Single_Source_Justification_Siemens_Analyzer-Reagents.pdf

Single Source Justification (Simplified Acquisition)

March 2018 Page 1 of 2

Section A: General Contract Information

Is this a Bridge Action as defined in the AF Bridge Action Reduction Plan? Yes No

Contracting Activity: 436 CONS/PKB

Project/Program Name: Siemens Analyzer & Reagents (Sole Source)

Purchase Request/Identification Number: F1Q4ME8222A001

Estimated Contract Cost (including Options): $436,904.75

Section B: Description of the Supplies/Services Required

Contractor shall provide a cost per reportable test contract for the purpose of performing general chemistry blood tests and ligand/hormone blood tests. This contract will include the chemistry instrument, primary reagents, calibrations, and consumable reagents to produce chemistry test patient results. The contractor shall also provide preventative maintenance and repair/servicing, Monday - Friday from 8 AM - 5 PM.

Section C: Justification for Soliciting from a Single Source or Brand Name

Currently, the 436 MDG laboratory uses the Siemens Healthcare Diagnostics EXL 200 Chemistry Analyzer. The current platform has performed 2 years beyond its life expectancy and has required more frequent repairs over the last 12 months. The laboratory work environment, storage, and work-flow is designed specifically for this platform. Circumstances include:

1) The Siemens EXL has been chosen due to specific requirements, such as the available testing (it performs all general chemistry testing to include immunoassays), as well as limited space requirements (it must fit within a 61" x 56" space).

2) High humidity levels in the laboratory. The Siemens EXL uses wet reagents which mitigates any fluctuation in humidity levels. Any instrumentation utilizing dry reagents will be problematic due to climate.

3) Storage availability in the laboratory. The laboratory is currently designed for the storage of refrigerated wet reagents. The storage requirements of wet reagents is refrigeration. The laboratory currently has three (3) refrigerated storage systems which includes backup refrigeration and dedicated alarm systems. Any chemistry platform requiring frozen storage, such as the Vitros S600 Integrated System, will require the turn-in of two (2) refrigerators, the purchase of 2-3 freezers, the purchase of a temperature monitoring alarm system & configuring. The laboratory is currently unable to accommodate significant frozen storage space.

4) Local manufacturer support. Siemens Healthcare Diagnostics is headquartered in Newark, Delaware. Close proximity to the manufacturer means that service requests and replacement part orders are filled quickly.

5) The 436 MDG laboratory's current quality assurance, quality control, dilution procedures, pipette and chemical dilution procedures are designed for the Siemens Healthcare Diagnostics EXL 200 platform. Changing platforms would require a significant overhaul of current procedure and process manuals, to include retraining all staff, and reprogramming the Healthcare computer system.

Section D: Efforts to Obtain Competition

The laboratory has explored other manufacturers of wet reagents; however none were found that meet our specifications.

Additionally, Red One Medical is a SDVOSB partnered with Siemens Healthcare. Unfortunately, Red One Medical does not provide multi-function analyzers or cost-per-test services.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

Single Source Justification (Simplified Acquisition)

March 2018 Page 2 of 2

Due to the climate at Dover AFB, it would be impossible to eliminate the humidity that requires the use of wet reagents.

Additionally, with the implementation of future DHA guidelines regulations may be put into place that mandate equipment to be used by hospitals and clinics.

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date

11-Jan-2019

Typed Name and Rank/Grade of Contracting Officer

JUAN ROMAN, MSgt

Signature of Contracting Officer

ROMAN.JUAN.JR.125926726

Digitally signed by

ROMAN.JUAN.JR.1259267265

Date: 2019.01.11 15:55:50 -05'00'