Maintenance Agreement for GE MR Spinlab Hyperpolarizer
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Bethesda, MD 20892, UNITED STATES. Non-USPS mail s... Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. The Radiation Oncology Branch (RBB) of the Center for Cancer Research (CCR), National Cancer Institute (NCI) requests to procure a service contract to maintain and repair a Government-owned GE MR Spinlab Hyperpolarizer. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation includes all applicable provisions and clauses in effect through FAR FAC 2005-99 (July 2018) simplified procedures for commercial items. The North American Industry Classification System code is 811210 and the business size standard is $34 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract with a 12 month base period and four 12 month option periods. BACKGROUND The Radiation Biology Branch research activities are focused on pre-clinical basic science research aimed at identifying and incorporating novel approaches to cancer treatment, evaluation, and prevention. A variety of approaches are evaluated at the molecular, biochemical, cellular, and physiological levels including the impact of the tumor microenvironment and metabolic mutations to improve cancer treatment. Intentional or accidental exposure of humans to ionizing radiation or a course of definitive radiation therapy can lead to cancer induction or second malignancies. Research studies are directed to identify interventions to delay or prevent radiation-induced cancer after the exposure has occurred. Emphasis is placed on gaining a better understanding of the mechanisms of cell killing and protection and the activation/inhibition of complex signaling pathways mediated by oxidative stress, including ionizing radiation, reactive oxygen species (ROS), and reactive nitrogen species (RNS). A variety of cancer treatment modalities including ionizing radiation, cytotoxic and non-cytotoxic drugs, combinations of drugs and radiation, various enzymatic inhibitors, antioxidants, and a variety of agents that impose oxidative stress are used to reduce tumor growth, enhance the radiosensitivity of tumors, protect normal tissues against radiation damage, or decrease metastatic phenotypes. Additionally, chronic inflammation within the tumor microenvironment or within radiation-damaged normal tissues can result in generation of ROS and RNS and means of inhibiting inflammation by use of inhibitors of inducible nitric oxide synthase (iNOS), COX-2 inhibitors, and nitroxide antioxidants are being investigated. Novel functional imaging approaches including non-invasive measusement of tissue oxygen concentration and metabolism as measured by C13-pyruvate are being implemented as a means of improving cancer diagnosis, guiding individualized therapies, and temporal assessment of treatment response. The development, testing, refinement, and application of low-frequency electron paramagnetic resonance (EPR) functional imaging devices suitable for in vivo imaging of paramagnetic species has resulted in a prototype scanner for small animals that non-invasively measures tissue oxygen concentration. The ability to acquire multiple images over time is a unique feature of this novel imaging technology permitting monitoring physiological changes in the tumor in response to therapy. Pre-clinical metabolic imaging using hyperpolarized metabolic substrates is also being developed to access tumor response following various cancer treatment modalities as well as metabolically directed inhibitors. The Radiation Biology Branch (RBB) has been conducting pre-clinical and clinical research profiling renal cell cancers using metabolic MRI and using this information to plan treatments using appropriate regimens. The metabolic MRI studies involve preparing 13C labeled metabolic tracers such as pyruvate, fumarate by hyperpolarization and injecting them in the subjects and following the breakdown products using 13C MRI. Currently, RBB uses SPINLAB hyperpolarizer from GE to prepare the hyperpolarized tracers for pre-clinical and clinical research. The SPINLAB hyperpolarizer is Government-Owned and was acquired in 2013, and installed adjacent to MR scanners in RBB. The routine use for pre-clinical and clinical applications will be facilitated by having routine maintenance. OBJECTIVE The RBB of the Center for Cancer Research (CCR), National Cancer Institute (NCI) requests to enter into a service contract for preventative maintenance for a Government-owned GE MR Spinlab Hyperpolarizer System. SCOPE The Contractor shall provide all labor, material, and equipment necessary to maintain and provide preventive maintenance for the Government-owned GE MR Spinlab Hyperpolarizer. All hardware maintenance/upgrades shall be performed on-site in accordance with the manufacturer's standard commercial maintenance practices. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS The Contractor shall perform two (2) planned preventive maintenances during the contract period. Technically qualified factory-trained personnel shall perform the required services; The services shall consist of a thorough cleaning, calibration, adjusting, inspection, and testing of all 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. EMERGENCY SERVICE An on-site, emergency repair service visit shall be provided during the term of this contract at no additional cost to the government. Emergency service shall be provided during normal working hours, Monday through Friday excluding Federal Holidays. Upon receipt of notice that any part of the equipment is not functioning properly the Contractor shall provide a qualified factory-trained service representative on-site within 24 hours to inspect the equipment and perform all repairs and adjustments necessary to restore the equipment to normal and efficient operating condition. Emergency service calls shall not replace the necessity for planned preventative maintenance. All labor and travel shall be included. 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 new to original equipment specifications. Parts will be delivered the earliest next business day. SOFTWARE UPDATES/SERVICE The Contractor shall provide Software Service and updates in accordance with the manufacturer's latest established service procedures, to include telephone access to technical support for use of program software and troubleshooting 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. The Contractor shall provide unlimited clinical technical telephone support (Monday- Friday, 8am - 5pm EST, excluding Federal holidays) for trouble-shooting for the instrument. Onsite response time is within 24 hours. 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 contract. TYPE OF ORDER This is a severable firm fixed price purchase order. PERIOD OF PERFORMANCE Base Period: September 1, 2023 - August 30, 2024 Option Period One: September 1, 2024 - August 30, 2025 Option Period Two: September 1, 2025 - August 30, 2026 Option Period Three: September 1 , 2026 - August 30. 2027 Option Period Four: September 1, 2027 - August 30, 2028 PLACE OF PERFORMANCE NIH, NCI, 10 Center Drive 10/B3B401 Bethesda, MD 20892 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE • The Contractor shall perform two (2) planned preventive maintenances during the contract period. • 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. PAYMENT Payment shall be made after delivery and acceptance of the Technical Point of Contact. Payment authorization requires submission and approval of invoice to the NCI COR and NIH Commercial Accounts. PROVISIONS AND CLAUSES The following FAR provisions and clauses apply to this acquisition: 52.212-1 Instructions to Offerors Commercial Items (January 2017); 52.212-2 Evaluation Commercial Items (NOV 2021): (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: 1. Technical Approach 2. Personnel Requirements and Organizational Experience 3. Past Performance 4. Price Technical Approach and Personnel Requirements and Organizational Experience, when combined, are significantly more important than price; (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (DEC 2022) WITH DUNS NUMBER ADDENDUM {52.204-6 (OCT 2016)}; FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (DEC 2022); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (JUN 2023). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; FAR Clause 52.203-6, Restrictions on Subcontractor Sales to the Government FAR Clause 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters FAR Clause 52.219-14, Limitations on Subcontracting FAR Clause 52.222-3 Convict Labor FAR Clause 52.222-19 Child Labor - Cooperation with Authorities and Remedies FAR Clause 52.222-21 Prohibition of Segregated Facilities FAR Clause 52.222-26 Equal Opportunity FAR Clause 52.222-35, Equal Opportunity for Veterans FAR Clause 52.222-36, Equal Opportunity for Workers with Disabilities FAR Clause 52.222-37, Employment Reports on Veterans FAR Clause 52.222-40, Notification of Employee Rights Under the National Labor Relations Act FAR Clause 52.222-50, Combating Trafficking in Persons FAR Clause 52.222-54, Employment Eligibility Verification FAR Clause 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases FAR Clause 52.232-33 Payment by Electronic Funds Transfer-System for Awards Management (SAM) Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://ncioa.cancer.gov/oa-internet/ or from Miguel Diaz, Contracting Officer, at miguel.diaz@nih.gov OFFERORS: Offers must be submitted with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of the valid SAM registration through www.sam.gov. QUESTIONS ARE DUE: July 18, 2023 at 3:00pm EST Quotations must be received in the NCI-OA contracting office by 12:00 p.m. EST on July 21, 2023. Please refer to solicitation number 75N91023Q6585087 on all correspondence. Faxed quotations will NOT be accepted. Quotations shall be submitted via email to Miguel Diaz, Contracting Officer, at miguel.diaz@nih.gov . No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through sam.gov. BASIS FOR AWARD: Selection of an offeror for award will be based on an evaluation of proposals against four factors. The factors, in order of importance are: Technical Approach , Personnel Requirements and Organizational Experience, Past Performance and Price, All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. However, cost/price may become a critical factor in source selection in the event that two or more offerors are determined to be essentially equal following the evaluation of all factors other than cost/price. The process described in FAR 15.101-1 may be employed, which permits the Government to make tradeoffs among cost or price and non-cost factors to consider award to other than the lowest price offer or other than the highest technically rated factor. The Government intends to make an award to the offeror whose proposals provide the best overall value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs set forth in the Combined Synopsis/Solicitation. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the Combined Synopsis/Solicitation. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed below. The Evaluation Process: The Government will award a contract resulting from this quotation to the responsible contractor whose quote conforming to the quotation will be the most advantageous to the Government, price and other factors considered. The following evaluation factors shall be used to evaluate the prospective contractors and are listed in order of importance. 1. Technical Approach (60) 2. Personnel Requirements and Organizational Experience (40) 3. Past Performance (evaluated, but not scored) 4. Price (evaluated, but not scored.) TECHNICAL EVALUATION CRITERIA: 1. Technical Approach: (60 points): • The Offeror will be evaluated by the quality and reasonableness of the proposed technical plan as evidence of understanding of the scope, purpose, and complexity of the requirements as described in the Statement of Work (SOW) in enough detail that someone with a rudimentary knowledge of the subject would be able to understand the offeror's ability to perform the work. The proposed technical plan shall demonstrate the following: o Must show evidence that previous work performed from at least two (2) past clients with GE Healthcare MR SPINlab Hyperpolarizer meets the standards of the government-owned GE Healthcare MR SPINlab Hyperpolarizer. o Must show interaction with GE Healthcare service engineers and knowledge of the interface between these instruments. o Ability to demonstrate email and telephone technical expertise on troubleshooting GE MR SPINlab Hyperpolarizer. o Ability to perform software service and updates in accordance with the manufacturer's established service procedures. 2. Personnel Requirements and Organizational Experience: (40 Points): • The Offeror will be evaluated by the appropriateness and adequacy of the proposed project personnel and organization experience as it relates to the completion of the requirements in the Statement of Work, including the responsibilities and level of effort for all personnel who will be assigned to the contract. Staff as well as their detailed qualifications must be described. The key personnel assigned to this contract shall include: Field Service Representatives and Certified Service Engineers. The contractor shall provide a copy of the certificate of key personnel that will be performing the work stated in the SOW. Contractor shall also include the following in the quote/proposal: o Demonstrate knowledge and expertise on servicing and troubleshooting the same or similar instruments as listed on the Statement of Work (SOW). o Demonstrate completion of certification for end-to-end system maintenance and repair (including both hardware and software) o Demonstrate the ability to have on-site response capabilities within 24 hours since initial call by customer through the number of available, certified service engineers staffed in the company. Offerors shall submit the following information as part of their response: • A list of the two (2) contracts providing similar products or services working onsite at the clients facility containing a GE MR SPINlab Hyperpolarizer completed during the past ten years and all contracts currently in process that are similar in nature to the solicitation. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Quoters/Offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. The list of contracts is preferably related to past experience with GE MR SPINlab Hyperpolarizer as experience with other instruments may be irrelevant. Include the following information for each contract or subcontract: 1. Name of Contracting Organization 2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's and Telephone Number 8. Standard Industrial Code o The quoter/offeror must provide specific information on problems with GE Healthcare MR SPINlab Hyperpolarizer encountered on the identified contracts and the quoter's/offeror's corrective actions. Each quoter/offeror may be evaluated on their performance under existing and prior contracts for similar products or services. The Government is not required to contact all references provided by the quoter/offeror. Also, references other than those identified by the quoter/offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the quoter/offeror's organizational experience. The Government may evaluate the offeror's past performance on organizational experience based on information obtained from references provided by the offeror, other relevant past performance on organizational experience information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by thatofferor's record of past performance.
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