A.02.04_JA_18-RHCO-P-189_Pheno_Analyzer.pdf

Control Number: 18-RHCO-P-189

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

(23 January 2018)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Joint Base Lewis McChord Health Contracting Cell, Lacey, WA. 98503.

2. Description of Action: This is a follow on Sole Source Firm-Fixed Price Contract for Accelerate Pheno System and reagents that are used by the Microbiology Section of the Department of Pathology, Madigan Army Medical Center, Joint Base Lewis McChord, Tacoma, WA. to be funded with DHP funds for current fiscal year (FY18).

3. Description of Supplies/Services: This technology is not offered by any other company.

Accelerate is the only company using phenotypic susceptibility testing offering a rapid susceptibility test for positive blood cultures. In addition to providing a minimum inhibitory concentration (MIC) from the susceptibility test it provides identification of the organism for the most prominent sepsis causing pathogens. This will be a reagent rental with a Base Plus (2) two one-year option periods beginning on 15 February 2018 through 30 September 2018.

A breakdown of pricing information is listed below:

CLINS ACCELERATE PHENO SYS. Performance Period

0001 $0.00 (NC LEASE) 15 Feb 18 – 30 Sep 18

0002 $144,152.40 BC TEST KIT 15 Feb 18 – 30 Sep 18

1001 $0.00 (NC LEASE) 1 Oct 18 – 30 Sep 19

1002 $$144,152.40 BC TEST KIT 1 Oct 18 – 30 Sep 19

2001 $0.00 (NC LEASE) 1 Oct 19 – 30 Sep 20

2002 $144,152.40 BC TEST KIT 1 Oct 19 – 30 Sep 20

Total $432,457.20

4. Authority Cited: The statutory authority permitting other that full and open competition is pursuant to the authority of the test program for commercial items at 41 U.S.C. 1901, as implemented under FAR 13.501(a) Sole Source Acquisition (Including Brand Name) Under Test Program for Certain Commercial Items.

5. Reason for Authority Cited:

a. The Accelerate Pheno is the only company offering a combined rapid identification and susceptibility testing in the same platform. This technology will reduce hospitalization time for

(ACCELERATE PHENO ANALYZER / REAGENTS)

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

(23 January 2018) patients saving the Government money. There is only one responsible source and no other supplies will satisfy the agency requirements. Awarding a sole source basis to Accelerate is in the Government’s best interest.

b. Without the required reagents/consumables and supplies, patients within the Madigan footprint would not benefit from the timeliest screening method available and most certainly experience prolonged discomfort and possibly death.

6. Efforts to Obtain Competition:

a. Effective competition. An effort to obtain competition has not been practical since there is only one source capable of meeting the needs of this requirement. Therefore, the Contracting Officer determined a sole-source award to Accelerate Diagnostics.

b. Subcontracting competition. In accordance with FAR 19.702(a)(1), a Subcontracting Plan is required for negotiated acquisitions under $700K .

7. Actions to Increase Competition: There is currently no effort to increase competition as there is only one source capable of meeting the requirement. This is due to the manufacturer being the only source capable of providing all specifications needed. Therefore, efforts to obtain competition are not practical at this time. However, (MAMC) and (JBLM-HCC) will continue to monitor this requirement to see if there are any possible sources in the future.

8. Market Research:

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 be considered.

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). A GSA eLibrary search was conducted and several contractors were identified for SIN 66 III, Clinical Analyzers, Laboratory, Cost-Per-Test. However, GSA will not be used for this acquisition.

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 “Accelerate Pheno System” are not available on the open market. Acclerate has the proprietary right to the technology and distribution of reagents;

therefore, a sole source contract will be awarded.

e. A Dynamic Small Business Search was conducted with keyword “Accelerate Pheno System,” results from this search did not identify contractors that can provide the same or equal supplies outlined by the requiring activity, because Ortho Clinical Diagnostics, Inc. has the proprietary right to the technology and distribution of reagents.

(ACCELERATE PHENO ANALYZER / REAGENTS)

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

(23 January 2018)

f. A Sources Sought (W81K02-18-T-0016 ) was posted on https://www.fbo.gov on (26 January 2018) with a closing date of (2 February 2018).

g. CONCLUSIONS. As shown above, “Accelerate Pheno System” is not available on the open market and GSA/FSS. Accelerate is the only company that could provide the same or equal product(s) meeting the specific requirements outlined by the requiring activity. No other sources were identified from this research were found to be capable of providing the requested supplies with all the required specifications. They have the proprietary right to the technology and distribution of reagents; therefore, a sole source contract will be awarded. Per FAR 19.702(a)(1), subcontracting plans is not required for acquisitions under $650K.

h. Joint Base Lewis McChord Contracting Cell will continuously monitor any changes in this requirement along with Madigan Army Medical Center, Joint Base Lewis McChord, Tacoma, WA.

9. Interested Sources: Due to proprietary rights, other sources will not be considered at this time. Therefore, the Contracting Officer determined a sole-source award to Accelerate Diagnostics (CAGE: 0T3P1, DUNS: 186328670) for the acquisition of the Reagents and Pheno System. A Justification and Approval notice will be posted after award.

10. Other Facts:

a. Procurement history.

(1) N/A

(2) N/A.

(3) IAW FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirement.

(4) There is currently no effort to increase competition as there is only one source capable of meeting the requirement. Accerate Diagnostics is the only company that is capable of providing Reagents for the Pheno System to Madigan Army Medical Center. Based on this information, there is no effort to increase competition at this time.

(5) N/A

(6) N/A

(7) No change in procurement history.

b. Other facts. N/A

(23 January 2018)

(ACCELERATE PHENO ANALYZER / REAGENTS)

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:__________________________

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:__________________________

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:__________________________

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:__________________________

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

Jason Smedberg Deputy Chief, Microbiology

25JAN18