Approved JA.pdf

J&A Control: 20‐RHCO‐C‐407

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: WBAMC – Pathology requests approval of a sole-source contract for sexually-transmitted disease (STD) test and reagent kits with incidental equipment.

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

Amount: $3,504,987.50

1 Oct 20 – 30 Sep 21 $700,997.50 1 Oct 21 – 30 Sep 22 700,997.50 1 Oct 22 – 30 Sep 23 700,997.50 1 Oct 23 – 30 Sep 24 700,997.50 1 Oct 24 – 30 Sep 25 700,997.50

Total $3,504,987.50

Prepared by: Troy A. Loge Contract Specialist Date: 11 Aug 2020 Email: troy.a.loge.civ@mail.mil

Contracting Officer: Randall P. Cummins Contracting Officer Date: 11 Aug 2020 Email: christina.m.mokrane.civ@mail.mil

Technical: Jorge Munoz Dept of Pathology COR Date: 11 Aug 2020 Email: Jorge.munoz2.civ@mail.mil

Requirements: Alicia Munoz Supervisor Microbiology Date: 11 Aug 2020 Email:

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

Legal Counsel:

Eugene J. Smith

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

1. Contracting Activity: Regional Health Contracting Office – Central (RHCO-C), Fort Carson Cell, WBAMC

2. Description of Action: WBAMC – Pathology requests a firm, fixed-price contract with Hologic. The government projects award for August 2020 and fiscal year 2021, DHP Operations and Maintenance type funds will be used.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

The contracting officer has approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B).

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting contracting officer approval.

This action is a follow-on to contract W81K0020P0106. That contract was not competed under authority FAR 13.106-1(b)(1). Paragraph, “Actions to Increase Competition” of the previous justification, stated: N/A. No actions were accomplished due to the historical lack of available competition.

3. Description of Supplies/Services: This requirement is for William Beaumont Army Medical Center, Department of Pathology, for a one-year base with four (4) one-year options for sexually-transmitted disease (STD) testing and reagent kits with incidental support equipment for the testing of Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) combination, Human Papilloma Virus (HPV), Trichomonas Vaginalis (TV), and Human Papilloma Virus Genotypes 16, 18/45. A Hologic Panther analyzer is currently in place at WBAMC under contract W81K0020P0106, however, a new Hologic Panther analyzer will be required for the WBAMC facility.

Base Period: 1 Oct 20 to 30 Sep 20 Value: $700,997.50 Option Period 1: 1 Oct 20 to 30 Sep 21 Value: $700.997.50 Option Period 2: 1 Oct 21 to 30 Sep 22 Value: $700.997.50 Option Period 3: 1 Oct 22 to 30 Sep 23 Value: $700.997.50 Option Period 4: 1 Oct 23 to 30 Sep 24 Value: $700.997.50

Total: $3,504,987.50

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5(a)(1)(ii):

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other: Only one responsible source

5. Reason for Authority Cited: The Gen-Probe Inc. (Hologic) Panther system is currently the only fully-automated molecular (nucleic acid amplification technology) multi-test, single platform analyzer possessing the required capabilities and FDA approval to support all STD testing performed at WBAMC.

Chlamydia/Gonnorhea Human Papiloma Virus (HPV) HPV Genotyping Trichomonas Bacterial Vaginosis (BV) Candidiasis Mycoplasma Genitilium

HSV 1&2

The Contractor supports the usage of ThinPrep, a DLA-supported contract for collection of PAP smears at WBAMC. Cytology equipment owned on-site supports ThinPrep usage and HPV, HPV Genotypes, CT/NG, and TV must be able to be tested from the PAP smear collections at the provider’s request.

The Contractor is able to support all tests as FDA-approved. Market research confirms that analyzer and all tests are FDA-approved.

Abbott has an analyzer that is able to support ThinPrep and meets the size restriction for a single, multi-test platform. However, the Alinity is not FDA instrumentation as of now and their testing meu release for FDA-approved tests if the instrumentation is approved 4th quarter 2019 will not include Candidiaisis or Bacterial Vaginosis.

The ATO requirement may be the only issue. If there is a vendor for STD testing that is able to support WBAMC with an ATO and meet the requirements, this would not constitute a sole-source. Market research was not able to confirm which vendors do or do not have an ATO.

Because of the long history of this requirement having been sole-sourced, the lack of any interested offerors in response to sources-sought and special notices of intent to award sole-source posted over that history, the likelihood that there will be no new entrants into this narrow market any time soon is high, and the RMF process requiring a lengthy vetting process for approval to operate (ATO) equipment on the government network, a longer-term contract with an established, well-performing contractor is necessary to ensure minimal disruption to this vital portion of WBAMC’s mission.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201. A sources-sought notice was posted 31 Jan 2020 to beta.SAM yielding no interested offerors, as has been the result from each of the past four single-year, sole-source acquisitions, listed at paragraph 10.

7. Actions to Increase Competition: A sources-sought notice was posted 31 Jan 20 to beta.SAM, producing no interested offerors. A notice of intent to award sole-source will likewise be posted to beta.SAM and all offerors submitting responses with proper documentation of available supplies and equipment support will be forwarded to WBAMC, Ft Bliss, TX for technical review and consideration for future requirements.

WBAMC will continue to evaluate the capabilities of other vendors and seek new sources that will satisfy the requirement through market research.

8. Market Research: Market research conducted October 1-31, 2019 by WBAMC – Pathology via the web, telephonic and electronic inquiries and sources-sought notices.

Market research revealed three contractors, however, only two can support ThinPrep for STDs and only one is able to also support Candidiaisis. This requirement will be advertised as a sole-source to Hologic as no other vendors were found to meet all requirements. Market research was unable to verify who had an ATO.

9. Interested Sources: No responses were received from interested offerers when a sources-sought notice was posted to beta.SAM 31 Jan 20. To date, no other sources have written to express interest in this acquisition.

10. Other Facts:

a. Procurement History.

W81K0020P0106, awarded 31 Mar 2020, sole-source IAW FAR 13.106-1(b)(1)(i).

W81K0019P0408, awarded 1 Oct 2019, sole-source IAW FAR 13.106-1(b)(1)(i).

W81K0018P0253, awarded 29 Mar 2018, sole-source IAW FAR 13.501(a)(1)(ii).

W81K0017P0712, awarded 1 Oct 2017, sole-source IAW FAR 13.106-1(b)(1)(i).

W81K0016P0512, awarded 1 Oct 2016, sole-source IAW FAR 13.106-1(b)(1)(i).

b. All awarded contracts have been sole-sourced to Gen-Probe Inc. (Hologic).

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

Jorge A. Munoz

COR, WBAMC DPALS

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.

Alicia Munoz Chief, Microbiology (Acting)

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.

This determination will be made using the following: price analysis cost analysis IGCE audit: N/A other: Procurement history

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Randall P. Cummins Contracting Officer

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

Randall P. Cummins Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of STD testing and reagent kits with incidental equipment support in the amount of $3,504,987.50 on a sole-source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the supplies herein described have otherwise been authorized for acquisition.

Liza J. Esmond Command Advocate for Competition