36C77018Q0361-003.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 3 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Full and Open Competition Brand Name

Acquisition Plan Action ID: 765-18-2-021-0427

1. Contracting Activity: Department of Veterans Affairs, VISN 15, Department of Veteran Affairs, Great Lakes – Hines, IL CMOP Acquisitions.

2. Nature and/or Description of the Action Being Processed: The procurement of open market Med- Surg. and Mini-med items for the dispensing of prescriptions at the Great Lakes, Hines, IL CMOP. The brand name specific items are standardized by the VA, and a generic or other item is not approved for dispensing. Any other item would compromise VA standardized patient care, as it would contradict physician’s orders.

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

FAR13.5 Simplified Procedures for Certain Commercial Items listed below:

99010018100 1 SET,INFUSION ANIMAS #181-00 CMOP

ID#XV242 NDC-99010018100 IMF-7766

00078052030 2 EYELID CLEANSER,EYE SCRUB PAD CMOP

ID#E0301 NDC-00078052030 IMF#3876

76212300204 3 BAG,LEG CONVEEN #5170 CMOP ID#XX251

NDC-76212300204 IMF#1073

99900090110 4 BAG,URINARY DRAINAGE L1 #UDB901 CMOP

ID#XH671 NDC-99900090110 IMF#12767

76845510571 5 POUCH,DRAINABLE,SUR-FIT C#4113-10

CMOP ID#XV347 NDC-76845510571

57074000161 6 KERASAL NAIL TOP LIQUID CMOP

ID#K0064 NDC-57074000161

08627005104 7 GLUCOSE SENSOR DEXCOM G4-G5 CMOP

ID#XI431 NDC-08627005104

76300033210 8 RESERVOIR,MINIMED #MMT-332A CMOP

ID#XZ835 NDC-76300033210 IMF#487

08380011204 9 BARRIER,OSTOMY,NEW IMAGE H#11204

CMOP ID#XI279 NDC-08380011204

OFOC SOP Revision 06 Page 2 of 3

Revision 06 Date: 08/30/2017

99010018400 10 SET,INFUSION ANIMAS #184-00 CMOP

ID#XV275 NDC-99010018400 IMF#7768

65781001246 11 CARTRIDGE,ANIMAS IR 2ML 1200

#100-124-01 CMOP ID#XU057

NDC-65781001246 IMF#2041

76300087610 12 SET,INFUSION MINIMED #MMT-876 CMOP

ID#XT587 NDC-76300087610

00121067616 13 CITRIC ACID 334/POTASSIUM CIT

1100MG/5ML CMOP ID#C1360

NDC-00121067616

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;

( ) (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):

Veteran patients have had specific medications and med-surg. items prescribed by physician, and they are the only item with can be used. This is the only brand and specific NDC’s listed in the description that will meet the Government’s need without experiencing unacceptable delays in fulfilling its requirements and possibly endangering patient care.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An unrestricted open market solicitation for quotes will be used for this requirement utilizing the Brand Name Specific) descriptions.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Based on determination of historical purchases, and market research, the potential sources provide cost to the government that has been deemed 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 (In Vitro Diagnostic Substance Manufacturing) Despite these results, there are no known SDVOSB, VOSB, HUBZone, 8(a), or small business organizations that manufacture the

OFOC SOP Revision 06 Page 3 of 3

Revision 06 Date: 08/30/2017 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. Due to these time frames, I am not afforded the time for the process of requesting an individual waiver.

9. 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.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No Offers where received.

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:

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.

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.

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

a. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

John C. Fisher Supervisory Contracting Officer, Level III NCO15 CMOP Acquisitions http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx