P03 JOFOC 36C260-22-AP-4015 Zeiss EHRM - HCA Approved.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

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

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C260-22-AP-4015

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional

Procurement Office West, Network Contracting Office (NCO) 20 on behalf of Veterans Integrated Services Network (VISN) 20 Various Medical Centers. 2237: 101-22-3-5281-0214.

2. Nature and/or Description of the Action Being Processed: This is a justification for a brand-name firm-fixed price procurement for new Zeiss Optical equipment that will be replacing and supplementing equipment in support of the VA EHRM Cerner initiatives for ten VISN 20 centers.

Many of the devices are running on an unsupported operating system leaving the system open to security vulnerabilities. This equipment is necessary to properly meet the needs of the hospital workflow.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a commercial 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: All image acquisition components, archive components, and viewing components provided by the contractor must work seamlessly with the Zeiss FORUM database system that is currently installed at the medical centers within VISN 20. See table for the equipment and licensing requirements:

Equipment/License Qty

Cirrus 5000 w/AngioPlex OCT 6

Cirrus HD-OCT 5000 1

Clarus 500 4

IOL Master 700 computer OS upgrade 1

HFA3 860 8

Matrix 800 1

SL 800 1

Zeiss Forum 3rd Party Instrument License 7

Zeiss Instrument License+ Design 15

IOL Master 700 1

Atlas 500 1

The total estimated value of the requirement is $1,397,478.08 (includes Trade-ins)

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented

Effective Date: 02/01/2022 Page 2 of 3 by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirement

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This is a brand-name justification in support of FAR 11.105, Items Peculiar to One Manufacturer. VISN 20 Eye Clinic imaging modalities require an upgrade as some of the current Zeiss devices are operating on an unsupported operating system. Upgrading these devices is critical to ensure seamless integration of VA EHRM Cerner. Since these devices are proprietary to Zeiss and must be compatible with Zeiss FORUM database system that is currently installed at the medical centers within VISN 20, no other vendor can provide. It would be cost prohibitive and greatly impact patient care to replace all VISN 20 Medical Centers optical equipment and supporting software with another vendor’s solution. As such, the equipment requested is manufacturered by Carl Zeiss Meditech. Zeiss provided a proprietary letter which outlines only Zeiss can provide service and upgrades to equipment and any software integratations with Zess FORUM are not authorized. This acquisition is essential to the Government’s requirements, thereby precluding consideration of a product manufactured by another company.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A limited search for sources was conducted as Zeiss is the only manufacturer/ brand that can meet the Government’s requirement. Zeiss was contacted to find out if they had any small business partners, they provided the following sources: Proaim (small) and Corps Biolodics

(SDVOSB).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government will be considered fair and reasonable based on competition.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research IAW FAR Part 10 to validate only one manufacturer can integrate with Zeiss FORUM software. Zeiss provided a proprietary letter which outlines only Zeiss can provide service and upgrades to equipment and any software integratations with Zess FORUM are not authorized. The original purchases of the Zeiss equipment and FORUM database were competed. Zeiss does have small business providers for their equipment and software: ProAIM (Small) and Corps Biologics (SDVOSB).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No further action is planned. This is an equipment refresh for implementing EHRM, to upgrade equipment to align with supported operating systems, and to standardize equipment. Using standardized medical equipment and ensuring this equipment operates on a supported operating system, which is properly patched to bolster system securities, are bona fide clinical need for patient safety.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: ProAim (Small) and Corps Biologics (SDVOSB).

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

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:

Future changes in available technologies or standards will require review and approval from the facility Clinical Products Review Committee (CPRC). However, market research will continue to be completed for all subsequent acquisitions to ensure to promote competition from authorized sources.

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.

Cheryl Shaw V20 Biomedical Engineer/COR

VISN 20

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.

Robert Hamilton Contracting Officer Network Contracting Office 20 (NCO 20)

RPO West JOFOC Tracker#: 2022-08-28T15:41:43

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

S. Dale Allen Director of Contracting Network Contracting Office 20 (NCO 20)

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 approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx