P03 FAR6_JA_OVER_SAT - final rev signed.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 09 Page 1 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-20-AP-1289

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Veterans Health Administration Network Contracting Office 1 (New England), 623 Atwells Avenue,3rd Floor, Uncas Building, Providence, RI 02909-4799 has a requirement for the VA Boston Healthcare System, 1400 VFW Parkway West Roxbury, MA 02132. The requirement is for preventative maintenance for the Ventana Benchmark Staining Module The purchase request 2237 number is 523-20-3-7441-0070.

2. Nature and/or Description of the Action Being Processed: This is a Sole Source Firm Fixed Price contract to provide a Standard Support and Maintenance Agreement for the Ventana Symphony, HE 600 and BenchMark Ultra Staining Systems located in the Laboratory at the West Roxbury campus of the VA Boston Healthcare System. This is a new requirement for a base year with four one-year options. The estimated cost for this requirement is $32,311.08 for the base year with an aggregate total of $267,475.25.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The VA Boston Healthcare System requires a service Contract for the BenchMark XL, and ULTRA and Symphony Staining modules, for Standard Support and Maintenance for maintaining the manufacturer’s specifications for specimen diagnostics. These Tissue Stainers are required to be maintained at manufacture’s specifications for Patient Diagnostics when tissue is removed surgically. These specifications are required by JCAHO, CAP, and VA regulations. Standard terms and conditions for services packages apply. The service is for the BenchMark Ultra serial numbers 311199, 316131, and for the Ventana HE600 serial number 6000677. The period of performance is as follows:

Base Year (6/1/2020-5/31/2021) Option Year 1 (6/1/2021-5/31/2022) Option Year 2 (6/1/2022-5/31/2023) Option Year 3 (6/1/2023-5/31/2024) Option Year 4 (6/1/2024-5/31/2025)

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 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

OFOC SOP Revision 09 Page 2 of 4

Revision 09 Date: 04/17/2020

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) – Only ROCHE Diagnostics, the LB Original Equipment Manufacturer and licensed owner of the highly specialized Ventana Medical Systems located at the VA Boston Healthcare System, is capable of providing the equipment and the proprietary software in the proper operating condition as well as providing the proper updates to the software for equipment already installed. ROCHE Diagnostics is the original equipment manufacturer and uniquely qualified to provide timely support on this critical system and solely possesses support personnel to maintain this highly expensive and sensitive piece of medical equipment to the OEM Specifications. Accordingly, ROCHE Diagnostics is the only vendor capable of providing the supplies and services for the Ventana Symphony, and BenchMark XL and ULTRA Stainers without incurring substantial risk of contamination of tissue specimens. The Ventana Medical System(s) is Roche-owned, the service must be performed by Roche Diagnostics service employees or the service contract for these instruments will be rendered null and void. The proprietary nature of the technology contained within the instrument requires that only Roche Diagnostics perform certain maintenance and service procedures. The operator’s manual describes the routine maintenance activities that should be performed by end users. All other activities must be performed by Roche Diagnostics service employees.

Accordingly, Roche Diagnostic Corporation is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements. Failure to fulfill the VHA requirements would cause great hardship upon the facility due to the delay in treatment, diagnosis and monitoring of our Veteran population.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VA Boston Healthcare System acquired the Ventana Stainer equipment several years ago. In order to fully maintain this system to the Original Equipment Manufacturer standards and the standards established in the healthcare industry. VA Boston Healthcare System is in need of annual support and service to maintain these standards. As with any piece of medical equipment to include the peripheral parts, pieces and supporting software it is still a matter of proprietary rights by the original equipment manufacturer whether the equipment is covered under warranty or not.

As such in order for this request to become more competitive the Department of Veterans Affairs and the VA Boston Healthcare System would have to accept more risk.

A Sources Sought was issued on April 16, 2020 under 36C24120Q0301 for preventive maintenance on the BenchMark Ultra Staining Module to gain market knowledge of potential Service-Disabled Veteran, Veteran Owned Business or other small business sources and their size classifications. The Performance Work Statement describing the requirement was attached. No response was received from the industry for this requirement.

A search was also conducted in VIP- Vendor Information Pages to determine if any SDVOSB’s/VOSB’s were available and capable to fill this requirement. The search was conducted using NAICS code 811219 with the PSC J066. Key words Ventana Benchmark Stainer

OFOC SOP Revision 09 Page 3 of 4

Revision 09 Date: 04/17/2020 was also used. The results showed no SDVOSBs or VOSBs available. A search was also conducted on the SBA website using the NAICS code 811219 with keywords Ventana Benchmark Stainer and no profiles matched the search criteria. SAMs, FPDS, and GSA were also used to find other similar contracts for this requirement with no results.

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

Reasonable: The vendor is providing a quote to the VA for a base year plus 4 option years to include three pieces of equipment with a grand total of $267,475.25. The previous contract in place VA241- 15-C-0018 was also for a base plus 4 years for three pieces of equipment with a grand total of $384,617.04. This is a 43.8 percent decrease from the current contract. Therefore, the contracting officer finds the anticipated cost 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: A search was conducted in VIP- Vendor Information Pages to determine if any SDVOSB’s/VOSB’s were available and capable to fill this requirement. The search was conducted using NAICS code 811219 with the PSC J066. Key words Ventana Benchmark Stainer was also used. The results showed no SDVOSBs or VOSBs available. A search was also conducted on the SBA website using the NAICS code 811219 with keywords Ventana Benchmark Stainer and no profiles matched the search criteria. SAMs, FPDS, and GSA were also used to find other similar contracts for this requirement with no results. A Sources Sought was issued on April 16, 2020 with no response from the industry for this requirement. We received a letter on 11/17/2019 from Roche Diagnostics Corporation that in North America Ventana Medical Systems is the sole manufacturer and its affiliate Roche Diagnostics Corporation is the distributor for all Ventana instrumentation (i.e. Benchmark systems) and required reagents / ancillaries. Roche owns the Ventana Medical Systems and the technology is proprietary. The service must be performed by Roche Diagnostics service employees or the service contract for this instrument is rendered null and void. As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The need for these services to be contracted with Roche are due to the possible issues that could arise. The service must be performed by Roche Diagnostics service employees or the service contract for this instrument is rendered null and void. If the service contract for this highly technical medical equipment were null and void the services may lapse. The lapse could cause significant delays in providing the necessary diagnostic and treatment of patients from the Veteran population serviced by the VA Boston Healthcare System.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No sources expressed an interest in this requirement.

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:

Boston Clinical Engineering department is currently reviewing the various stations clinical engineering requirements and consistently bringing equipment up to date. They are also investigating the possibility of clinical technicians assuming many requirements. This would be more beneficial and cost effective across the VISN.

OFOC SOP Revision 09 Page 4 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

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.

05/13/2020 Date

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.

_____________________________ 05/13/2020 Ann Marie Stewart Date Contracting Officer

Network Contracting Office 1

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.

_____________________________ 05/13/2020 Victor E. Martin Date Branch Chief

Network Contracting Office 1