FA558720P0001 Coagulation Analyzer Maintenance - Justification.pdf

Single Source Justification (Simplified Acquisition)

November 2018 Page 1 of 2

The 48 MDG requires a comprehensive maintenance service on its STA Compact MAX coagulation analyzer. The contractor shall maintain a coagulation analyzer with technical support required to provide outpatient and inpatient coagulation test analysis. Contractor care includes furnishing all equipment, maintenance, supplies for operation of equipment, labor, transportation, reports and technical assistance. Tests required shall cover the range of basic through comprehensive coagulation testing services including Protime (PT) with calculated INR, Activated Partial Thromboplastin Time (APTT) and D-Dimer, as well as the capacity to expand if future coagulation testing.

The current maintenance service is expiring 1 November 2019 and must be replaced in order to offset excessive costs due to call out charges incurred if a malfunction develops. This will be a sole-source procurement to Diagnostica Stago using sole-source procedures under FAR 13. Diagnostica Stago is the only source permitted to perform maintenance on its instruments. The company does not train nor provide parts to third-party companies. They stated that any maintenance on their instruments performed by a representative other than Diagnostica Stago will void any present or future warranties. This is an industry standard practice and any void in warranty would result in excessive costs to the

48MDG.

If a maintenance contract is not held with the manufacturer, then there is a requirement of two preventative maintenance visits per year ) in order for the company to be called out in the event of a breakdown. There would then be an initial call out charge , labor charged per hour along with the price of parts needed, which can be very costly. Before an engineer is sent out to a repair, a purchase order must be executed and since a service agreement is not in place, 48 MDG would not be held as a priority call out. The estimated contract cost of is for a five year period and estimated per year. Without a contract, the cost is at which does not include parts or total number of hours required for repairs. As a result, it is more advantageous for 48 MDG to proceed with a contract with Diagnotica Stago.

A search of GSA Advantage using the term "Coagulation Analyzer" was performed. The following companies were listed as providing analyzer services; - Provides to be used with analyzers, -

Coagulation Analyzer only, -products only, - products only., products only. Each of the companies searched did not give any indication that they maintain analyzers from another manufacturer, they only supported their own machines and products.

A search on the Diagnostica Stago website (www.stago.com) showed the products and their applications. No other companies were listed as being licensed to perform maintenance on Diagnostica Stago products.

Previous purchase orders for this service were sole sourced and research has shown that coagulation maintenance for other DOD contracting agencies, AirForce, Navy and Army, were sole source procurements as well.

Single Source Justification (Simplified Acquisition)

November 2018 Page 2 of 2

A request for information (RFI) was posted on FBO on 24 September 2019. A draft Performance Work Statement was included with the RFI. Industry was given an opportunity to comment and provide alternative means of accomplishing the requirements by 30 September 2019. No comments were received.

The manufacturer of the STA Compact Max coagulation analyzer, Diagnostica Stago, was reached out to initially in

2016 to procure information about its instruments and third-party vendors. Their coagulation sales specialist , replied by stating that it does not allow other companies to provide parts or maintenance to its devices, and that any maintenance performed by such shall result in voiding any future warranty or service agreements. The intended life cycle of the analyzer is 8 years and until 2024 when it is replaced, there is no expectation of competition.

The STA Compact Max Coagulation Analyzer was purchased in FY 16 as a result of an open market solicitation.

Replacing the machine before the end of its intended life cycle is not advisable as any costs incurred due to additional man hours and resources to re-solicit would not be expected to be recovered through additional competition. When the need for the instrument to be replaced occurs, solutions to this issue shall be taken into account as part of life-cycle costs. In addition, there is a plan to cost compare the possibility of using the when it is released to open market, predicted to be July 2019 but to our knowledge is still not available as of October

2019.