P03 CO-Signed PM_Part819.7007-7008_Atch1_FAR6_JA_OVER_SAT_WRJ_01-31-22.pdf

If Millennium HX RO parts and consumables are not purchased through a sole source, it would adulterate the medical device clearance, make null and void all applicable warranties, and place unnecessary risk by using non conforming components. Procuring Millennium HX RO systems, parts, consumables, and services from MAR COR \ Purification, Inc. saves you time and money by offering reliable, safe, and effective equipment and by providing single-source management and delivery, all while insuring you maintain compliance.

5. 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: There is a VA Directive mandating the use of the mandatory MAR COR SAC IDIQ. The SAC IDIQ expired 12/31/21. However, the MAR COR RO Water treatment Systems were procured under the expired IDIQ, as were the original annual maintenance services. There is a new consolidated Dialysis Contract pending approval by OPAL. MAR COR has submitted a bid. OPAL has indicated that the final award should be complete in February 2022. The 8+4 needs to be in place by 02/01/22 to ensure that there is not disruption of services.

The MAR COR Millennium HX systems are still in place. This equipment is manufactured by MAR COR. MAR COR is the OEM and the sole source service provider for the MAR COR RO Water Treatment Systems installed at VAMC WRJ. Annual PM and Servicing for this equipment is proprietary and peculiar to MAR COR. MAR COR is unique in its capability to provide the required annual/periodic servicing. A Sole Source letter was provided by MAR COR on 01 /18/22.

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

The refreshed quote provided 01/20/22 is equivalent to the pricing of the recently expired MAR COR SAC IDIQ.

The annual increase increment at 3% is also equivalent to SAC Pricing. The pricing is consistent with historical pricing and is deemed to be reasonable.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Any Other Facts Supporting the Use of Other than Full and Open Competition:

1. Market Research: Process ► VAAR 808.002 and VAAR 810.001-70: A VetBiz Search was conducted.

• There are thirty-nine (39) potentially capable SDVOS8 vendors for RO Water Treatment.

• None of the SDVOS8 vendors are authorized to service MAR COR RO Dialysis Systems.

► FAR 8.002:

•FAR 8.002(a)(1) Mandatory Sources: Mandatory Sources including AbilityOne and Federal Prison Industries (FPI) were researched and were excluded.

•FAR 8002(a)(2)(ii) Mandatory SAC IDIQ:

► FAR 8.004:

■ No data available on GSA Advantage or GSA E-Library to gather pricing data for a price analysis. Pricing was provided by MAR COR that carries SAC contract pricing from the expired SAC vehicle: 36C10G20D0038, forward through the 8+4 POP through 01/31/27.

■ VA Directive: Deputy Under Secretary for Health for Operations and Management (1 ON); Mandatory Use of Department of Veterans Affairs (references the MAR COR SAC IDIQ: 36C10G20D0038 as a Mandatory IDV Contract).

• Non-Mandatory Sources: A search of GSA Advantage indicated that there are no sources that can supply RO Dialysis Services or Reverse Osmosis Water Treatment via GSA Advantage.

• GSA FSS Contracts: There are no current GSA NAC, FSS, or MAS contracts for Reverse Osmosis Water treatment for MAR COR Purification Systems, Inc.

► VAAR 813.003-70(c): Applying VFCP to the Rule of 2

■ There are no authorized SDNOS8 distributors.

■ MAR COR will be a sole-source request to the OEM.

► VAAR 819.203-70: SDNOSB Preference:

■ This request is not eligible for VFCP.

■ Servicing of MAR COR RO Dialysis Equipment, including replacement parts for routine maintenance and disinfection services shall be sole sourced to the OEM:

MAR COR. Although the mandatory IDV:36C10G20D0038 expired 12/31/21.

The VA Directive mandates use MAR COR RO Water Treatment Systems equipment. The annual/periodic servicing and disinfection required to maintain the mandatory MAR COR RO Water treatment Systems, is peculiar to the OEM.

VHAPM Part 819.7007/7008

Original Date: 08/30/2017

Revision 03 Eff Date: 04/03/2020

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Any Other Facts Supporting the Use of Other than Full and Open Competition:

a. Market Research: Process (Cont'd) ► VAAR 819.203-70: SDNOSB Preference:

• A Sole Source Letter received 01/18/22, is specific and restricts annual servicing/disinfection to the OEM. MAR COR is unique in their capability to provide the required services.

► VAAR 852.219-10(a)(1)(v) and VAAR 852.219-10(f): NMR and LOS regulations apply to SDNOSBs and Small Businesses over SAT.

• The NMR and the LOS will not apply to the MAR COR segment for Periodic RO Water Treatment and Disinfection.

• The OEM is exclusive in their ability to service this request; the OEM has provided a Sole Source Letter.

• No SDNOSB is authorized to provide the required services, due to the existence of the Mandatory IDV held by the OEM.

► FAR 19.202-2: There are no eligible Small Business service providers.

■ Services required are peculiar and unique to the OEM: MAR COR

► NMR 13 CFR 121.406(b)

• NMR: Non-Manufacturing Rule

■ The NAICS/Description combination of 333318/ Other Commercial & Service Industry Machinery & Manufacturing is listed on the NMR Waiver List.

■ The PSC match is no longer a NMR waiver requirement.

■ No vendor in the SDNOSB or the SB socio-economic class is authorized by the OEM to service, maintain, or disinfect the MAR COR RO Water Treatment Equipment.

■ The OEM per their Sole Source Letter, per the VA Directive, and in line with NMR requirements, support procurement of the services direct from MAR COR. MAR COR.

► LOS 13 CFR 121.103

• LOS: Satisfied by a Sole Source to the OEM: MAR COR.

► FAR 6.302-1(b)(1)(i) and (4): The recommended strategy is a Sole Source Services Award to the LB OEM: MAR COR FAR 6.302-1 (b)(1)(i) and (4):

• MAR COR has provided a Sole Source Letter indicating that they are the only vendor authorized and capable of providing the required annual/periodic services and disinfection, which includes replacement of parts and filters, as required by maintenance.

• VA Directive mandates use of Mandatory MAR COR RO Water Treatment Systems.

• NMR and LOS regulations for >SAT Apply: The NMR Decision Tree identifies the only legal strategy as Large Business (LB) OEM.

• Mandatory SAC IDIQ 36C10G20D0038 expired 12/31/21.

• MAR COR has confirmed that follow-on SAQ IDIQ is in the works with OPAL and is projected to be awarded soon. OPAL has indicated that the Consolidated Dialysis contract should be awarded by the second week of February 2022.

8. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: At current, only the Large Business (LB) OEM, MAR COR has expressed interest in fulfilling this requirement. An intent to Sole Source was posted on Contract Opportunities on 01 /20/22. There have been no responses, other than MAR COR, to date.

9. 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: The VA Directive remains in place requiring that Dialysis Systems, Services, and Software be procured from mandatory, SAC IDIQ contracts. The new SAC IDIQ is pending approval by OPAL. There is no current mandatory IDIQ in place. The procurement of the MAR COR RO Water Treatment Systems were procured through the mandatory MAR COR IDV that existed at the time of procurement. The VA Directive still applies. The MAR COR products and services will be procured from the proprietary manufacturer (owner)and service provider f the MAR COR Systems, MAR COR Purification, Inc., for this service requirement.

VHAPM Part 819.7007/7008

Original Date: 08/30/2017

Revision 03 Eff Date: 04/03/2020

10. Reguirements 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.

Michael A Trombley 735381

Digitally.signed byMkhaelA Trombley 735381 Date: 2022.012712:00:43-05'00'

Michael Trombley Facilities & Services Assistant VAMC White River Junction VT

Date

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

a. Contracting Officer or Designee's Certification (reguired): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Deborah L.

Digitally signed by Deborah

L. Reardon 350203

Reardan 35Q2Q3 Date: 2022.01.2712:23:22

Deborah Reardon =us 00

Contracting Officer VAMC Bedford MA

Date

b. One Level Above the Contracting Officer (Reguired over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

VHAPM Part 819.7007/7008

Original Date: 08/30/2017

Revision 03 Eff Date: 04/03/2020

Page 4of 4

Per Tammy Fox, One level above CO not required. 01/28/22