Final JA redacted II.rtf

MENU Health Affairs DHA t Toggle Left Side Menu Site Nav This page contains dynamic content - Highest Possible Classification is UNCLASSIFIED/FOR OFFICIAL USE ONLY

Procurement Policy and Acquisition Systems Division

Director of Staff Health Care Administration Support/CAE Locations Services MHS Transformation

Close

Get Connected!

Qi J:

Contact the Administrator for permissions and content changes.

Administrator

SMirt.eCFhuanrlcetsioJnaaml:es FOR OFFICIAL USE ONLY - Source Selection Information - See FAR 2.101 and 3.104 Justification and Approval (J&A) for Federal Acquisition Regulation (FAR) Subpart 13.5 Other than Full and Open Competition Sole Source Acquisition Title: COVID Testing Supplies rn rn

HIDE

J&A Number:

Created By:

JA-23-0027

HORST, Jessica

Additional POCs: Jackson, Annette CIV Identification of the agency and contracting activity:

Tidewater Contracting Division Nature and/or Description of Action being Approved:

new contract Description of Supplies/ Services:

This requirement is for COVID-testing supplies. A base plus 4 option period contract is requested, with PoP Start Date to be 1 January 2023. The amount of the base year (and each subsequent option year) is $339,592.40, with a total contract amount of $1,697,962.00. This contract will be Firm Fixed Price (FFP) based on the quoted amount from the vendor, utilizing O&M funding.

TOTAL Contract Value POP: From 1/1/2023 to 9/30/2027 Estimated Value $1,697,962.00

BASE

POP: From 1/1/2023 to 9/30/2023 Estimated Value $339,592.40 Qgtions: Yes Type of Contract (Primary): FAR 16.202 Firm-Fixed-Price Number of Options: POP (All options): From

Funding Type:

Operations & Maintenance (O&M)

file_0.png file_1.jpg file_2.jpg file_3.wmf file_4.wmf file_5.wmf

Statutory Authority Cited permitting other than full and open competition:

41 U.S.C. 1901 Simplified Acquisition Procedures

See also FAR 13.5©M l,ag 6l:di0Qlil<ilS\!;lil r tiJ::ah,sJof<lt:>l Y it rn;sa pim11lfi e.la1¥il1Mbere11i 61iuigt.ams F1dJ!lilaJitl'l<1t:lll.eLSu i tl!llil.d' with any other items. There are no other reagents from different vendors that can be used with the existing analyzers. Hologic is the sole source of the required supplies and no other supplies will satisfy the requirements of the Government. Hologic provided a letter on 10 November 2022 indicating these supplies are the "sole source of the instrument system, assay kits, associated kits and reagents."

file_6.wmf

Rationale Justifying Use of the Statutory Authority Cited:

The requirement is for COVID-Testing supplies to be utilized on the Hologic analyzer, which can only be operated with supplies proprietary to Hologic. Hologic provided specific documentation that their analyzers can only operate using Hologic assays, reagents, tubing, etc. Hologic, has the SARS CoV-2 Assays and supplies that must be used in operation of the Hologic Panther Analyzer that is owned and operated by the NH Jacksonville. These assays shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on the instruments. The assays shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the contractor's reagents on the analyzer. Hologic does not sell through dealers or distributors in the U.S. and all sales are made directly to the end users through them. One item included in this COVID supply package does have two authorized vendors however based on the low dollar value of the item and expected administrative costs it is in the best interest of the government to maintain all supplies on one contract vehicle.

C.

6. Efforts to Obtain Competition:

ai I

This requirement will be posted to SAM.gov on or about 29 November 2022 in accordance with FAR 5.2.

X a, "Cl C

7, Determination that Anticipated Cost to the Government will be Fair and Reasonable:

Previous historical contracts in addition to similar type supplies will be reviewed and analyzed to ensure price is fair and reasonable.

<( I 0

8. Market Research:

<f) a, <f) a, Cl:'.

Market Research Conducted? Yes

When was it conducted? 8/1/2022 to 9/30/2022

Description:

Market Research was performed via online research through the Hologic, Inc. website to determine whether substitution items were available or able to be used on the existing analyzers. Through online re and discussions with the vendor representative, it was determined that these items are proprietary and cannot be substituted with any other items by any other suppliers.

N/A Other Facts:

Interested Sources:

N/A file_7.wmf

Procuring a whole new system at this time would not be in the government's best interest as the analyzer is already owned and operated by the clinical laboratory at NH Jacksonville. The Hologic analyzer that was recently purchased had many requirements that only they could provide to include an analyzer that could test for numerous infectious diseases and able to handle normal conditions as well as surge conditions. Only Hologic was capable of supplying an analyzer that did not exceed the maximum allowable footprint or weight limitations as to not create facility modifications. Purchase from any other vendor with a different footprint could have potentially cost the government funding in modifying the structure, electric and or plumbing. This analyzer has a life span of approximately 5 more years which will align with this supply procurement. This requirement will be reviewed to see if there are additional avenues to overcome the barriers to competition to include market research and if current market conditions have changed that allow for competition.

11, Actions to overcome barriers:

Technical/Functional Representative:

Coordination & Approval I certify that the information provided in this justification is accurate and complete to the best of my knowledge and belief.

file_8.png file_9.wmf

Name: Proper, Andrea Title: Supervisory Contract Specialist Approved: Proper, Andrea - 21 Nov 2022, 15:08:03 Comments:

file_10.wmf

Requirements Certification:

file_11.png file_12.wmf

I certify that the inforim,:, a Piiilltld ad:Jifll llitis::j stifillatioA1i ecal:lililtlillil¢ Billll ete Osllile,Jtle.stslfIm 1BrT®Vte!:l!l Bla1m. b§llieJoNLv Name: Proper, Andrea Title:

J-Directorate Office:

Supervisory Contract Specialist Approved: Proper, Andrea - 23 Nov 2022, 09:50:19 file_13.png file_14.wmf

Comments: PLEASE SEE ATTACHED: Hardcopy J&amp;A Form signed by LT Juan Alvarez Rodriguez, Laboratory Department Head at Naval Hospital Jacksonville. LT Alvarez is not available in SharePoint for signature, and therefore provided a handwritten signature for Requirements Certification. I have signed the SharePoint version in order to keep this version moving forward.

Fair and Reasonable Cost Determination:

Certified cost and pricing data will not be required per FAR 15.403-1(b)(3). Basis for fair and reasonable cost determination will be supported by the IGE, price comparison to similar type items and historical contracts.

C.

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

Name: HORST, Jessica Title: Contracting Officer, Tidewater Contracting Division Approved: HORST, Jessica - 21 Nov 2022, 15:09:14 Comments:

ai I file_15.png file_16.wmf

"a,' "a,' Cl:'.

15. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Name: Hatch, Julia P. CIV NMLC Title: Office of General Counsel Approved: Hatch, Julia P. CIV NMLC -29 Nov 2022, 10:01:24 Comments:

16. Contracting Officer:

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

file_17.png file_18.wmf file_19.png file_20.wmf

Name: HORST, Jessica Title: Contracting Officer, Tidewater Contracting Division Approved: HORST, Jessica - 29 Nov 2022, 10:08:41 Comments:

file_21.wmf

17. Competition Advocate: Based on the foregoing justification, I hereby approve the procurement of COVID Testing Supplies on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 Simplified Acquisition Procedures, subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Name: Dr. Jake Lewis Title: Competition Advocate (DAD-P&C) Approved: Lewis, Jake, CIV, DHA - 29 Nov 2022, 11:58:40 file_22.png file_23.wmf

Comments: Approval is contingent up demonstrated market research that another four year contract is in the best interest of the government. If not available, I would recommend a two year agreement be put in place so that proper marketing and requirements development can be done. Second, the government should not be relying upon the vendor to compare market prices. If so, they should be providing &quot;other than certified price and cost data&quot; notification to the government. Third, if these &quot;supplies&quot; are particular to a manufactor, why aren&#39;t we using that authority?

Attachments Hologic Sole Source Letter for Reagents and Consumables.pdf J&A Form - NH Jacksonville Lab DH Signed.pd/ Delete Delete file_24.png file_25.wmf file_26.png file_27.wmf

Close Version: 141.0 Created at 11/21/2022 2:34 PM by file_28.png file_29.wmf

HORST, Jessica Last modified at 12/1/2022 2:17 PM by Workflow file_30.jpg file_31.wmf

Submit Service Request

Start here. Go anywhere CONTACT US: Web & Mobile Technology PMO SERVICES MILSUITE No FEAR Act Accessibility/Section 508 CONTACT GSC: 800-600-9332 or Visit the Global Service Center site here: https://gsc.health.mil/