Inactive

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) intends to ... The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) intends to procure, on a sole source basis, preventive maintenance, emergency service, support, and coverage for a Government-owned Illumina NovaSeq 6000 sequencing system (S/N A01064) from Illumina, Inc., 5200 Illumina Way, San Diego, CA 92122, United States. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(2); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System (NAICS) code is 811219 and the business size standard is $22 million. 1.0 BACKGROUND The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) requires preventive maintenance, emergency service, support, and coverage for a Government-owned Illumina NovaSeq 6000 sequencing system (S/N A01064). The NovaSeq 6000 is used for Next Generation Sequencing (NGS) assays requiring high throughput and depth including Whole Exome Sequencing (WES), Whole Genome Sequencing (WGS), Transcriptome Sequencing (RNAseq) and/or for clinical cancer panel (TSO500) performed in NCI Comprehensive Oncologic Molecular Pathology and Sequencing Service (COMPASS) clinical sequencing WGS laboratory. These clinical sequencing assays are used for the patient enrolment in NCI clinical protocols and patient treatments. Scheduled maintenance and proactive service of diagnostic equipment are requirements for all clinical laboratories performing and reporting complex assays on human materials to maintain accreditation. These maintenance services are required for the facility to remain accredited and continue to serve the NIH patient population to the benefit of the Government. The equipment must be calibrated accurately and maintained according to the manufacturer’s specifications. 2.0 SCOPE The Contractor shall provide all labor, material, and equipment necessary to maintain and provide preventive maintenance, emergency service, support, and coverage for a Government-owned Illumina NovaSeq 6000 sequencing system (S/N A01064) including its configured PC with software located on site at the COMPASS LAB within LP. All equipment maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturer’s (OEM) most current standard commercial maintenance practices. Onsite emergency service shall be provided during standard business hours (defined as 8:00 A.M. – 5:00 P.M. EST, Monday through Friday, excluding Federal Holidays found at http://www.opm.gov/operating_status_schedules) and extended hours (5:00 P.M. – 9:00 P.M. EST, Monday through Friday) for any issue which cannot be resolved remotely. Software and applications service may be performed remotely as applicable. All travel, labor and related charges shall be included. Software updates and support services (technical services, clinical applications support, remote diagnostics) shall be provided remotely as indicated in Section 3.0 below. 3.0 CONTRACTOR REQUIREMENTS AND PERSONNEL QUALIFICATIONS 3.1 PREVENTIVE MAINTENANCE The Contractor shall perform one (1) planned preventative maintenance during the period of performance on the NovaSeq 6000 sequencing system. Technically qualified OEM trained service engineers shall perform inspections and services.. The service shall consist of a thorough cleaning, calibration, adjusting, alignment, inspection, verification and validation testing for each component of the equipment in accordance with the manufacturer’s latest established service procedures. All equipment shall be operationally tested through at least one (1) complete operating cycle at the end of the preventive maintenance inspection to assure optimum and efficient performance. 3.2 EMERGENCY SERVICE Unlimited on-site, emergency repair service visit shall be provided during the period of performance of this Purchase Order at no additional cost to the Government. Emergency service shall be provided during standard business hours (defined as 8:00 A.M. – 5:00 P.M. EST, Monday through Friday, excluding Federal Holidays found at http://www.opm.gov/operating_status_schedules) and extended hours (5:00 P.M. – 9:00 P.M. EST, Monday through Friday) for any issue which cannot be resolved remotely. Upon receipt of notice during standard business hours that any part of the equipment is malfunctioning the Contractor shall respond within one (1) hour and dispatch a qualified factory-trained service representative within 3 business days to inspect the malfunctioning equipment and perform all repairs and adjustments to restore the said equipment to normal operating condition. Emergency service calls shall not replace the necessity for planned preventative maintenance. All labor and travel shall be included. 3.3 REPLACEMENT PARTS The Contractor shall furnish all required replacement parts at no additional cost to the Government, with the exception of consumables. Parts shall be genuine OEM parts that are new to original equipment specifications. If the parts are in stock, the Government expects delivery to be the next day. 3.4 SOFTWARE UPDATES/SERVICE The Contractor shall provide software service and required updates in accordance with the manufacturer’s latest established service procedures. These services shall include unlimited toll-free telephone, email, and online submission to OEM-trained technical support personnel for the use of program software and trouble shooting of the operating systems, at no additional cost to the Government. The Contractor shall receive advance approval for the installation of all software updates and revisions from the Government. Defective software shall be replaced at no additional cost to the Government. Unlimited remote technical support for trouble-shooting the instrument and clinical application shall be 8hrs/day, 5 days/week. 3.5 PERSONNEL QUALIFICATIONS Technically qualified factory-trained personnel shall perform the service to the Illumina NovaSeq 6000 sequencing system including its configured PC with software as covered by this Purchase Order. All primary service personnel shall have at least one backup support person with at least the same level of expertise on the equipment covered by this Purchase Order. 3.6 SERVICE EXCLUSIONS The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire or water. These repairs shall be the subject of a separate Purchase Order and shall not be performed under this Purchase Order. 4.0 TYPE OF ORDER This is a Firm-Fixed-Price Purchase Order for severable services. Funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not roll over for use in other periods. 5.0 PERIOD OF PERFORMANCE The period of performance shall be for twelve (12) months from May 01, 2021 to April 30, 2022. 6.0 PLACE OF PERFORMANCE Onsite services shall be performed at the following location: NIH, NCI, 10 Center Drive Bldg. 10, Room 4A22 Bethesda, MD 20892 7.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR The Government-owned NovaSeq 6000 sequencing system must be calibrated accurately and maintained according to the manufacturer’s specifications by authorized Original Equipment Manufacturer (OEM) trained service engineers. The NovaSeq 6000 is used for Next Generation Sequencing (NGS) assays requiring high throughput and depth including Whole Exome Sequencing (WES), Whole Genome Sequencing (WGS), Transcriptome Sequencing (RNAseq) and/or for clinical cancer panel (TSO500) performed in NCI Comprehensive Oncologic Molecular Pathology and Sequencing Service (COMPASS) clinical sequencing WGS laboratory. Accurate and trustable data generation is the most important requirement of a clinical assay and it can be achieved through regular maintenance, proactive monitoring of the systems, and ability to fix any unexpected issues encountered at any time. Any deviation from the design specifications during the required services will compromise the integrity of data for ongoing research studies. Illumina, Inc. is the original manufacturer, distributor, and the sole provider of preventive maintenance service, emergency service, proprietary firmware maintenance/upgrades, genuine OEM replacement parts, and OEM-trained technical support for troubleshooting and diagnosing issues that arise during regular operation of the instrument. The required services are not authorized through any other entity. Additionally, the annual preventive maintenance is required to maintain laboratory accreditation with Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) and necessary to provide the highest standard of performance for complex clinical and scientific instruments used for clinical testing. 8.0 RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in enough detail to allow NCI to determine if the party can perform the requirement. All responses must be submitted via email to Adam Hernandez, Contracting Officer at adam.hernandez@nih.gov. Responses are due no later than 3:00 P.M. ET Friday, April 02, 2021 (04/02/2021). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. To receive an award, Contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov, and have Representations and Certifications filled out. Reference 75N91021Q00057 on all correspondence.