P03-JA_FOR_MODIFICATION.pdf

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

OFOC SOP Revision 08 Page 1 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C245-18-AP-0516

1. Contracting Activity: Department of Veterans Affairs, VISN 05, Baltimore VA Medical Center

For Surgical Care- Ophthalmology POC Michelle Bland. Purchase request #512-18-3-042-0429

2. Nature and/or Description of the Action Being Processed: The VA Maryland Health Care System requests a modification to the Purchase Order, 512-A80249, procurement of an ophthalmic surgical microscope. Following award of the current microscope, one of the using physicians identified some components that were missing from the original quote. Since the device will be used for retinal surgery, retina and OCT attachments are required for high quality images of the posterior segment of the eye. There is also a need for a tilting function, which is used by glaucoma specialist for visualization of the angled structures during glaucoma surgery. These two modifications are necessary for a fully functional unit for specialty surgery. This is a revisition to the original Justificaiton and Approval for other than full and open compeitition, needed because only the Carl Zeiss Medtec product was capable of meeting the VA’s needs.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The use of a surgical microscope has substantially affected the practice of ophthalmology by reducing the amount of invasiveness required, reducing recovery time and fundamentally allowing improved care. OPMI LUMERA 700 is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures for both the anterior segment of the eye (e.g. cataract, cornea, glaucoma) and, when used in combination with the RESIGHT® non-contact fundus viewing system, the posterior segment of the eye (retina, vitreous). The modification results in an increase to the original purchase order in the magnitude of $118,393.97 for a total of $314,986. Fiscal has identified the funding required for the increase and confirmed we have the funds.

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;

OFOC SOP Revision 08 Page 2 of 3

Revision 08 Date: 04/18/2018

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 Only One Responsible Source (FAR 6.302-1 Carl Zeiss Meditec, Inc. products are authorized to be sold through the preferred Small Dis-advantaged Owned government distributor PROAIM America’s LLC. Select features and specifications are unique to the OPMI LUMERA 700 surgical microscopy platform. The use of a surgical microscope has substantially affected the practice of ophthalmology by reducing the amount of invasiveness required, reducing recovery time and fundamentally allowing improved care. OPMI LUMERA 700 is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures for both the anterior segment of the eye (e.g. cataract, cornea, glaucoma) and, when used in combination with the RESIGHT® non-contact fundus viewing system, the posterior segment of the eye (retina, vitreous). A unique ZEISS offering, CALLISTO eye is a system that receives biometry and keratometry information from the ZEISS IOLMaster® biometer and uses it to project overlays into the eyepieces of the OPMI LUMERA® family of surgical microscopes in a heads-up-display-like fashion. These overlays increase the accuracy and precision of incision placement, the tearing of the capsulorhexis as well as the centration and alignment of IOLs during a cataract surgical procedure.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Contacted OEM and was provided a sole source letter.

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

The cost is considered fair and reasonable.

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

Market Research Was Not Conducted:

FAR 6.302-1, As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by contacting the OEM and asking for authorized sellers of the product.

Only one is authorized.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: none

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Proaim America’s LLC

10. 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: NO reasonable action can be taken by the government to change the available of the market place.

OFOC SOP Revision 08 Page 3 of 3

Revision 08 Date: 04/18/2018

11. 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.

Zachary Smith Date

Chief, Biomedical Engineering Service

12. 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.

Bradley Davis Date Contracting Offier NCO 5

VHABALSmithZ Typewritten Text 1.14.2019