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), Surgery Branch (SB) intends to procure, ... The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) intends to procure, on a sole source basis, preventive maintenance, emergency service, support, and coverage for a Government-owned I-DOT One Dispensing System (S/N: I2-211089) from Cellink LLC, 2000 Kraft Dr., Suite 2125, Blacksburg, Virginia 24060-2578. 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 (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Surgery Branch (SB) is a combined laboratory and clinical research unit devoted to the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer. The highly personalized immunotherapies used to treat late-stage cancer patients routinely require the identification of tumor reactive T-Cell Receptors (TCRs) from patient samples. To identify these sequences, SB have implemented a single-cell NGS method. Single-cell sequencing is required to determine the correct pairing of the alpha and beta chains of this heterodimeric receptor. Single-cell sequencing approaches use smaller reagent volumes which makes them more sensitive to errors in pipetting, more prone to issues of cross-contamination, requires processing more samples at a time, and in the case of TCR sequencing, uses RNA as the starting material which makes the setting-up process more susceptible to experimental nuances. The use of the I-DOT One non-contact low-volume liquid dispensing system enables SB to process plates more quickly, without contact, and more accurately. For uninterrupted processing of these important NGS libraries, SB requires the procurement of preventive maintenance, emergency service, support, and coverage of the Government-owned I-DOT One system. 2.0 SCOPE The Contractor shall provide all labor, material, and equipment necessary to maintain and provide preventive maintenance for the I-DOT One dispensing system (S/N: I2-211089). All travel, labor and related charges shall be included at no additional expense to the Government. All maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturer’s (OEM) most current standard commercial maintenance practices. The Contractor shall provide unlimited technical and clinical application support. 3.0 CONTRACTOR REQUIREMENTS AND PERSONNEL QUALIFICATIONS 3.1 PREVENTIVE MAINTENANCE The Contractor shall perform one (1) planned preventive maintenances during each period of performance outlined in section 6.0. Technically qualified factory-trained personnel shall perform the service. The service shall consist of a thorough cleaning, calibration, adjusting, inspection, and testing of all equipment in accordance with the OEM’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 guarantee optimum and efficient performance. 3.2 EMERGENCY SERVICE On-site, emergency repair service visits shall be provided during the term of this Purchase Order at no additional cost to the government. Emergency service shall be provided during normal working 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). Upon receipt of notice 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 48 hours on-site to inspect the malfunctioning equipment and perform all repairs and adjustments necessary to restore the 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. All parts shall be new to original equipment specifications. If the parts are in stock, the Government expects delivery and any on-site installation to be the next business day. If parts are unable to be provided the next business day, the Contractor shall notify the TPOC via email stating the reason and estimated delivery timeframe immediately upon identification of delivery delay. 3.4 SOFTWARE UPDATES / SUPPORT SERVICES The Contractor shall provide software service and updates (including firmware), in accordance with the manufacturer’s latest established service procedures. 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. The Contractor shall provide unlimited clinical technical and application support normal working 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) for use of program software and trouble shooting of the operating systems. All technical and application support shall be available via telephone and email. 3.5 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. 3.6 PERSONNEL QUALIFICATIONS Technically qualified, OEM-trained service technicians shall perform all required services. The technicians shall be specifically trained and have sufficient experience on the I-DOT One dispensing system to carry out maintenance services covered under this Purchase Order. Technicians shall maintain full access to official instrument documentation and software resources. All primary service personnel shall have at least one backup support person with at least the same level of training and experience. 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 anticipated period of performance shall be for twelve (12) months plus four (4) twelve-month option periods as follows: Base Period: 06/01/2022 – 05/31/2023 Option Period 1: 06/01/2023 – 05/31/2024 Option Period 2: 06/01/2024 – 05/31/2025 Option Period 3: 06/01/2025 – 05/31/2026 Option Period 4: 06/01/2026 – 05/31/2027 6.0 PLACE OF PERFORMANCE Onsite services shall be performed at the following location: NIH, NCI, 10 Center Dr Bldg. 10 CRC Rm. 3-3857 W Bethesda, MD 20892 7.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR The Government-Owned I-DOT One Dispensing System (S/N: I2-211089) must be calibrated accurately and maintained according to the manufacturer’s specifications by authorized Original Equipment Manufacturer (OEM) personnel. The system utilizes highly specialized and proprietary technology to precisely generate 8-50nl droplets through 8 individually controlled positive pressure channels. Droplets are generated at up to 100 droplets per second per channel, meaning 10nl can be distributed across a 96 well plate in 10 seconds. The SB uses the system for the dispense of reagents at low volume that are critically important for the synthesis of cDNA from RNA and so the speed, accuracy, and reproducibility that the system provides is extremely important. Therefore, the system needs to be maintained and, in the event of any technical issues, repaired as soon as possible. To the knowledge of the SB, CELLINK LLC is the original manufacturer, distributor, and the sole provider of preventive maintenance services, emergency service, proprietary firmware maintenance/upgrades, genuine OEM parts, and OEM trained technical support for trouble shooting and diagnosing issues that arise during regular operation of the instrument. The required services on this complex and proprietary technology instrument are not authorized through any other entity. 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 29, 2022 (04/29/2022). 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 75N91022Q00069 on all correspondence.