LSJ_Over_SAT-Werfren Redacted.pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

36C241-24-AP-1984

Effective Date: 02/01/2022 Page 1 of 5

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-24-AP-1984

(1) Contracting Activity: Department of Veterans Affairs, Regional Procurement Office East, Network Contracting Officer 1 (New England) on behalf of VISN 1 Network Consolidated Laboratory (NCL).

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The request is to establish a federal supply schedule (FSS) blanket purchase agreement (BPA) with Werfren USA, LLC. for GEM Premier blood gas analyzers, reagent cartridges, supplies and rental equipment of Blood Gas Analyzer Systems required for patient testing in the VISN 1 VA Medical Centers (VAMC’s).

The BPA plan is firm fixed price for five years from 7/1/2024-6/30/2029. The federal supply schedule pricing for reagents and supplies for each site include additional value-added items such as data management software, service/support, installation, and on-site training and consumables. Currently across VISN 1, all VA Medical Centers performing laboratory blood gas testing are utilizing GEM blood gas analyzers.

The intent of this BPA is to continue to support VA owned blood gas analyzers already in place at two VAMC’s and allow the remaining VAMC sites in VISN 1 to continue to remain standardized with these sites. Two of the VA sites in VISN 1 own the blood gas instruments and they are fully functioning with no issues. Changing to a different vendor would require these two sites to take these instruments out of service. The anticipated cost for the new BPA is $1,265,445.00.

Order against: FSS Contract Number: GS-07F-128DA

Name of Proposed Contractor: Werfren USA, LLC

Street Address: 180 Hartwell Rd

City, State, Zip: Bedford, MA 01730-2443

Phone: 402-709-7774

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(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 1,265,445.00.

Blood Gas testing is required as part of medical care provided by VISN1 VAMC’s. It is an important part of laboratory testing. Blood gas analysis is used to evaluate the amount of oxygen and carbon dioxide and the acid-base balance, or pH, in the blood. Blood gas testing is primarily used for diagnosis and monitoring of different medical conditions such as lung and breathing disorders, kidney problems and acid-base imbalances. Blood gas testing is critical testing especially in ICU and OR settings.

The Wefren USA, LLC. GEM PAK is designed to allow for facilities to achieve budget control by having a 100% GEM PAK guarantee and designing the system to provide a designated sample test volume (quality control is included at no additional costs associated). All GEM PAKs go through rigorous quality checks prior to shipment that include 100% sensor/CO-Oximetry NIST traceable liquid testing, ETC testing, which far exceeds normal LEAN/Six Sigma testing. These quality checks allow Werfen to provide a 100% cartridge guarantee to customers.

GEM Premiere instruments have their own data management system with remote access and control available via GEM web.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; GEM Premier instruments include iQM/iQM2 (Intelligent Quality Management/Intelligent Quality Management) which is a unique, FDA cleared technology, only available on the GEM Premier analyzers. This provides continuous quality monitoring through 5 continuous quality checks that provide before, during and after sample quality checks to assure quality results for every sample. These quality checks include:

•System checks •Sensor checks, using multiple levels of NIST-traceable Process Control Solutions (PCSs) •Pattern Recognition checks -to identify errors, i.e. micro-clots, that are undetectable by traditional QC.Werfen has collected years of field sensor data to develop a unique software that allows the GEMPremier systems to be the only blood gas analyzers to detect common errors from pre-analyticalprocesses. It is crucial to have the most accurate patient result when treating critical patients.

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•New IntraSpect technology (on the GEM Premier 5000) – 15 quality checks performed during everysample analysis. The GEM Premier 5000 is the only blood gas analyzer to provide a quality check duringthe sample measurement process.

•PCS stability checks to ensure stability of the closed system and the process control solutions throughPAK use-life.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The vendor, Werfen USA, LLC, is considered to be the best value as they are a GSA contractor, considered fair and reasonable. Past performance was researched through Duns & Bradstreet and CPRS.

Positive results were shown on all accounts. Werfen blood gas analyzers are already in place and all staff have been fully trained on the equipment. The Government would incur significant cost if an award was made to anyone other than Werfen USA because staff would need to be retrained and the existing equipment would need to be replaced.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

VIP, SBA & GSA were used to conduct market research. Werfen USA is the only provider that carries the GEM Premier products. They do not have any other authorized distributors of the GEM products. Only Werfren USA, LLC is the seller and producer of their products and equipment.

(7) Any Other Facts Supporting the Justification: No other sources carry the GEM Premier 4000/5000 instruments or supplies. The VA medical centers (with the exception of Boston) have been using these products for the past 6 years and the staff are fully trained on proper usage.

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HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.