J and A - Haemonetics Redacted.pdf

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

DHA PGI 213.5, Attachment 1 (06-21-2018)

Justification and Approval (J&A) for Other than Full and Open Competition

Sole Source Acquisition of Commercial Items Conducted Pursuant to Federal Acquisition Regulation (FAR) Subpart 13.5

1. Identification of the agency and contracting activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division, San Diego, CA, on behalf of the Navy to meet the requirements of the United States Navy Medicine Readiness Training Command (USNMRTC) Yokosuka.

2. Nature and/or Description of Action being approved: The USNMRTC Yokosuka at Yokosuka, Japan requests the approval to award a sole source purchase order to Haemonetics Corporation.

The government requires on-site preventative maintenance for a quantity of four (4) government owned Automated Cell Processing (ACP) 215 Units and Nutrient Additive Solution Formula 3 and De-Glyce for use with the ACP 215. The ACP 215 prolongs the shelf life of the blood supply from 24 hours to up to ten years by freezing and re-thawing the blood units. The ACP215, is manufactured by Haemonetics, the Government purchased the equipment, and it is installed at the Government facility. The reagents are critical supply items that enable the ACP 215 allow the government to pursue a rare blood inventory and build a strategic blood reserve program to support the mission of the forward deployed sailors of the United States Navy.

3. Description of Supplies/Services:

Period of Performance: One base year and four option years (1 October 2024 – 30 September 2029).

Estimated total value: $279,800.00

Item Description Price/Unit QTY Per Quarter

QTY

Per

Year Packaging

Quarterly Total Price

Yearly Total Price

Nutrient Additive Solution Formula 3, 300mL

$213.50 4 16 Case $854.00 $3,416.00

De-Glyce 325mL $1,635.80 5 20 Case $8,179.00 $32,716.00 Shipment Cost $300 1 4 - $300.00 $1,200.00

Preventative Maintanace Service $4,657.00 1 4 - $4,657.00 $18,628.00

Grand Total per year: $55,960.00

Type of Funding: Operations and Maintenance (O & M)

Contract Type: Firm-fixed-price

Requirement:

The delivery schedule for all supply items is the first week of the following months: October, January, April and July.

The preventive maintenance shall be performed quarterly at the following location: Yokosuka, Japan

4. Statutory Authority Cited permitting other than full and open competition:

This acquisition of commercial items is conducted pursuant to FAR Subpart 13.5 in accordance with 41 U.S.C. 1901 Simplified Acquisition Procedures.

5. Rationale Justifying Use of the Statutory Authority Cited:

This sole source justification is prepared using the format at FAR 6.303-2, modified to reflect the procedures in FAR Subpart 13.5 in accordance with 41 U.S.C. 1901. Based on the market research conducted, the only vendor capable of meeting the Government’s requirements is Haemonetics Corporation. While other vendors offer similar equipment and supplies, USNMRTC Yokosuka would have to replace the current system, requiring a full transition to another system. USNMRTC has four systems; the cost of replacement per system is approximately $77,000. This would result in duplicative costs of approximately $308,000 plus additional time to procure and train staff. Haemonetics Corporation is the sole manufacturer, vendor, and service provider for the Haemonetics Corporation ACP215 units. Haemonetics Corp.

maintains proprietary rights over its equipment and supplies. Haemonetics Corp. does not train or authorize other vendors to maintain or supply the ACP 215 system. Therefore, Haemonetics Corp. is the only company that can provide the required supplies and maintenance service currently installed at USNMRTC Yokosuka.

6. Efforts to Obtain Competition:

Market research was conducted by technical experts in April 2024. This research consisted of reviews of similar previous procurements, using search engines in an effort to find open market contractors, and posting a Notice of Intent to Sole Source. Search engines and websites utilized include Google, Federal Procurement Data System (FPDS), AbilityOne, Unicor, Dynamic Small Business Search (DSBS), and General Services Administration (GSA) Advantage. The only vendor identified that can provide the required supplies and maintenance service already operational at USNMRTC Yokosuka is Haemonetics Corp.

Item Description Cat. No. QTY Per Quarter QTY Per Year Packaging Nutrient Additive Solution Formula 3, 300mL 0462A-00 4 16 Case

De-Glyce 325mL 00236-00 5 20 Case

A Notice of Intent to Sole Source (HT941024N0070) was posted on the System for Award Management (SAM.gov) website from 24 May 24 – 31 May 24. The Government received a response from Metro Medical Equipment and Supply. This company advised that they are an authorized distributor of the required reagents, however they cannot perform any maintenance services. The government requirement is for the purchase of reagent supplies and preventative maintenance. The maintenance services are only provided by the manufacturer. A distributor of the same reagent is not competition. No additional manufacturers provided evidence that their product is compatible with the government owned system manufactured by Haemonetics.

The Independent Government Estimate (IGE) estimates the services above the micro-purchase threshold. Therefore, if the Government were to separate the supply and service portion of this requirement, two purchase orders would have to be solicited, awarded and managed.

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

In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price with prices found reasonable on previous purchases and a comparison of the price to the independent Government estimate provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research:

Government technical experts conducted market research in April 2024. The contracting officer in consultation with the technical experts determined that only Haemonetics Corporation can meet the Government requirements. This research consisted of reviews of similar previous procurements, using search engines in an effort to find open market contractors, and posting a Notice of Intent to Sole Source on SAM.gov. Search engines and websites utilized include Google, FPDS, AbilityOne, Unicor, DSBS, and GSA Advantage; however, no vendors other than Rees Scientific Corp. were identified.

9. Other Facts:

None.

10. Interested Sources:

The only interested source was Haemonetics Corporation. Market research and the posting of a Notice of Intent to Sole Source did not identify any additional interested parties.

11. Actions to overcome barriers:

USNMRTC Yokosuka and the DHA Western Markets Contracting Division will continue to survey and engage the market for similar products and services related to prolonging the blood supply and consider competing future requirements if there are other vendors capable of meeting the Government’s requirements.

COORDINATION:

12. Requirements Certification:

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

Yoko Miike Date Project Manager, Equipment and Supply Manager NMRTC (Navy Medicine Readiness & Training Command) Yokosuka

APPROVAL:

13. Contracting Officer Fair and Reasonable Cost Determination and Approval:

This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5. Rees Scientific Environmental Monitoring System preventive maintenance and repair services are commercially available and have been previously procured, which establishes current and historical information that will be used as a basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.403-1(b)(3). I have determined that the anticipated cost to the Government for this contract action is fair and reasonable, and I certify that this justification is accurate and complete to the best of my knowledge and belief.

Pedro Reyes Date Contracting Officer, San Diego Contracting Division