JA 20-RHCO-P-339 REDACTED.pdf

Version – September 2018 FOR OFFICIAL USE ONLY

Control Number: 20-RHCO-P-339

FAR Part 6 Justification and Approval for Other than Full and Open Competition

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

2. Description of Action:

a. Madigan Army Medical Center (MAMC), Department of Pathology requests a new Sole Source Indefinite Delivery, Indefinite Quantity (IDIQ) Priced Contract for Chemistry analyzer reagents, supplies, training, and maintenance for an existing Roche Diagnostic Total Laboratory Automation (TLA) system from Roche Diagnostics Corporation, Indianapolis, IN 46256. The Government projects award for October 2020 and Fiscal year 2021, Operations and Maintenance (O&M) Funds are anticipated to be available.

b. The Government-owned Roche Total Laboratory Automation System is comprised of 8100, ISE modules, c702 modules, c502 modules, e602 modules, e801 modules, and p701 storage module. The Roche Chemistry Analyzer System provides discrete random access chemistry/immunochemistry analyzer system to include but not limited to pre-analytical processing and sorting, post-analytical storage, and the ability to connect to hematology, coagulation, urinalysis, and additional testing platforms. The system shall include a middleware solution capable of managing workflow, provide auto verification capability, and be able to write customized rules for all testing platforms (Chemistry and third party) that are connected to the system.

c. This action is a follow-on to contract W81K02-16-D-0008. That contract was competed under full and open competition using Best Value continuum for the Roche Diagnostics Corporation is theonly company that is able to provide a chemistry analyzer system that is compatible with existing equipment located throughout the Department of Pathology, Madigan Army Medical Center. The Notice required by FAR 5.201 will be published. No action on the part of this office will decrease this type of barrier to competition available.

3. Description of Supplies/Services: Estimated total value is $8,770,989.00, Period of Performance: 1 October 2020 – 30 September 2021, plus four (4) one-year option periods (if exercised). Madigan Army Medical Center (MAMC), Department of Pathology requests a new Sole Source Indefinite Delivery, Indefinite Quantity (IDIQ) Priced Contract for Chemistry analyzer reagents, supplies, training, and maintenance for an existing Roche Diagnostic Total Laboratory Automation (TLA) system from Roche Diagnostics Corporation, Indianapolis, IN 46256.

Period of Performance (PoP) Value

Base 1 Oct 2020 to 30 Sept 2021 $1,754,197.80

Option Year 1 1 Oct 2021 to 30 Sept 2022 $1,754,197.80

Option Year 2 1 Oct 2022 to 30 Sept 2023 $1,754,197.80

Option Year 3 1 Oct 2023 to 30 Sept 2024 $1,754,197.80

Option Year 4 1 Oct 2024 to 30 Sept 2025 $1,754,197.80

(Estimate)Total $8,770,989.00

Title: Chemistry Analyzer R e a gent s Vendor: Roche Diagnostics Corporation Requirement Type: Reagents and Supplies

4. Authority Cited:

a. 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1(a)(2)(ii)(A), Only one responsible source and no other supplies or services will satisfy agencyrequirements.

b. Further, FAR 6.303(6)(9)(ii), A description of efforts made to ensure that offers are solicited from as many potential sources as is 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. Any other facts supporting the use of other than full and open competition, such as: Whenever FAR 6.302-1 is cited that this follow-on acquisition as described in FAR 6.302-1(a)(2)(ii) as estimate of the cost to the Government that would be duplicated and the estimates was derived from the Independent Government Estimates (IGE) and previous history of (W81K02-16-D- 0008).

5. Reason for Authority Cited:

a. MAMC is requesting a follow on contract for Total Laboratory Automation reagents, supplies, training, and service for an existing Roche Diagnostic Total Laboratory Automation (TLA) system from Roche Diagnostics Corporation. 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. Roche Diagnostics Corporation is the only authorized manufacturer,distributor, and trainer for the Government-owned Total Laboratory Automation at Madigan Army Medical Center.

b. As described at FAR 6.302-1(a)(2)(2)(ii)(A), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for Roche Diagnostics Corporation.

6. Efforts to Obtain Competition:

a. In accordance with DFARS PGI 206.302-1(d), A Sources Sought Notice was posted to www.betaSAM.gov on 29 July 2020 with a closing date of 10 August 2020. Roche Diagnostics Corporation was the only company that responded on 7 August 2020 (See attached Madigan SSE Response to W81K02-20-Q-0196) in the PCF File under the Sources Sought responses. Further, Roche Diagnostics Corporation in Part II to their response states that there are no sub-contracting and third party distribution opportunities available for the products and or services listed in the Sources Sought. Roche Diagnostics Corporation point of contact is Mr. Kyle Fox, Sr., Government Contract Consultant, Kyle.Fox@Roche.com , (Phone: 317-966-9146) and (Fax: 800-722-7222).

b. 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. However, since this is a sole source action, effective competition is not applicable.

c. Subcontracting competition:

1. In accordance with FAR 19.702(a)(1), a Subcontracting Plan is required for negotiated acquisitions over $700K. However, Roche Diagnostics Corporation stated in their response to the Sources Sought, dated 7 August 2020, that no subcontracting or third party distribution exist for these supplies.

2. The Contracting Officer has determined that no subcontracting possibilities exist for this requirement and that determination has been approved one level above the Contracting Officer level as required by FAR 19.705-2(c).

Actions to Increase Competition: Roche Diagnostics Corporation is the only authorized companythat can perform anymanufacturing,distributing,and trainingfor theTotal Laboratory Automation that is compatible with existing equipment located at Madigan Army Medical Center. The Contracting Officer shall publish the notices by FAR 5.201 and any bids or proposals received shall be considered

Market Research: Roche Diagnostics Corporation is the only authorized company that can perform any manufacturing, distributing, and training for the Total Laboratory Automation that is compatible with existing equipment located at Madigan Army Medical Center.

Additional market research was conducted using numerous sources (Please see A.01.01 in PCF labeled Market ResearchDocumentation)

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 beconsidered.

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). However, there are no possible sources available to fulfill this requirement.

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 conducted with keywords “Chemistry Analyzer with Reagent” are available on the open market. However, only Roche Diagnostic Corporation can provide Total Laboratory Automation; therefore, a sole source contract will be awarded.

e. A Dynamic Small Business Search was conducted with keyword “Chemistry Analyzer with Reagent” results from this search did not identify contractors that can provide the same or equal supplies outlined by the requiring activity.

f. Market research was conducted by personal telephone contact and internet searches with the potential vendors in the past 90 days.

g. No other source of instrumentation has incorporated their instrument into the Roche automated system line since original inquires made in 2016. Use and implementation of a nonintegrated system would require three extra full time equivalents (FTE), due to 24 hour operation and take at least six months to properly validate. The extra validation time is not rolled into the existing contract and would cause a contract overlap. It is fiscally and productively advantageous to the Government to keep the existing integrated equipment.

h. 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, only Roche Diagnostics Corporation and no other sources have written to express interest in the acquisition. Roche Diagnostics Corporation is the only authorized company that can perform any manufacturing,distributing,and trainingfor the Total Laboratory Automation that is compatible with existing equipment located at Madigan Army Medical Center.

10. Other Facts:

a. Procurement History

(1) The US Government entered into a contract (W81K02-16-D-0008) with Roche Diagnostics Corporation as part of (MAMC) Core Laboratory Automation (TLA). Roche Diagnostics currently only supports the connection of a Roche Diagnostics Corporation Chemistry analyzer system. Since Roche serves as the backbone of the (TLA) process, we must continue our contract with the Roche Diagnostics Corporation system.

(2) The Roche Diagnostics Total Laboratory Automation is the only system that connects to all instrumentation in Core Laboratory to include but not limited to Sysmex Hematology Analyzer, Diagnostic Stago Coagulation Analyzers, Arkray Urinalysis Analyzer, Beckman Coulter Flow Cytometry Analyzer, and Semen Analysis Analyzer.

(3) The Department of Pathology, at Madigan Army Medical Center is thoroughly trained on the use of this system.

(4) The previous acquisition was W81K02-16-D-0008 was completed using Full and Open Competition. The change in circumstances is listed in (1) above.

b. Other facts:

(1) Roche Diagnostics Corporation obtained a full Authority to Operate (ATO) from Defense Health Agency (DHA) allowing their Total Laboratory Automation system to operate on the DHA network. The full ATO was obtained on 10 FEB 2019. To date, Roche Diagnostics Corporation is the only vendor that has a full ATO for their products.

(2) Vendors who do not have a full ATO cannot connect to the DHA network and are thereby unable to communicate with the electronic health care record. The DHA electronic healthcare record, MHS Genesis, is the only patient care record available in the DOD and VA. Automated Laboratory instruments cannot operate as designed without a full connection to the electronic health care record. Lack of connection between the electronic healthcare record and the laboratory instrumentation creates significant patient safety risks. Access to the electronic healthcare record is required for the transfer of physician orders into the laboratory analytical system and for the transfer of results in to the patient record for viewing and subsequent action by the provider. The process to obtain a full ATO is approximately 18 months. Utilizing Roche Diagnostics saves the Government time and money by not waiting for the vendor to obtain a full ATO from DHA.

(3) Utilizing the Government-owned equipment eliminates the 6 month validation process required of newly installed instrumentations; saving retraining on a new system and money. This follow on contract will also eliminate an instrument lease or purchase payment saving the Government in excess of 2 million dollars.

(4) The Roche storage capability is 12500 samples. This meets our College of American Pathologist accrediting requirement to maintain samples for a minimum of 3 days after testing to investigate discrepancies or add on additional testing. No other vendor that can meet Madigan’s testing requirements can store that many samples and meet our storage measurement specifications.

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.

Date:

Signature:

12. Requirements Certification: I certify that the supporting data under mycognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Date:

Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that theanticipated cost or price to the Government for this contract action will be fair and reasonable.

Based on the previous history of W81K02-16-D-0008 and the total cost of this requirement.

This determination will be made using the following: cost analysis price analysis should cost IGCE audit: other:

As a part of this basis, certified cost or pricing data:

will be required.

will not be required and the following exception applies (FAR 15.403):

Prices that will be agreed upon are based on adequate price competition.

Prices that will be agreed upon are based on prices set by law or regulation.

A commercial item is being acquired.

A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

The contract action is a modification to a contract or subcontract forcommercial item(s).

The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Date:

Signature:

X

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

Date:

Signature:

X

Approval Based on the foregoing justification, I hereby approve the procurement of Chemistry analyzer reagents, supplies, training, and maintenance for an existing Government-owned Roche Total Laboratory Automation System which is comprised of 8100, ISE modules, c702 modules, c502 modules, e602 modules, e801 modules, and p701 storage module for the estimated amount of $8,710,989.00 on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(1) the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

Date:

Signature:

X