VEID240021_J and A-v1_1.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the requesting agency: Naval Medical Research Unit SOUTH (NAMRU SOUTH), Lima, Peru.

2. Nature and/or description of the action.

NAMRU SOUTH requests approval to award a Firm Fixed Price contract on a sole source basis for the purchase of a wide range of laboratory primers and probes. The proposed source is Biosearch Technologies, 2199 S. McDowell Blvd., Petaluma, CA 94954.

3. Description of Supplies or Services:

Both the Virology Surveillance and Virology Research and Development Departments of NAMRU SOUTH conduct laboratory processes for diagnosis of pathogens from human and animal samples, under the GEIS surveillance program.

Customized primers and probes are necessary to perform molecular diagnosis of Dengue virus (four serotypes), Chikungunya virus, Zika virus, Mayaro virus, Hantavirus, Orthobunyavirus (including Guaroa, Oropouche, Group C, Bunyamwera and California viruses), Influenza virus (Influenza A-matrix gene and B), and its subtypes (H3, H1pdm/SwH1N1, H1 seasonal); and, SARS-CoV-2. Primers and probes will be used in reverse transcription (RT) real-time PCR assays using serum, saliva, blood and/or urine samples from febrile surveillance protocols and pharyngeal swab, rectal swabs, fecal samples and/or egg culture samples from respiratory surveillance protocols.

The total estimated value of this contract is US$62,965.40.

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 U.S.C. 2304(c)(1) and FAR 13.106-1(b)(1). Only one responsible source and no other supplies will meet agency requirements.

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

NAMRU SOUTH owns and uses the 7500 Fast Real-time PCR and QuantStudio platforms, where all the above assays have been validated, and therefore, compatibility of the consumables is a requirement. Design and validation of all laboratory procedures have been standardized with these items, since they have shown to perform up to standard. Assays have been developed independently for each SOP followed in the laboratories, and reagents used must remain the same as the ones specified in the SOPs, otherwise, the design and validation of these processes would have to be reinitiated from zero, which would delay all processing and the timely diagnosis of public health relevant pathogens. Furthermore, the studies that require these processes have been ongoing for over 15 years and have always used the same reagents.

Changing the source of these materials would mean altering the validity of the results for surveillance studies that measure rates of disease across years and would severely impact the capacity of NAMRU SOUTH to perform these studies up to the funder’s standards.

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

This requirement will be synopsized on Federal Business Opportunities (FEDBIZOPPS).

Currently no other sources are being solicited. If another company submits a written interest in this requirement as a result of the announcement, the company's information will be evaluated before the purchase order is signed with Biosearch Technologies.

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 covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

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

Market research was conducted by final users in the laboratory and administrative personnel in the Virology & Emerging Infections Department. This research consisted of using search engines such as GSA Advantage, Google, and contacting possible vendors.

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

These items have been purchased for many years already and are the standard for use in the Virology & Emerging Infectious Department. From FY17 to FY23, the following orders were placed for similar items:

N32398-23-P-0406: US$49,285.24

N32398-22-P-0404: US$49,644.06

N32398-21-P-0400: US$23,152.98

N32398-21-P-0407: US$28,194.20

N44852-21-MDC-0147: US$8,675.00

N32398-20-P-0410: $43,959.52

N44852-19-MDC-0407: $344.39

N44852-18-P-0020: US$5,560.00

N44852-18-MDC-0108: US$2,772.02

N44852-18-MDC-0107: US$135.40

N44852-18-MDC-0110: US$2,485.00

N44852-18-P-0048: US$22,408.12

N44852-18-MDC-0172: US$1,444.60

N44852-18-MDC-0171: US$3,186.90

N44852-18-P-0060: US$7,773.30

PR6126745: US$5,275.00

PR6322583: US$628.56

N44852-17-MDC-0144: US$3,431.16

N63116-17-P-0419: US$34,553.82

These previous purchases have also served to determine the correct supplier and acceptable pricing.

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

N/A.

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.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contracts for the types of supplies covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible.

12. Point of Contact.

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification is Deborah M. Sharpe, who may be reached at (301) 319- 6471 or Edilberto Calma 301-319-6481.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

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.

Technical Cognizance

Dr. Maria E. Silva Department Head Centralized Laboratory javier.gil Text Box javier.gil Text Box javier.gil Typewritten Text Mr. Timothy Daniels : (301) 995-2776

Requirements Cognizance

LT Megan Schilling, MSC, USN Department Head Virology Research and Development

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer

Technical Cognizance