19-RHCO-P573_SSJ_HPV_kits.pdf

Control Number: 19-RHCO-P- 573

Sole Source Justification and Approval Under FAR 13.501

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: This is a new contract. 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. This approval is for a 3 yr Firm-Fixed Price (FFP) contract renewal (base + 2 option years) utilizing OMA funds with a total dollar value of $350,447.58.

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 are requesting a sole source contract for the acquisition of all reagents, supplies and consumables for the Human Papillomavirus (HPV) testing. Due to the critical nature of the “human papillomavirus testing,” it is in the Government’s best interest to award a sole source contract renewal 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 are critical to patient care at MAMC. Roche Diagnostic has sole proprietary rights of the reagents and equipment.

Roche Diagnostics shall provide a Cost Per test for Molecular Diagnostics analyzer, the COBAS 4800, and reagents capable of running multiplex testing for qualitative detection and genotyping of the DNA of Human Papilloma Virus (HPV) at Madigan Army Medical Center (MAMC). The COBAS 4800 is not be limited to HPV detection and genotyping and may be expanded to include other PCR testing for other pathogens. Roche will supply HPV Detection Kits (240T/960T), HPV Control Kits, and Consumables necessary to run the assay, field service support, and training as indicated in the Statement of Work at an estimated cost of $350,447.58 for base plus 2 option years.

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

(25 February 2016)

Control Number: 19-RHCO-P-573

(See FAR 2.101 and 3.104-4)

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source of Roche HPV testing kits under the authority of the simplified procedures for certain commercial items.

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 Roche 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.

The COBAS 4800 system is the only system that is currently approved by the FDA for ASC-US triage, co-testing and first-line primary screening with co-test for genotyping.

The COBAS 4800 can be used for HPV primary screening, utilizing integrated HPV16/18 genotyping and cytology reflex of the 12 other high risk HPV genotypes, and is the only methodology that accepts the primary specimen container. This reduces lab error and the potential for cross-contamination by eliminating the need for transfer into a secondary vial prior to testing. The COBAS 4800 is also the only platform for HPV testing with internal cellularity controls ensuring no false negatives if used as a primary screening method.

The COBAS 4800 system is the only HPV platform that has an approved Authority to Operate (ATO) on the DHA network and is bi-directionally interfaced with the LIS.

6. Efforts to Obtain Competition: A general competitive effort is made throughout the requirement review process which considers the applicability of products & services from various sources to determine the one that best meets the needs for the requirement and the patients.

a. Effective competition. The notice required by FAR Part 5.201 was posted to FBO on 10 Sept 2019 notifying potential offerors of the Government’s intent to award this requirement. Interested vendors were asked to respond by 12 pm (Pacific) on 13 Sept with a capabilities package. Only one response was received.

The incumbent, Roche Diagnostics Corporation, replied stating they could meet all the requirements.

b. Subcontracting competition. N/A

7. Actions to Increase Competition: The COBAS 4800 system is the only system that is currently approved by the FDA for ASC-US triage, co-testing and first-line primary screening. The COBAS 4800 can be used for HPV primary

(See FAR 2.101 and 3.104-4) screening, utilizing integrated HPV16/18 genotyping and cytology reflex of the 12 other high risk HPV genotypes, specific genotyping for HPV which our current testing currently lacks. The Roche COBAS 4800 is also the only platform for HPV testing with internal cellularity controls ensuring no false negatives if used as a primary screening method.

The Sole Source Justification, 18-RHCO-P-746, for current contract W81K02- 18-P-0282 is located in PCF Cabinet PANHCA-19-P-0000 008415.

8. Market Research: In accordance with FAR 10.002(b)(2), the following searches were completed: Direct communication with knowledgeable people in government and industry, internet search, Dynamic Small Business Search and GSAebuy. Research concluded on 21 August 2019.

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

The notices required by FAR 5.201 shall be published, and any bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history.

(1) The current contract W81K02-18-P-0282 is for 13 months, 28 Aug 2018 through 30 Sept 2019 and has a value of $181,143.20.

Previous contract W91YU0-15-P-0339 was for a one year base period and two option years with a total value of $631,989.00.

(2) The current contract W81K02-18-P-0282 was a Sole Source acquisition awarded to Roche Diagnostics Corporation.

Contract W91YU0-15-P-0339 was a Sole Source acquisition awarded to Roche Diagnostics Corporation.

(3) The authority cited for W18K02-18-P-0282 Sole Source acquisition was FAR 13.501(a).

The authority cited for W91YU0-15-P-0339 Sole Source acquisition was FAR 13.106-1(b)(1)(i).

(4) Previous Justification.

W18K02-18-P-0282 - The Roche COBAS 4800 system is the only system that is currently approved by the FDA for ASC-US triage, co-testing and first-line primary screening. The Roche COBAS 4800 can be used for HPV primary screening, utilizing integrated HPV16/18 genotyping and cytology reflex of the

(See FAR 2.101 and 3.104-4)

12 other high risk HPV genotypes, specific genotyping for HPV which our current testing currently lacks. The Roche COBAS 4800 is also the only platform for HPV testing with internal cellularity controls ensuring no false negatives if used as a primary screening method.

W91YU0-15-P-0339- The Roche COBAS 4800 is the only system that is currently approved by the FDA for ASC-US triage, co-testing and first-line primary screening that types the specific HPV genotype (e.g., genotypes 6, 11, 16 or 18) present in the specimen. This is new technology that is currently only provided by Roche

(5) Not applicable.

(6) Not Applicable

(7) The Roche COBAS 4800 system is the only HPV platform that has an approved ATO to operate on the DHA network and is bi-directionally interfaced with the LIS. Switching to a new analyzer would cause a delay in patient care and potential for patient safety issues until a bi-directional interface can be approved and established.

b. Other facts. None

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: William Gibson Title: Supervisor, Microbiology

12. Requirements Certification:

9/13/19

(See FAR 2.101 and 3.104-4)

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: DARIN HOUFEK Title: HEALTH SYS SPC

(See FAR 2.101 and 3.104-4)

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 based on cost analysis conducted IAW FAR 15.404-1(b)(2)(ii) - a cost comparison of historical prices paid. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Typed Name: Title:

14. Contracting Officer Certification:

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

Typed Name: Title: _________________

15. Approval

Based on the foregoing justification, I hereby approve the procurement of Roche COBAS 4800 HPV Testing Kits and Consumable Supplies 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.

Typed Name: Title: