estimated Purchase Order value is for this request for this item is $1465.44

XT104 - BAG,URINARY DRAINAGE MERIT #FZ624

· NDC/PART# 97909000624/FZ624

· Quantity of request: 240

· SUPPLIER: MERIT

Merit Medical Systems Drainage Depot Bag with Soft Cloth backing, 600mL, Large Bore Tubing, Twist Drain Valve Drainage Depot, 600 ml bag. Comes with easy to use twist valve empty port, Velcro strap, adjustable tubing and soft cloth back for extra patient comfort

The estimated Purchase Order value is for this request for this item is: $3648.00

XT868 - SET,INFUSION MINIMED #MMT-387

· NDC/PART# 70524406515/MMT-387

· Quantity of request: 120

· 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.

The estimated Purchase Order value is for this request for this item is $11880.00

XV066 - CATH SET, INTERMIT 14FR H#96144

· NDC/PART# 5096144

· Quantity of Request: 600

· 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.

· The estimated Purchase Order value is for this request for this item is $65400.00

XV077 – PLEURX DRAINAGE KIT D#50-7500

· NDC/PART# - 99950750010/50-7500B

· QUANTITY of REQUEST – 800

· SUPPLIER – CAREFUSION – POSSIBLY NOW BD?

PleurX drainage kit 50-7500B (500 mL) and 50-7510 (1,000 mL)

The PleurX drainage kit includes a procedure pack that provides the components needed each time the patient drains fluid.

Each drainage kit (50-7500B and 50-7510) contains:

• Plastic vacuum bottle with attached drainage line

Procedure pack components

• Blue wrapping

• Alcohol pads (qty. 3)

• Pair of gloves

• Valve cap

• Blue emergency slide clamp

• Gauze pads, 4" x 4" (10.2 cm x 10.2 cm, [qty. 4])

• Foam catheter pad

• Self-adhesive dressing

· The estimated Purchase Order value is for this request for this item is $42880.00

XZ835 - RESERVOIR,MINIMED #MMT-332A

· NDC/PART# 43169786554/ MMT-332A

· Quantity of request: 480

· SUPPLIER: MEDRONIC

Medtronic MiniMed Paradigm Reservoir is intended for use with the MiniMed Paradigm™ 71x insulin pumps and infusion sets only. It is custom made for Medtronic MiniMed Paradigm™ 7 Series insulin pumps and can be used with all Medtronic MiniMed Paradigm™ infusion sets. User-filled reservoir holds up to 3ml of insulin Reservoir Size: 3.0 ml – MMT332A About MiniMed Paradigm 71x insulin Pumps: Can be hidden and worn under clothing for daily use. It is small and water resistant. Ref #: MMT-332A

The estimated Purchase Order value is for this request for this item is $13200.00

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 FAR 6.302-1;

(x ) (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;

FAR13.5 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 for 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):

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.

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

Products were searched in the NAC and GSA catalog and none of the items were found to be on contract.

7. 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 Fair and Reasonable.

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

Market research was conducted through Vet Biz and DSBS under NAICS 325413. Because the Government is not allowed to do business using Wholesale Trade or Retail Trade NAICS codes, searches must be conducted using the manufacturer NAICS code 325413 Despite these results, there are no known SDVOSB, VOSB, or small business organizations that manufacture the items required for this procurement. Due to the SBA NMR, as defined in FAR Part 19 and 13 Code of Federal Regulations (CFR) 121.406, an SDVOSB/VOSB/SB set aside of any kind is not feasible as there is no waiver of the Non-Manufacturer Rule from the SBA over the SAT for NAICS code 325413. A request for an individual NMR waiver will take approximately 15 business days to process IAW https://www.sba.gov/contracting/contracting-officials/non-manufacturer-rule/non-manufacturer-waivers. CMOPs are required to fill a prescription within 5 days or the prescription must be returned to the Medical Center for filling. Due to these time frames, I am not afforded the time for the process of requesting an individual waiver and thus delaying critical Veteran patient care. Therefore, based on this research, it is determined this requirement must be solicited as an Unrestricted Procurement (Full and Open Competition), to be posted atwww.fbo.gov.

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

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

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:

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.

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.

____10-3-2018____________________

Name: Joseph Sousa Date

Title IMS Facility 761 NE CMOP

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.

Name: Frank Tarara Date

Title Contract Specialist Facility

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

Name Date

NCO/15

Facility

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018