Inactive
Notice ID:N0025922N0065
THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. Reference#: N0025922N0065. Naval Medical Center San Diego (NMCSD) intends to award a firm fixed ...
THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. Reference#: N0025922N0065. Naval Medical Center San Diego (NMCSD) intends to award a firm fixed price contract under the authority of FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs, to: Karius, Inc. 975 Island Dr. STE 100 Redwood City, California 94065-5173 The North American Industry Classification System (NAICS) code for this requirement is 621511; the business size standard is 35.0 (millions of dollars). The objective of this sole source award is to procure supplemental service for infectious disease diagnoses of culture negative infections or diagnosis of infections in patients where biopsy or sampling of the suspected infection is precluded due to instability of the patient or inoperable nidi at NMCSD’s Laboratory Department, services. The Naval Medical Center San Diego (NMCSD) Laboratory Department has a requirement for quantitative next- generation sequencing done on cell free, whole plasma for a broad range of pathogens, to include DNA viruses, bacteria, fungi, molds, mycobacteria and protozoa is required. Cell free DNA of pathogens can be found in blood regardless of infection site and source. In general, because of the critical nature of the testing and instability of the patients being tested, results are required in 24-72 hours after receipt into contract laboratory. Laboratory professionals who perform testing must possess the technical skills associated with this testing methodology. The reference laboratory will provide a copy of its CAP accreditation certificate as required by CAP as well as their Clinical Laboratory Improvement Amendments (CLIA) certificate. The reference laboratory must act in accordance with commercial laboratory practices. All subcontracted referral laboratories used by the vendor must also meet the above requirements. Laboratory reports must comply with the Health Insurance Portability and Accountability Act (HIPAA) regulations with necessary HIPAA clauses included. Per HIPAA Part II CFR 164.501, 164.502, 164.506, laboratory services are considered indirect physician providers. Reports will include medical liability clauses for non-personal medical services. Information provided in the reports must comply with the College of American Pathologists (CAP) standards. At minimum, vendor must be able to identify and quantify pathagens listed in the Statement of Work (SOW). Requirement is for 125 tests to be processed with a period of performance to take place from 1 Oct 2022 to 30 Sep 2023. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work and are able to provide valid certification to provide service validated by Karius, Inc. Capability statements shall not exceed 6 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order. Capability statements are due by 08:00 AM Pacific Daylight Time, 03 August 2022. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: Nicole.e.ventinilla.civ@mail.mil . The email subject line shall state, “Naval Medical Center San Diego, Special Notice Number N0025922N0065.” NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED