JA 21-RHCO-P-54 redacted.pdf

Control Number: 21 RHCO P 54

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS –

SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: This is to procure a lease of a hematology Analyzer to include reagents, supplies, training and service for connection to existing Roche Diagnostic Total Laboratory Automation (TLA). For Madigan Army Medical Center (MAMC) Department of Pathology at Joint Base, Lewis-McChord Tacoma WA.

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5

Amount: The estimated value of this requirement is $531,630.00

Prepared by:

Contracting Officer:

Technical:

Requirements:

Contract Specialist Email:

Contracting Officer

Supervisor, Core Lab

Supervisor, Core Lab

Reviews: I have reviewed this justification and find it adequate to support sole source.

Contracting Officer:

Typed Name: Signature:

Program Manger Typed Name: Signature:

Local Advocate for Competition Typed Name: Signature:

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

Contracting Activity: Joint Base Lewis McChord Health Contracting Branch (JBLM-HCB), Lacey, WA 98503

Description of Action: Madigan Army Medical Center (MAMC), Department of Pathology requests a new Sole Source Firm Fixed Price contract. The Government projects award for OCT 2020 and Operations and Maintenance funds will be used.

Description of Supplies/Services: This is a requirement for the lease of a hematology analyzer (including reagents, supplies, training, and service) for connection to existing Roche Diagnostic Total Laboratory Automation (TLA). The estimated total value and period of performance, including options, are provided asfollows:

Base Period: 01OCT20 – 30SEP21 Value: $177,210.00 Option Period 1: 01OCT21 – 30SEP22 Value: $177,210.00 Option Period 2: 01OCT22 – 30SEP23 Value: $177,210.00

Total: $531,630.00

Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implementedby FAR Subpart 13.501(a)(1)(i), sole source (including brand name).

Reason for Authority Cited:

MAMC is requesting a follow on contract for the Lease of a Hematology analyzer (including reagents, supplies, training, and service) from Sysmex America Inc. The US Government entered into a contract (W81K02-16-D-0008) with Roche Diagnostics as part of MAMC Core Laboratory’s transition to Total Laboratory Automation (TLA). TLA provides the greatest leap forward for providing the highest quality patient test results in the shortest time period. TLA helps to reduce the need for physicians to have to order STAT tests because all tests are handled and resulted in the shortest time period possible. With TLA, long term staffing requirements are reduced thereby saving in civilian personnel costs. Sysmex America Inc. is the only Hematology analyzer manufacturer authorized and compatible with the existing Government owned Roche TLA per Roche Diagnostics.

6. Efforts to Obtain Competition:

otices required by FAR. 5.201 and any bids or proposals received shall be considered.

A source sought notice was posted to betaSAM on 2SEP20 and closed on 8SEP20, and no responses were received.

Effective Competition: In the future, Joint Base Lewis McChord Health Contracting Branch along with the Department of Pathology will continue to perform market research to monitor any changes in the status of this requirement. As technology becomes available, research will be performed to consider other possible sources that may meet or exceed this current requirement.

Subcontracting competition: The estimated value of this procurement is not expected to exceed $700,000 and therefore is not subject to the subcontracting requirements identified in FAR 19.702.

Actions to Increase Competition: No action on the part of this office will decrease this type of barrier to competition available. JBLM-HCB as well as the Department of Pathology will continuously monitor any changes in this requirement.

Market Research: Market research was conducted in the past 12 months and shows that there are other manufacturers of Hematology analyzers. However, the results of market research determined that only one vendor is able to meet the requirements specified in the salient characteristics. Sysmex America manufactures the only hematology analyzer that is capable and authorized of interfacing with Roche Diagnostic’s TLA.

a. FAR 8.002(a)(1)(i) through FAR 8.002(a)(iv), which addresses supplies (including Federal Prison Industries and Ability One), are not applicable and will not be considered.

b. A review of FAR 8.002(a)(1)(v) was conducted and consideration to General Service Administration (GSA) and/or Federal Supply Schedules (FSS). Not applicable

c. FAR 8.003, Use of Other Mandatory Sources does not apply.

d. FAR 8.004, Use of Other Sources, and FAR 12.1, Acquisition of Commercial Items, Google search for hematology analyzers conducted with keywords ‘complete blood count’ did show other vendors are available on the open market. However, only Sysmex has the authorization to connect to Roche’s TLA.

e. A Dynamic Small Business Search was conducted using the NAICS of 325413 and the keyword of “stain” showed one possible vendor as their narrative indicates that they make stains but did not mention whether or not they make stains for the Government owned system.

f. Joint Base Lewis-McChord Health Contracting Branch will continuously monitor any changes in this requirement along with the Department of Pathology, Madigan Army Medical Center, Joint Base Lewis-McChord,WA.

9. Interested Sources: To date, no other sources have written to express interest in the acquisition.

10.Other Facts:

Procurement History:

Contract W81K02-19-P-0229 was awarded for 12 months only for 1OCT19 - 30SEP20.

Contract W81K02-16-C-0005 was award for a 12 month base period of 1OCT16 – 30SEP17 plus two 12-month option periods.

W81K02-19-P-0229 W81K02-16-C-0005 was Other than Full and Open competition.

The authority cited if Other than Full and Open competition:

If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

The to FBO. It does not appear that any vendors responded to the notice.

If any prior contract for this requirement was accomplished using Full and Open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A.

An explanation of any unusual patterns that may be revealed by the history. NA

If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

11. Technical Certification: I certify 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.

Typed Name:

Title: Supervisor, Core Lab Signature

12. Requirements Certification: I certify 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.

Typed Name:

Title: Supervisor, Core Lab

Signature

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. The basis for this determination will be price analysis in accordance with FAR 15.404-10(b). As part of this basis, certified cost or pricing data is not required because the items being acquired are considered commercial.

Typed Title: Contracting Officer Signature

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name:

Title: Contracting Officer Signature