36C24620A0008-001.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36(246-19-AP

1. Contracting Activity: Department of Vetera ns Affai rs, VISN 06, Durham VA Medical Center NCO 06/ RPO East PR# 558-20-1-044-0011.

2. Nature and/or Description of the Action Being Processed: Th is is a new requ irement for consumables for the Vitros 3600.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is fo r consumables for the Vitros 3600 system in accordance with FAR 13.5 Simpl ified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Docum entation Requ irements, 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: Th is procurement is for the following consumables for the Vit ros 3600:

25 EA: ECi A-HBC 100 w ells US 25 EA: ECi A-HBS IGM 52 wells 44 EA: ECi A-H BS QUANT 100 wells US 105 EA: Eci A-HCV 100 wells US 34 EA: Eci HBSAG 100 well s US 24 EA: HAVTotal 10 EA: HAV lgm

Total cost for the entire procurement including options wi ll be $759,784.20. The per iod of performance will be from October 1, 2019, to September 30, 2024.

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 Requi rements per FAR 6.302-1;

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

( ) (3) Industrial Mobilizat ion, Engineering, Developmenta l or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) Intern ational 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) Publ ic Interest per FAR 6.302-7;

FAR13 .5 Sim lified Procedures for Certain Commercial Items: The authority fo r applying the Si mplif ied Procedures fo r Commercia l Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restr icting competition on th is procurement via FAR 13.106-1(b)(2).

OFOC SOP Revision 08 Origi nal Date: 03/22/ 11 Revision 08 Date : 04/18/ 2018

5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Vitros 3600 is a proprietary system of Johnson & Johnson. This is a highly specialized system that P&LMS and Microbiology section uses to perform Hepatitis A and B t esting and Hepatitis C screenings for Durham, Greenville, and Morehead CBOC's and Hepatitis C screening for the Asheville VA. The Vitros system is also the only system that does not require the implementation of a water system . Which will help the VA conserve water and protect the environment and employees from any waste.

Any change in the system at this point would require retra ining for both the medical st aff and the bioengineer section which would cost the Government in unacceptable delays to direct patient care.

The Government would also incur substantial duplication cost 's due to changing the entire system that is currently in use at Durham, Greenville, Morehead, and Asheville . Both the delays and cost of changing systems are not expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought was issued on August 2nd

, 2019 and closed August 9th , 2019.

The sources sought deta iled the products that are being requested, along w ith the location of place of performance, period of performance, and the system that the consumables were being used for.

The only 2 sources that responded to the sources sought was the manufacturer and AM Scientific Supply. AM Scientific Supply indicated on August 9th that they were looking into if they could provide products in sources sought. As of August 26th

, 2019 they have not sent a follow up indicating they will be able to provide the product requested in the sources sought.

Other searches that were conducted to facilitate competition were searches to the procurement history on FPDS. The CS had gone back 4 years and all procurements have been made through the manufacturer' s FSS schedule. GSA elibrary was searched using key Vitros under SIN 66 Ill and only the manufacturer populated in the search . GSA Advantage was also sea rched and only the manufacturer was found to be able to provide products requested . NAC MedSurg and FBO were also searched and no vendors were found to be able to provide the products the Government is requesting.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CS anticipates the cost will be fair and reasonable because item is on FSS and according to FAR 8.404 (d) "GSA has already determined the prices of suppl ies .. . to be fair and reasonable. "

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Per VA's Vet erans First Contractracting Program the CS has exhausted all avenues in trying to find Veteran Owned businesses by searching VIP and sending out correspondence to all SDVOSBs and VOSBs under th e NAICS code325413. All respondents that sent correspondence back indicated that they were a no-bid .

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by a synopsis of the proposed acquisition, advisi ng industry of the pend ing acquisition and solicit ing inquiries from interested pa rties. It has been determined that only one respons ible source to be able to meet the Governm ents need and past procurement history is in line with this determination.

OFOC SOP Revision 08 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Product is specific to a highly specialized system. Th is system is the proprietary technology of Johnson & Johnson.

10. listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Ortho Clinical Diagnostics - OBA Johnson & Johnson and AM Scientific Supply.

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 : At this time no actions are planned to overcome any barriers to competition as the Vitros 3600 is specialized technology that meets the needs of the Veterans Affairs Med ical Centers.

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.

Digltalty signed by KERRIE L

KERRIE L. LARISA 234965 LARISA 234965

Date: 2019.09.12 07:39:40 •04'00'

Kerrie Larisa Supervisory Technologist P&LMS Durham VAMC

Date

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

a. Contract Specialist & Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and bel ief.

Digitally signed by Isaac Isaac Hernandez- Hernandez-Cosme 1545875

Cosme 1545875

Isaac Hernandez

Date: 2019.09.11 16:02:31 -04'00'

NCO/PCO 06 Contract Specialist Fayetteville VAMC

JAMES W.

Digitally signed by JAMES

W. BROWN 5391 SB

BROWN 539158 Date:2019.09.1208:05:18 -04'00'

James Brown NCO/PCO 06 Contracting Officer Fayetteville VAMC

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.

KEESHIA R

NEWMAN

254911

Digitally <signed by

KEESHIA R NEWMAN

254911 Date: 2019.09.12 08:28:30-04'00'

Keeshia Newman Date NCO 06/RPO East Branch Chief - Supervisor Hampton VAMC

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.

OFOC SOP Revision 08 Original Date: 03/22/11 Revision 08 Date : 04/18/2018

OFOC SOP Revision 08 Original Date: 03/22/11 Revision 08 Date : 04/18/2018

Date