A.02.04__JA_RHCO-P-746__KO_Signed.pdf

Control Number:

18-RHCO-P-746 Limited Sources Justification or

Sole Source for Actions under the Simplified Acquisition Threshold (Currently $150K)

1. Contracting Activity: Regional Health Contracting Office-Pacific, Health Contracting Cell, Joint Base Lewis-McChord (JBLM), 673 Woodland Square Loop SE, Lacey, WA 98503.

2. Description of Action: Madigan Army Medical Center (MAMC), Department of Pathology, Joint Base Lewis-McChord, and Tacoma, WA is requesting an O6 Priority Human Papillomavirus (HPV) Testing Kits.

Requirement: X New Repeat Pricing: X Firm-Fixed Price Time & Materials Cost Funds: X OMA Other Funds: Total Dollar Value:$181,143.20

Name of Intended Contractor: ROCHE Diagnostics Street Address: 9116 HAGUE RD City, State, Zip: Indianapolis, IN 46256-1025

Phone: 503-288-1476

3. Description of Supplies/Services:

Department of Pathology pathologists and providers at Madigan Army Medical Center, WA is requesting sole source contract for the acquisition of for procuring all reagents, supplies and consumables for the Human Papillomavirus (HPV) testing. The reagents must be compatible with the existing Roche COBAS 4800 equipment located at MAMC. Due to the critical nature of the “human papillomavirus testing,” it is in the Government’s best interest to award a sole source contract to ROCHE Diagnostic Corporation without delaying patient care. This data will provide the physician with more timely and detailed pathogen information. With knowledge of specific genotypes, providers can determine different treatment options. Either with more aggressive treatment to ensure no transition from a precancerous lesion into invasive cancer, or in some cases minimize or eliminate procedures and patient trauma. These HPV testing kits is critical to patient care at MAMC. Roch Diagnostic has sole proprietary rights of the reagents and equipment.

4. Authority Cited:

X (a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a

Control Number: 18-RHCO-P-746 logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: Based on comparison with similar products in the marketplace, the MAMC's providers and pathologists are requesting specific genotyping of the HPV Pathogen has determined the reagents, supplies and consumables for the Human Papillomavirus (HPV) testing offered by Roch Diagnostic Corporation for the existing COBAS 4800 equipment best meets the requirement needs for patient care. Due to the critical nature of the “human papillomavirus testing,” it is in the Government’s best interest to award a sole source contract to ROCHE Diagnostic Corporation without delaying patient care.

6. Actions to Increase Competition: The Special Notice with J & A will be posted to FBO to increase competition.

7. Market Survey: This requirement is for surgical supplies (Class VIII). Detail, including key word searches described in the Market Research report which supports this J & A can be found in PCF A.01.01_Market Research. Market Research has been conducted by searching the Dynamic Small Business search using NAICS Code: 339112. Results from the research did not locate any small businesses that could provide the above products. Roch Diagnostic has sole proprietary rights of the reagents and equipment.

8. Procurement History:

Previous Contract or Purchase Order Number: W91YU0-15-P-0339 Previously competed? N/A X No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i)

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Signature:

Digitally signed by

BEECH.JOSHUA.CHARLES.1408345

Date: 2018.08.24 10:15:53 -07'00'

Typed Name: SGT Beech, Joshua Positions Title: Cytology NCO

Email Address: joshua.c.beech.mil@mail.mil Date: 24 AUG 2018

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

Signature:

Typed Name:

Position Title: Contracting Officer

Email address:

Date:

(17 March 2017)

BEECH.JOSHUA.CH

ARLES.1408345355

BRADBURY.LARRY.

A.1164241951

Digitally signed by

BRADBURY.LARRY.A.1164241951

Date: 2018.08.27 10:24:49 -07'00'