A.02.04_USAHCA_Sole_Source_Justification_under_13.501_(Re-dacted).docx

Control Number: 19-RHCO-C-1 Control Number: 19-RHCO-C-1

(Analyzers and Reagents for IACH)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office-Central, Fort Hood Cell, Fort Hood, Texas.

2. Description of Action: Approval for a follow-on contract to Ortho Clinical Diagnostics, to provide on-site clinical chemistry and immunodiagnostic analyzer and reagent services at Irwin Army Community Hospital (IACH). The proposed award is firm fixed price, Defense Health Program (DHP) Operation and Maintenance (O&M) funds will be used for this requirement.

3. Description of Supplies/Services: Non-personal services to provide clinical chemistry and immunodiagnostic analyzer and reagent services for IACH. The estimated total value is $, which includes the Option to Extend Services under FAR clause 52.217-8. This request is for commercial items and funds are not available and contingent upon Congress enacting FY19 appropriations. The period of performance is:

Base Period: 1 October 2018 – 30 September 2019 Option Period 1: 1 October 2019 – 30 September 2020 Option Period 2: 1 October 2020 – 30 September 2021 Option Period 3: 1 October 2021 – 30 April 2022

4. Authority Cited: The statutory authority permitting other than full and open competition 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items".

5. Reason for Authority Cited: This requirement is for clinical chemistry and immunodiagnostic analyzer and reagent services located at IACH. Current chemistry testing uses a dry technique, negating the need for plumbing. The contractor is currently the only contractor who meets testing requirements while using a dry technique. If the Government were to choose another chemistry analyzer, which requires external water supply and effluent, the current water/drain services would need to be retrofitted. Currently, using the Vitros 5600, the Chemistry Department has 240v electrical supply (floor mounted) at each analyzer and no requirement for water supply/effluent. The hospital would need to supply water through ceiling drops (since existing supply is to the sinks in the casework) and would have to tear up the concrete flooring to install a drain at each instrument. This would, in all likelihood, be quite costly and involve outside contractors, would disrupt operations (totally shutting down Chemistry at a minimum and most likely Hematology as well), which would incur considerable costs and delays in patient care.

6. Efforts to Obtain Competition:

a. Effective competition. Research was conducted by searching the Dynamic Small Business Search at http://dsbs.sba.gov/dsbs/search/dsp_dsbs under NAICS Code 325413, which identified no vendors “analyzers and reagents”. Results from this search did not identify two or more small businesses that could provide the same or equal products.

b. Subcontracting competition. In accordance with FAR Subpart 19.705.2, the Contracting Officer has taken actions to determine whether a proposed contractual action requires a subcontracting plan. According to the System for Award Management (SAM) Ortho Clinical Diagnostics is a large business, and a subcontracting plan does apply. DFARS 252.219-7003 and FAR 52.219-9 will be incorporated into the solicitation and the award, putting the responsibility of creating a small business subcontracting plan on the awardee. Therefore, the awardee must utilize small businesses.

7. Actions to Increase Competition: Previous justification located in the paperless contract file (PCF). The Government will continue to seek new resources that will satisfy these requirements through continued market research, request for Statements of Capability, and telephonic inquiries.

8. Market Research: A sources sought was posted to FedBizOpps from 9 May 2018 – 14 May 2018, two vendors replied, Ortho Clinical Diagnostics and _____ , stating they would be interested in this requirement. Although both vendors expressed interest in this clinical chemistry and immunodiagnostic analyzer and reagent requirement, extensive market research revealed only Ortho Clinical Diagnostics offers testing requirements while using a dry technique. On 17 May 2018, the Contract Specialist conducted a telephonic inquiry with ______, to ask if they use liquid chemistry reagents, and to ask if they offered the dry technique. The answer was “yes we use liquid chemistry reagents and no we do not offer the dry technique”, the POC also stated that “Ortho Clinical Diagnostics is the only company to offer the dry technique”. A follow up email dated 17 May 2018 was sent to _____ asking if they use liquid chemistry reagents. The answer was yes, they have liquid chemistry reagents. Based on the market research, ______ is not acceptable.

9. Interested Sources:

Vendor: Ortho Clinical Diagnostics POC: Greg Coons E-mail: greg.coons@orthoclinicaldiagnostics.com Phone: 585-453-6141

Vendor: _______

POC:

E-mail:

To date, no other sources have written to express an interest.

10. Other Facts:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected:

(1) Contract Number: W81K00-17-P-0193 (1 April 2017 – 30 September 2018), W81K00-17-P-0105 (1 January 2017 – 31 March 2017), and W81K00-16-P-0335 (1 October 2016 – 31 December 2016).

(2) The competitive status of these actions. W81K00-17-P-0193 sole source. W81K00-17-P-0105 and W81K00-16-P-0335 full and open competition, Ortho Clinical Diagnostics was the only vendor to respond.

(3) Authority previously cited if less than full and open competition was used. N/A

(4) Previous procurement’s summary of contents of paragraph 7: Regional Health Contracting Office – Central will continue to evaluate the capabilities of other vendor’s products and re-procure the system equipment that provides the best value to the Government.

(5) 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.

- This requirement was competed using full and open competition for the past three consecutive acquisitions; however, there is only one company who can provide testing requirements while using a dry technique. Solicitations have awarded to only Ortho Clinical Diagnostics, therefore the Contracting Officer decided to pursue the sole source route with contract number W81K00-17-P-0193.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

- In the past, there were three acquisitions for this requirement, which posted to FedBizOpps as “unrestricted”, no other company submitted a quote, subsequently this requirement has only been awarded to the same large company for the past three years.

(7) No other business could provide the requested services of the previous procurement. There have been no significant changes.

b. Other facts. N/A.

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.

Signature: ________________________________Date: ________ Typed Name: ____________________Title:__Laboratory Manager______

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.

Signature: ________________________________Date: _________ Typed Name: ____________________Title:___Management Analyst_____

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Signature: ________________________________Date: __________ Typed Name: ______________________Title:_Contracting Officer_____

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: ___________ Typed Name: ______________________Title:_Contracting Officer______

Approval Based on the foregoing justification, I hereby approve the procurement of clinical chemistry and immunodiagnostic analyzers and reagents for the base and all options not to exceed $, on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: ________________________________Date: ___________ Typed Name: _____________________Title: Special Advocate for Competition For Official Use Only (See FAR 2.101 and 3.104-4) (25 February 2016)

For Official Use Only (See FAR 2.101 and 3.104-4) (25 February 2016)