JA Sole Source FAR Part 13.5_Redacted.pdf

Title: Date:

Requirements Representative:

Typed Name: DSN: (

Title: Date Reviewed:

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Fort Cavazos Health Contracting Branch

2. Description of Action: This is a new requirement for Cost Per Reportable Results (CPRR) using the Beckman and Coulter Urinary Analyzers supplies and reagents for Carl R. Darnall Army Medical Center, Fort Hood, TX. The DxU Iris Workcell helps to isolate, identify, and characterize urine particles on the screen to virtually eliminate the need for manual microscopy. CRDAMC requires an FDA approved multi-faceted urine analyzer system that can also perform analysis of multiple body fluids cell counts. This procurement will consist of using the Contractor’s analyzers along with the necessary CPRR to support the Hospital’s needs. Contractor shall provide unscheduled maintenance according to the CPRR agreement to include parts, and labor on the DxU 850 Workcell. The Government shall not exercise any supervision or control over the contract providers performing the agreement herein. The contract will include all usage of the contractor’s DxU 850m DxS and IQ/AZ Workcell 3 (AX-4030) equipment and associated consumables. This requirement will be met with FY 25 funds: Subject to funds availability.

3. Description of Supplies/Services: The Government-owned Iricell Velocity and Iricell iQ200 was installed March of 2016 making it greater than seven (7) years old which put it beyond its life expectancy for accurate analysis and performance.

This Cost Per Reportable (CPR) program includes the equipment and associated consumables (all reagents, controls, and calibrators necessary to operate the system with Beckman Coulter part numbers). A reportable is considered one cycle of the instrument that increments the cycle counter, excluding reported control and calibrator runs.

The Government will be charged a monthly rate for the use of 3,500 reportables per on the Primary or Secondary Urine Chemistry Analyzers, and 3,500 reportable per month on the Microscopy Analyzer. Additionally, there are 100 reportables per month on the Body Fluids Module on the Microscopy analyzers.

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

5. Reason for Authority Cited: Beckman Coulter urinalysis systems are the only UA analyzers that are FDA-cleared to perform multiple body fluids cell counts. The DxU offers linearity down to zero to facilitate automated analysis and eliminate the need for manual cell counts on CSF (Spinal), pleural (lungs and chest), peritoneal (Pelvic Cavity), synovial (Joint fluids; pre-treaded with hyaluronidase), and pericardial (abdomen) fluids. The DxU is the only urinalysis system that offers a <4% manual microscopic review rate due to Auto Particle Recognition (APR) classifies and quantifies all reportable particles to ensure high quality results.

6. Efforts to Obtain Competition: General Supply Schedule (GSA) eLibrary was assessed to identify other vendors who may meet this requirement under GSA Federal Supply Schedule (FSS) -GSA 66 III.

Beckman Coulter is among three (3) GSA Contractors who provide CPRR for Urine (UA) supplies and Analyzers. All three vendors are manufacturers of the equipment that they rental/lease. CPRR are not interchangeable and must be of the same brand as the manufacturer’s UA analyzer. Though Beckman Coulter authorizes other vendors to offer supplies to the public, as stated in the sole-source letter, Beckman Coulter is the manufacturer and only authorized provider and maintainer of its analyzers. Beckman Coulter’s UA analyzers are the analyzers that are FDA-cleared to perform analysis of multiple body fluids cell counts. The DxU offers linearity down to zero to facilitate automated analysis and eliminate the need for manual cell counts on CSF (Spinal), pleural (lungs and chest), peritoneal (Pelvic Cavity), synovial (Joint fluids; pre-treaded with hyaluronidase), and pericardial (abdomen) fluids. This unique capability expands the availability of this system amongst various departments within CRDAMC. No other UA analyzer possess this capability. Per Beckman Coulter Inc. Original Equipment Manufacturer (OEM) sole source letter (dated January 2024), the vendor is the exclusive provider of the FDA cleared equipment. There are no current subcontracting opportunities available.

7. Actions to Increase Competition: This is a New Requirement. As part of the efforts to obtain competition, in accordance with FAR 5.202 a Notice of Intent to Award Sole Source (w/ the redacted LSJ) will be posted in Sam.gov as required by FAR Subpart 5.2.

8. Market Research: Market research was conducted by Contract Specialist, from 24 July 2024 to 22 August 2024. A portion of CPRR supplies is available for purchase via DLA’s Electronic Catalog (ECAT). However, ECAT does not offer rental, leasing, or loan of UA analyzers with CPRR (supply) purchases. Therefore, this requirement is being procured externally because the awarded contractor’s equipment will be provided as part of the contract.

Market research reflects that Beckman Coulter, Inc. provided quote for CPRR with analyzers is similar to prices that are generally offered.

There are three (3) known Contractors who provide CPRR for Urine Analyzers. Though methodology slightly varies, their offerings typically consist of the opportunity to procure CPRR supplies with equipment at a flat-rate or through a tailored evaluation of the customer’s specific needs and usage. Sysmex America’s Inc flat rate at an estimated 3,500 CPRR offers the highest pricing rate. Siemens Healthcare Diag Inc. CPRR options are extensive and are only available through consultation with the contractor.

Because market research indicates that this requirement will be sole source, a request for pricing will not be pursued. Beckman Coulter’s flat rate is based upon 300+ or more CPRR per month. Beckman and Coulter Inc. tailored quote results in a cost benefit for specific CPRR categories. Based upon the pricing comparisons, the anticipated cost to the Government for this contract action will be fair and reasonable.

The market research results revealed that there are not two or more ‘authorized’ Small Businesses that can provide CPRR for a urine analyzer that is FDA cleared to support analysis of multiple body fluids cell counts per the Requiring Activity’s need. The manufacturer, Beckman Coulter, Inc. is a Large Business (0HWD8), therefore the Nonmanufacturer rule applies. Due to the Requiring Activity’s need for Cost Per Reportable Result Agreement for the Beckman and Coulter Urinary Analyzer, the requirement is Sole Source.

9. Interested Sources: A sources sought notice was not posting on Sam.gov. Per Beckman Coulter Inc. Original Equipment Manufacturer (OEM) sole source letter (dated January 2024), the vendor is the exclusive provider of the FDA cleared equipment. A Notice of Intent to Award Sole-Source will be posted on Sam.gov.

10. Other Facts: This instrument enhances lab efficiency by allowing technicians to multitask while the analyzer processes specimens. It also holds an approved Authority to Operate (ATO) and integrates seamlessly with MHS Genesis. Implementing a new vendor could take up to 18 months or more. The VA hospital in Temple Texas and Seton Medical Center in Harker Heights utilize the DXU/Iris allowing for sharing of reagents if necessary.

a. Procurement history. N/A – New Requirement.

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:

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.

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.

The basis fair and reasonable, will be determined by using pricing for similar CPRR on GSA and the independent Government estimate.

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

Approval

Based on the foregoing justification, I hereby approve limiting sources in the acquisition of Cost Per Reportable Result (CPRR) Agreement for the Beckman and Coulter Urinary Analyzers to be procured at $668,339.00 (Base plus 4 options and possible 6-month extension) 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.