P03 Optos JA signed.pdf

36C245-22-AP-1540 / 482-22-4-648-0013 / Optos Units

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C245-22-AP-1540

1. Contracting Activity: Department of Veterans Affairs, VISN 5 Medical Centers, Eye Clinic; 2237: 482-

22-4-648-0013

2. Nature and/or Description of the Action Being Approved: The mission of the eye clinic of the VA

Medical Centers located in VISN 5 is to provide eye care for its veteran population. VISN 5 has a need for Optos Silverstone devices to perform imaging of the back surface of the eye of patients, which is imperative in the management of several diseases, including diabetes, retinal tear or detachment, retinal dystrophy, cancer, and others. The Optos devices are manufactured by Optos, Inc. Service-Disabled Veteran Owned Business (SDVOSB) Melling LLC has been identified as the sole authorized distributor of the supply.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The contractor will provide Optos Silverstone SS OCT Ultrawide-Field Imaging Devices, DICOM Modality Worklist (MWL) and Live Store to Third Party PACS installation, calibration & on-site training. This device uses lasers to record the fundus of the eye, as well as to perform autofluorescence, which reveals different disease states and acquires optical tomograms of anatomic concerns.

The contractor will coordinate with the Veterans Affairs Medical Center department of biomedical engineering, to service all on-site installation of hardware and software, as well as to provide any on-going support within the frame of their warranty-period.

The estimated price is $186,340.01 per device and $1,118,040.06 for the total contract price. The estimated delivery date is 9/2/2022.

This device is to be used on-site, in the eye clinic of each VISN Medical Center in VISN 5:

VA Maryland Healthcare System – Baltimore VA Maryland Healthcare System – Perry Point Beckley VA Medical Center Clarksburg VA Medical Center Martinsburg VA Medical Center Washington DC VA Medical Center

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

(x) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): The Contracting Officer has determined that –

Effective Date: 02/01/2022 Page 2 of 3

(1) The anticipated award price of the contract is $1,118,040.06 (no options required) and will not exceed $5 million.

(2) Synopsizing the justification is not applicable in accordance with FAR part 5.

(3) The SDVOSB concern has been determined to be a responsible source with respect to performance.

(4) In the estimation of the contracting officer, contract award can be made at a fair and reasonable price that offers best value to the Government (see paragraph 7 below).

(5) The use of this authority is judicious and in the best interest of the Government.

(6) The SDVOSB source meets eligibility requirements in VAAR 819.7003 as the source is eligible.

under this subpart, NAICS code matches the one assigned in this acquisition, and verification is current in VIP database (www.vip.vetbiz.gov).

By meeting all six (6) requirements, sole sourcing this requirement to a verified SDVOSB is applicable and meets the requirement of VAAR 819.707.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies: RFI 36C24522Q0420 was posted on 3/16/2022 on sam.gov. Only one vendor responded – Melling LLC. FPDS & GSA were also searched.

No alternatives were found.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The price was determined reasonable based on the Independent Government Cost Estimate. In addition, a similar contract was found on FPDS. Contract 36C24521P0630 was awarded to vendor Melling LLC. The award date was 8/26/21. The price was $372,680.02 ($184,787.51 per unit).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: RFI 36C24522Q0420 was posted on 3/16/2022 on sam.gov.

Only one vendor responded – Melling LLC. FPDS & GSA were also searched. No alternatives were found. Additionally, Melling LLC provided a letter from the manufacturer (Optos, LLC) stating that Melling LLC is the sole authorized distributor of the supply.

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: Melling LLC

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: If this supply is needed by the VA in future procurements, thorough market research will be conducted to ensure any barriers to competition will be removed or overcome before making subsequent acquisitions.

https://www.acquisition.gov/content/part-5-publicizing-contract-actions

Effective Date: 02/01/2022 Page 3 of 3

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.

Angela Mulinix Date V5 Biomedical Engineer VISN 05 Capitol Health Care Network

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.

Ryan Singletary Date Contracting Officer

NCO 5

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Allison Lewis Date Branch Chief Commodities Team 1

NCO 5

c. VHA RPO 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 for other than full and open competition.

Joseph P. Maletta Date

Executive Director Regional Procurement Office - East https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx