JA_SS_Far Part 8 - Vitros XT7600_Redacted.pdf

Limited Sources Justification and Approval (J&A)

CONTROLLED UNCLASSIFIED INFORMATION

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I. Contracting Activity.

Contracting Agency is 377 MSG/PKB on behalf of 377 MDG Medical Lab

II. Nature and/or description of the action being processed.

Continuation of lease for Ortho-Clinical Vitros XT7600 Chemistry Analyzer for use at the 377 MDG Medical Lab

III. Description of supplies/services required to meet agency needs.

This unique, proprietary machine analyzes bodily fluids, such as blood, and determines the concentration of specific substances within the samples, eg. vitamin and mineral levels, cholesterol levels, etc. The use of sterilized water is mandatory for other chemistry analyzers- but not for the Vitros XT7600. This specialized machine utilizes patented microslide/dry slide technology, which does not require the use of water to process samples. The physical space in which this machine is situated does not have a waterline to bring in sterilized water or remove contaminated water. Installing a waterline would demand considerable construction and cost, and it would cause unacceptable delays in the vital services the MGD provides Airmen.

IV. Identification of the justification/rationale for limiting sources and demonstration of the contractor's unique qualifications to provide the required supply/service.

This particular equipment does not require sterile water, unlike other chemistry analyzers. Changing to equipment that requires sterile water source would require significant construction and physical renovation of the lab. This would grossly disrupt the health services provided by the MDG and adversely impact the AF's readiness. The dry slide technology used by Ortho Clinical Diagnostics is proprietary, and therefore there are no equivalents on the market.

V. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with

FAR 8.404(d).

This order will be placed from a VA FSS contract. Per FAR 8.404, FSS contracts have negotiated prices and established fairness for the base contract to ensure best value for the government. Additionally, PKB conducted its own analysis that also determined the price is fair. Previous prices were established prior to COVID's devastating economic impact that had a gross and adverse affect on business wellbeing. Additionally, inflation has skyrocketed over the past few years, and there have been abundant supply chain issues that have also impacted business wellbeing. These factors have accounted for the price increase from the pre-COVID contract to the current prices.

VI. Description of the market research conducted and the results, or explain why market research was not conducted.

Market research demonstrated that there are no equivalent supplies in the market. The dry slide technology this system uses is patented, meaning there is an inherent lack of competition for this particular system as the technology cannot be legally replicated.

VII. Other facts supporting the justification.

This is a unique system that does not require the use of sterilized water, unlike other chemistry analyzers on the market. This feature is patented; therefore other companies cannot replicate this system, meaning there is no competition.

VIII. Actions the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services.

Until this technology is no longer patented, the government exercises limited ability to remove barriers that cause restricted

Limited Sources Justification and Approval (J&A)

CONTROLLED UNCLASSIFIED INFORMATION

April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 3 of 3April 2021 CONTROLLED UNCLASSIFIED INFORMATION Page 3 of 3 consideration in the procurement of this machine.

IX. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

X. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.