JOFOC Redacted.pdf

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

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 5 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-21-AP-4217

1. Contracting Activity: Department of Veterans Affairs, VISN 21, Medical Center Network Contracting

Office 21 (NCO 21) Requiring Activity: Biomedical Engineering, VA Palo Alto Healthcare System, 3801 Miranda Ave, Palo Alto, CA 94304

PR: 640-21-2-500-0380

2. Nature and/or Description of the Action Being Processed: This procurement is for corrective and preventative maintenance on two BioMerieux Vitek analyzers 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. The proposed firm-fixed price purchase order will be a new contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The proposed action is to provide corrective and preventative maintenance services on two Biomerieux Vitek analyzers. The contractor will ensure that each unit is maintained and serviced by manufacturer-trained technicians and that the services are performed according to manufacturer’s specification using manufacturer parts. The services will include remote tele-diagnotics for troubleshooting the equipment and telephone support calls around the clock. These services are required to ensure that the microbial analyzers, which are used in Veteran care, are operating at optimal capacity.

The total estimated value of the proposed action is

The estimated period of performance is as follows:

Base period 09/01/21 – 08/31/22 Option Period 1 09/01/22 – 08/31/23 Option Period 2 09/01/23 – 08/31/24 Option Period 3 09/01/24 – 08/31/25 Option Period 4 09/01/25 – 08/31/26

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 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 Requirements

( ) Unusual and Compelling Urgency

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( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Vitek analyzers are highly technical, complex, and specialized cell analysis equipment containing proprietary technology, parts, and software. As such, manufacturer-trained technicians are required to service the analyzers.

Biomerieux Inc. is the original equipment manufacturer (OEM) of the Vitek analyzers and has the trained technicians to provide the maintenance services. As the OEM, the company has full access and data rights to the parts, software, and proprietary technology that is required to provide the corrective and preventative maintenance services according to manufacturer specifications.

At this point in time, Biomerieux does not have an authorized service provider who can provide the maintenance services. If another company were to attempt repairs on the analyzers, the work would jeopardize the integrity of the equipment and potentially cause critical failure, which would negatively impact the service and care to the Veterans. This in turn would require the analyzers to be replaced with the same equipment or an analyzer similar to the Vitek analyers. Accordingly, Biomerieux Inc. is the only firm capable of providing the 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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In an effort to locate additional sources, a Sources Sought Notice was published on Contracting Opportunities under synopsis 36C26121Q0800. The notice was published on 23 June 2021 with responses due 30 June 2021; included with the notice was a drafted copy of the Statement of Work. Only one company submitted a response: CenMed Enterprises (CenMed), a WOSB. According to the technical capabilities statements, CenMed is a maintenance agreement management firm. They provide on point of contact for their customers who wish to incorporate multiple service agreements under one contract; CenMed uses their network of contacts with Individual Service Organization and Original Equipment Manufacturers to provide the necessary repair services and manufacturer parts. An investigation through the company’s website confirmed the information provided in the technical capabilities statement.

The contract specialist forwarded CenMed’s response to the project point of contact and Government subject matter expert (SME) for his technical review. The SME concluded that CenMed would not be providing any service for the VHA other than scheduling repairs. There was a concern will a delay in service because the Government would first need to contact CenMed instead of the OEM directly. Furthermore, there was a concern that CenMed would not be able to provide the remote diagnostic service through modem access as required by the Statement of Work because our internal Information Security Office procedures require a contract with the company performing the remote diagnostic. It was his understanding that only the OEM, Biomerieux Inc., could provide this remote diagnostic service due to the proprietary software installed in their equipment.

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To verify this matter, the contract specialist sent an email inquiry to the CenMed representative who submitted the company’s sources sought notice response. The representative confirmed that their diagnostic service is limited to telephone support; they are not capable of providing the remote diagnostic service through modem connection. Thus, the contract specialist and SME concluded that CenMed Enterprises is not technically capable of performing all the required tasks in the Statement of Work.

Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. There is no competition anticipated for this acquisition.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: To assess the market prices, the contract specialist searched for various microbial analyzers that are similar to the Vitek 2 and Vitek MS analyzers; however, all manufacturers and authorized service providers require requests for quotes. The companies do not publish their service prices or service agreement plan prices; this seems to be the customary practice for this industry.

The contract specialist then queried Contracting Opportunities and Federal Procurement Data System – Next Generation (FPDS-NG) to locate recent contracts awarded for microbial analyzer repairs. Results revealed very few contracts for other analyzers; the contracts that were located were predominantly for Biomerieux Vitek analyzers and all contracts located were awarded on an approved sole-source justification. Thus, the contract specialist concludes that in order to determine a fair and reasonable price for this procurement, the prices offered by the Biomerieux, Inc., will be compared to the historical contract prices on VA261-15-C-0112 while also considering a annual 3% inflation rate.

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

Market Research Was Not Conducted: 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.

Searches through mandatory sources, AbilityOne and UNICOR, revealed that both programs could not be utilized for this procurement.

Searches through the NAC Contract Catalog Search Tool (CCST), NAC Federal Supply Schedules, and the Supply Chain Master Catalog (SCMC) did not reveal an existing VA or NAC contract that could be utilized.

Searches through GSA e-Library revealed contract GS-07F-9525S with Biomerieux, Inc. The contract specialist sent an email to the Point of Contact (POC), Connie Wagner, to confirm if the GSA contract could be utilized for this procurement. Connie stated that the GSA contract does not allow for services task order; thus, the GSA contract could not be utilized for this procurement.

Online searches for microbial analyzer repairs revealed one company, ACS Industrial Services, as a potential source for Biomerieux Vitek maintenance services; however, continued investigation through the company’s website revealed that ACS Industrial Services only repairs one specific part:

the circuit board. The company does not offer corrective and preventative maintenance services for

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Revision 03 Date: 02/11/2021 the entire equipment; thus, ACS Industrial Services is not technically capable of meeting this requirement.

Searches through the Vendor Information Pages (VIP) Database under NAICS 811219 and keyword “vitek” revealed zero firms. Similarly, searches through the SBA Dynamic Small Business Search (DSBS) tool under the same NAICS and keyword revealed zero firms.

Because this proposed action does not require the contractor to access Protected Health Information, it is not necessary to sign a Business Associate Agreement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: In accordance with

38 U.S. Code §8127 and 13 CFR §125.6, there are limitations on subcontracting. A prime contractor awarded an SDVOSB contract can not pay more than 50% of the amount paid by the government to it to firms that are not VIP-listed SDVOSBs. As such, a SDVOSB firm cannot act as a passthrough entity by subcontracting more than 50% of the services and maintenance of the two Vitek analyzers to the manufacturer. This limitation on subcontracting applies to all small businesses.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Biomerieux Inc.

100 Rodolphe St Durham, NC 27712-9402

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: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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.

Date

Chief, Biomedical Engineering VA Palo Alto HCS

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.

Rico Johnson Date

Rico L. Johnson Digitally signed by Rico L. Johnson Date: 2021.07.09 05:54:55 -07'00'