36C25618C0073-001.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For Other Than Full and Open Competition

Acquisition Plan Action ID:

Contracting Activity: Department of Veterans Affairs, Network Contracting Office 16, Michael E DeBakey VA Medical Center (MEDVAMC). Clinical Support Service Line has provided this Justification and Approval for Other Than Full and Open Competition for the procurement for the preventative maintenance for the Medrad Injectors Service Contract.

Purchase Request number 580-18-2-255-0468.

Nature and/or Description of the Action Being Processed: Request a new firm fixed priced contract for Sole Source procurement to Novamed Corporation, for service for Medrad Injectors Service Contract. Located in Bldg. 100 for a period of performance 1, 2018 to 3 , 2019. Plus four 12 Month Option Periods.

Description of Supplies/Services Required to Meet the Agency’s Needs: The preventative services are required to maintain the equipment in a functioning state to allow its use in the MEDVAMC. The original equipment manufacturer is Bayer, and have established an agreement with Novamed a Small Business to provide preventive maintenance and support services to meet the agency need. Any delay in maintenance of this Medrad Injector System would mostly likely result in cancelled procedures. Scope of repair is beyond expertise of any in-house staff.

Estimated Value: $411,752.25

Quantity Unit of Issue

3 EA

7 EA

1 EA

3 EA

5 EA

Base Year: $82,350.45 Option Year 1: $82,350.45 Option Year 2: $82,350.45 Option Year 3: $82,350.45 Option Year 4: $82,350.45

Description Medrad Mark Arterion Angiography Injection Sys Medrad Avanta Fluid Mgmt Injection Sys Medrad Mark V ProVis Angiography Injection Sys Medrad Stellant D CT Injection Sys Medrad Spectris Solaris EP MR Injection Sys

EA

Estimated delivery dates: 0 -01-2018

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR Part 13.5 – Simplified Procedures for Certain Commercial Items

(a) Sole source (including brand name) acquisitions. (1) Acquisitions conducted under simplified acquisition procedures are exempt from the requirements in part 6.

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Novamed Corporation possesses a maintenance agreement with the original manufacturer to service government equipment. No other contractor or vendor has proprietary rights or provided evidence from OEM supporting their capability to provide the required services. These unit injectors are critical for patient care, it is used to diagnose abnormalities during radiological or MR imaging. The device must operate in tight tolearance to deliver contrast injection at the right time and at the right dose. Contrast media can be harmful to patients in quantities above the minimum amount required for the image. Only certified technicians can perform work on this equipment. Only OEM or authorized representative posses the capability to obtain part or software for the government equipment.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Contracting Officer posted Sources Sought Notice 36C25618Q9124 MEDRAD Service Contract NAIC 811219, via the Government Point of Entry (GPE)—FedBizOpps (www.fbo.gov). Resulting in four (4) responses. (See Attached)

Further due diligence was executed by the Contracting Officer via additional Market Research, by executing a search via VET BIZ under NAIC 811219, resulting in 230 results (See Attached).

Per the results, the Contracting Officer sent via email to at least three SDVOSB/VOSBs (See Attached).

Contracting Officer forward Sources Sought notice 36C25618Q9124 to various SDVOSB/VOSB identified on 811219 NAIC search in VetBiz.

Contractor BioTech Balancing (Eric Sparks) responded they would not be able to provide services requested at this time. The other two SDVOSBs and three VOSBs were non responsive.

The Contracting Officer can confirm from the Market Research responses that two or more SDVOSBs are available open market. However, the SDVOSB contractors are not able to provide evidence or documentation, such as authorized distributor of original equipment manufacturer (OEM), maintenance service agreement with OEM, or evidence illustrating they are able with low risk to the government to obtain OEM parts or software.

Although the SDVOSBs and Remi Group (Large Business) communicates the capability to provide service and possess contracts at other Veteran Affairs facilities for similar equipment, the SDVOSB and Large Business contractor fail to provide the government the required evidence. As the Contracting Officer, if the SDVOSBs or Large Business is currently providing similar services than they should possess the necessary evidence or documents required per the Sources Sought.

Novamed, in addition possess the capability to ensure the government receive any required proprietary hardware, software, and OEM trained personnel from Bayer.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable from the onset pricing factor from the prior procurement history, other awarded contracts from government agencies, and a published price catalog on the internet to assist the Contracting Officer in conducting price analysis to determine fair and reasonable pricing.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Contracting Officer posted Sources Sought Notice 36C25618Q9124 MEDRAD Service Contract NAIC 811219, via the Government Point of Entry (GPE)—FedBizOpps (www.fbo.gov). Resulting in four (4) responses. (See Attached)

Company Duns# GSA Open Market

SB VIP SAM

IMed Biomedical Company

079491910 NO YES YES YES YES

StayHome Care Solutions, Inc.

179213843 NO YES YES YES YES

NovaMed Corporation

624848875 NO YES YES NO YES

Remi Group 136662215 YES YES NO NO YES

Further due diligence was executed by the Contracting Officer via additional Market Research, by executing a search via VET BIZ under NAIC 811219, resulting in 230 results (See Attached).

Per the results, the Contracting Officer sent via email to at least three SDVOSB/VOSBs (See Attached).

Contracting Officer forward Sources Sought notice 36C25618Q9124 to various SDVOSB/VOSB identified on 811219 NAIC search in VetBiz.

Contractor BioTech Balancing (Eric Sparks) responded they would not be able to provide services requested at this time. The other two SDVOSBs and three VOSBs were non responsive.

The Contracting Officer can confirm from the Market Research responses that two or more

SDVOSBs are available open market. However, the SDVOSB contractors are not able to provide evidence or documentation, such as authorized distributor of original equipment manufacturer (OEM), maintenance service agreement with OEM, or evidence illustrating they are able with low risk to the government to obtain OEM parts or software.

Although the SDVOSBs and Remi Group (Large Business) communicates the capability to provide service and possess contracts at other Veteran Affairs facilities for similar equipment, the SDVOSB and Large Business contractor fail to provide the government the required evidence. As the Contracting Officer, if the SDVOSBs or Large Business is currently providing similar services than they should possess the necessary evidence or documents required per the Sources Sought.

Risks

IMED contractor communicated they provided services for similar equipment at Veteran Affairs, however, communicated “due to the competitive nature of the medical device service industry, it is very difficult for small/veteran owned businesses to receive OEM “authorizations” that directly compete with OEM provisions” (See Attached). Response places the risk on the government versus the contractor.

StayHome Care Solutions was not able to obtain evidence from OEM manufacturer, requested via email by the Contracting Officer. StayHome Care Solution communicated “Good afternoon Anthony. I tried to get a response from Bayer and their response is below. It's a double face from them because I am already providing a Five (5) Service Contract to Fayetteville VAMC and also provided an Emergency Repair at your facility at Houston VAMC. However, Contracting Officer notice the Sales Agreement with Bayer was not signed by Bayer.

OEM (Bayer) communication to StayHome Care Solutions “Hi Don, Legal has responded to your request. Unfortunately, we are not able to provide the documentation requested. You are not authorized to obtain software/license capability. This is proprietary and available to our Field Service Engineers which in this case act more as subcontractors to you and not your certified technicians. Our legal team is not able to fulfill these requirements as requested. They are continuing to look into the relationship we have with you to understand the process and future opportunities as this is a unique circumstance that we have not had in the past as mentioned previously. I apologize for the inconvenience (See Attached). Response places the risk on the government versus the contractor.

NovaMed contractor, obtained OEM letter from Bayer communicating Master Service Agreement (See Attached). Contracting Officer further received further communication on the role NovaMed have to ensure the procurement was not a pass through for a Large Business (See

Attached). The government risk is low and place all risk on the contractor that has provided evidence to meet the government requirement.

The evidence requested per the Sources Sought decrease the risks to the government. If the contractor is not capable of providing some form evidence such as communication from OEM they are authorized distributor or possess a Service Agreement with OEM place the government at risk. Various risk includes third party or gray market products.

Only one contractor Remi Group (Large Business) presented a GSA schedule. Per the guidance for applying VA Rule of Two 38 U.S. C. 8127(d) Supplies and Services before proceeding to an open market purchase.

Contracting Officer Per VAAR 819.7004 Contracting Order of Priority. In determining the acquisition strategy applicable to this acquisition, the contracting officer has considered the order of priority set asides. Although, two SDVOSBs responded to the Sources Sought, the two failed to provide the Contracting Officer required OEM documentation communicated the capability to meet the government requirement.

Any Other Facts Supporting the Use of Other than Full and Open Competition:

MEDVAMC Me rad System requires the services from either OEM Bayer or authorized representative to sustain operations and prevent any delays patient care or services.

These unit injectors are critical for patient care, it is used to diagnose abnormalities during radiological or MR imaging. The device must operate in tight to deliver contrast injection at the right time and at the right dose. Contrast media can be harmful to patients in quantities above the minimum amount required for the image.

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome anyBarriers to Competition before Making subsequent acquisitions for the supplies or services required: The Michael E. DeBakey VA Medical Center will consider, compare, and evaluate any alternative contractors with capability and training from original equipment manufacturer to provide maintenance services.

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.

David Miller Date Biomedical Engineer

MEDVAMC

13. Approvals in accordance with FAR 6.304

DAVID T. MILLER 1077149 Digitally signed by DAVID T. MILLER 1077149 Date: 2018.02.22 18:59:06 -06'00'

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

ANTHONY CP MARION Date

CONTRACTING OFFICER

Network Contracting Office 16

b. P&C: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Le Kisha Douglas Date

CONTRACTING CHIEF, PURCHASING AND

Network Contracting Office 16

Anthony C Marion 131115 Digitally signed by Anthony C Marion 131115 Date: 2018.02.23 06:38:49 -06'00'

Le Kisha A Douglas 157307

Digitally signed by Le Kisha A Douglas 157307 Date: 2018.02.27 09:38:04 -06'00'