J&A_Redacted.pdf

J&A #18-10028

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD on behalf of the Department of Defense Drug Demand Reduction Program to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for six (6) automation systems, laboratory; three (3) systems for Navy Drug Screening Laboratory (NDSL) Great Lakes IL, one (1) system for Air Force Drug Testing Laboratory (AFDTL) Lackland TX, one (1) system for Army Forensic Toxicology Drug Testing Laboratory (AFTDTL) Fort Meade MD, and one (1) system for Armed Forces Medical Examiners System (AFMES) Dover DE, with options for two (2) additional automation systems, laboratory; one (1) for AFTDTL Tripler HI, and one (1) for NDSL Jacksonville FL.. e

3. Description of the supplies/services required.

The requirement is for a total of six (6) specimen preparation systems. Four (4) systems with specimen preparation and liquid verification capabilities are required; one (1) system for each of the following four locations: Navy Drug Screening Laboratory Great Lakes, IL, Air Force Drug Testing Laboratory Lackland, TX, Army Drug Testing laboratory, Ft. Meade, MD, and the Armed Forces Medical Examiners System Dover, DE. Additionally, two (2) systems with only the specimen preparation capability (no liquid verification capabilities) are required for Navy Drug Screening Laboratory Great Lakes, IL. The requirement includes operator training for all sites.

The request includes the option to procure two (2) additional systems. One option is for a system with specimen preparation and liquid verification capabilities for the Army Drug Testing laboratory, Tripler, HI. The other option is for a system with only the specimen preparation capability (no liquid verification capability) for the Navy Drug Screening Laboratory Jacksonville, FL. The options also would include operator training for each site.

The systems shall be capable of pipetting urine specimens from test tubes and performing all specimen manipulation steps to execute an extraction including delivery of reagents, plate incubation/shaking/centrifugation/sealing and producing a final extract in either a 96-well plate or individual specimen vials. The system shall include a barcode reader to ensure positive specimen identification and tracking. The system shall interface with the laboratory information management system (LIMS), laboratory IT infrastructure, and utilize custom reports. The system shall augment the automated extraction capability of the DDRP laboratories with the same model, layout, software, and hardware of the existing installed base of Hamilton Robotics STAR systems in the DDRP laboratories. The liquid verification kit is a unit that is placed on the instrument to verify the pipetting accuracy (quarterly requirement at the drug labs). The unit is meant to be moved from instrument to instrument so that you only need to purchase one unit per site. The Jacksonville lab already procured a liquid verification kit, so that is why the optional instrument for that lab does not include it. Also, since only one is needed per lab, The Great Lakes lab only needs one system that includes the liquid verification kit. The life cycle of these units are approximately 7-10 years.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1), FAR 13.106-1(b)(1), and FAR 6.302-1, brand name only. There are multiple distributors capable of providing the equipment that meets the minimum government requirements.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Hamilton Robotics is the only manufacturer capable of providing systems with the same model, layout, software, and hardware of the existing installed base of Hamilton Robotics STAR systems in the DDRP laboratories. The use of identical systems will ensure that the software, hardware, operating procedures, maintenance, and information technology requirements are consistent between instruments. The use of identical systems also allows the laboratories to perform abbreviated method/instrument validations, utilize the existing interface to the LIMS, utilize custom reports already in use, share a common inventory of consumable supplies, and utilize all information technology compliance testing and accreditation already performed on the installed base. Procurement of specimen preparation systems other than those manufactured by Hamilton Robotics to meet this requirement would result in duplicative costs, effort, and resource expenditure worth an up-front monetary value of approximately $3,953,674.00 and yearly excess sustainment of approximately $250,000.00. No manufacturer other than Hamilton Robotics is capable of providing systems with the same model, layout, software, and hardware of the existing installed base of Hamilton Robotics STAR systems in the DDRP laboratories. Only Hamilton Robotics and its authorized distributors are capable of providing systems that meet the minimum requirements of the Government.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the NECO and/or FedBizOpps in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in October through December 2017. It included a search of the Internet using Google, Bing, GSA Advantage, and the ECRI Sourcebook, and personal correspondence with representatives from the DDRP, Hamilton Robotics, and Agilent Technologies. Manufacturers who can provide automated specimen preparation systems include Hamilton Robotics, Tecan Group, and Beckman Coulter. The systems available from Tecan and Beckman Coulter are not the same model, and do not have the same layout, software, and hardware of the existing installed base of Hamilton Robotics STAR systems in the DDRP laboratories, and thus do not meet the minimum requirements of the Government. Only Hamilton Robotics and its authorized distributors are capable of providing systems that meet the minimum requirements of the Government.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and find this J & A to be legally sufficient, based on these facts, to the best of my knowledge and belief.