Ultra-High-Performance Liquid Chromatograph (UHPLC) for San Juan Laboratory and Pacific Southwest Medical Products Laboratory for the Food and Drug Administration, (FDA)

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation, and a written solicitation will not be issued. - Brand Name or Equal product only. The following FAR Clause applies: Clause 52.211-6 - Brand Name or Equal (AUG 1999) This requirement is - Subject to the Availability of Funds The Following FAR Clause applies: AVAILABILITY OF FUNDS (52.232-18) (APR 1984) This synopsis, NAICS code 334516, identified as FDA-125530 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. Ultra-High-Performance Liquid Chromatograph (UHPLC) for San Juan Laboratory and Pacific Southwest Medical Products Laboratory for the Food and Drug Administration, (FDA) Background The U.S. FDA San Juan Laboratory (SJNL) and Pacific Southwest Medical Products Laboratory (PSMPL) need to replace existing HPLC systems used for routine HPLC sample analysis. The systems in use need to maintain cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The systems are used to screen and analyze medical product samples using specific protocols and methods established by USP, internal FDA, DOD SLEP, and the FCC program. As a Medical Product Specialty Laboratory, the laboratories use HPLC technology to analyze a variety of drug samples. The FDA laboratories needs to update the existing HPLCs to a new UHPLC systems with modern HPLC/UPLC capabilities. Specifically, replacing the older broken chromatographic HPLC systems with a new, workgroup/enterprise compatible, UHPLCs with high pressure, quaternary solvent gradient, and temperature-controlled capabilities. The new UHPLCs can achieve higher resolution with improved chromatographic separations, faster analyses, and sophisticated data analysis and reporting, while achieving lower cost operations, with fast analysis and reporting, less solvent consumption, and electrical demand. Scope/Requirements/Deliverables The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). Two UHPLC systems with HPLC/UPLC capabilities with scanning photodiode array detectors. Minimum Salient Characteristic & Performance Requirements All the following system requirements are minimum requirements The UHPLCs shall comply with the following requirements: ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html ISO 9001:2008 https://www.iso.org/standard/46486.html 21 CFR Part 11 Compliance https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin Instrument Controller Firmware, Drivers, and Updates must be Compatible with the current enterprise system, software, drivers, and updates. Specifically, Empower 3.6.1 Enterprise. Flow range up to 5 mL/min Flow accuracy and precision meet requirements above in section 2a Pressure Range up to 9,500 psi A minimum of four eluent lines Solvent degassing built in for all eluent lines Injection volume up to 50 - L with optional injection volume up to 1000 - L available Injection volume accuracy and precision meet requirements in section 2a Linearity: Corr. Coefficient and Carry Over meet requirements in Section 2a Sample compartment temperature range at least 5'40 - C Column Compartment Temperature range: 20 - C to 90 - C Sample and Column Compartment Temperature accuracy meet requirements in 2a Column Compartment Temperature stability/precision meet requirements in 2a Column Tracing and Audit Trail capabilities Integrated Vacuum Degassing Low dispersion Flow Cell Photodiode Array Detector Wavelength Range covers the ultraviolet and visible spectra range Detector Noise and Drift meet requirements in section 2a Installation, instrument configuration, and set up to the existing Empower Enterprise Installation and Operational Qualification Training for 3-5 users Trade and Service Specs Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. The Contractor shall provide a minimum of a one-year manufacturing warranty for all manufactured equipment and parts. The warranty shall be included with the equipment and not separately priced. The warranty shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. The supplier shall provide training and validation of the equipment and software on site at the time of installation. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided, such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by an FDA representative before installation of the equipment and execution of protocols. Inside delivery, disposing pallets, boxes, and any associated garbage, and unpacking the equipment and inventory of parts with a lab representative. Documentation Requirements Installation and Operational Qualification Documentation Certificates of Familiarization Training Instrument Manuals Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contract information of the technician who performed the repair/service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed). Deliverable Table/Period of Performance Deliverable Quantity Due Date UHPLC with PDa detector, firmware and drivers, package (Irvine, CA and San Juan, PR) 2 Within 6-8 weeks after date of award Installation and Operation Qualification documentation (Irvine, CA and San Juan, PR) 2 Within 6-8 weeks after date of award Certificates of Familiarization Training (Irvine, CA and San Juan, PR) 3-5 users at each location Within 6-8 weeks after date of award Instrument User Manuals (Irvine, CA and San Juan, PR) 2 Within 6-8 weeks after date of award Place of Performance Food and Drug Administration San Juan Laboratory 466 Fern'ndez Juncos Ave. San Juan, PR. 00901-3223 And Food and Drug Administration Pacific Southwest Medical Products Laboratory 19701 Fairchild Road Irvine, California, 92612 POCs: To be identified at time of award Vendor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below between the hours of 8:00 a.m. and 4:00 p.m. in accordance with the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery must be inside the facility. Period of Performance The period of performance is for 12 months from date of award which includes the 12- month Warranty Period. The Instrument to be delivered no later than 6-8 weeks after date of award. Inspection Acceptance All items specified under this order are subject to final inspection and acceptance by an authorized representative for the Government. The authorized representative of the Government is the Government's COR, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. Contracting Officer Authority The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds. The Contracting Officer's Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order. Contract Type Firm-Fixed-Price (FFP). All deliverables shall be clearly identified, complete with clear descriptions; due dates, and at a predetermined, agreed-upon price.. Government Contracts Contracting Officer: (CO): Office of Acquisitions Grants and Services Mary Rose A. Nicol, CO Phone: 240-402-7606 Email: Maryrose.nicol@fda.hhs.gov Contracting Office Representative (COR): TBD Government Holidays The Contractor is not required to provide on-site service on the following days that are Federal Holidays or on any other day designated as a Federal holiday, Government closure, or shut-down for the Washington, D.C. area: New Year's Day Martin Luther King Day President's Day Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veteran 's Day Thanksgiving Day Christmas Day SALIENT CHARACTERISTICS All the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. **Offerors shall address each of the salient characteristics in order to be considered.** BASIS OF AWARD The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed?price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non?cost factor (technical conformance to the requirements of the solicitation). The Quoter's initial quotation shall contain the Quoter's best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. FAR provisions can be found on the following website: http://Acquisition.gov The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are Registered in SAM.gov under NAICS code; 334516 delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA. FDA intends to make an award soon after the response date of this notice and all quotes must be submitted via email to Maryrose.nicol@fdahhs.gov and be received by 5:00 PM (1700) on May 18, 2022 to the attention of Mary Rose A. Nicol, maryrose.nicol@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. ALL QUESTIONS REGARDING THIS SYNOPSIS/SOLICIATION MUST BE SUBMITTED IN WRITING NO LATER THAN 5:00 PM (1700) EST May 16, 2022.FAX QUOTES SHALL NOT BE ACCEPTED.