Standard Reference Material (SRM) 965c, 967b, and 1955a

DESCRIPTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in the Federal Acquisition Regulation (FAR) Subpart 12.6 - Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is being issued using Simplified Acquisition Procedures under the authority of FAR Parts 12 and 13. Simplified Acquisition Procedures will be utilized. This solicitation is a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-05 effective March 10, 2021. The associated North American Industrial Classification System (NAICS) code for this procurement is 325413 - InVitro Diagnostic Substance Manufacturing. The small business size standard is 1,250 employees. This acquisition is being procured 100% set-aside for small business. The non-manufacturer rule applies to this procurement. Quoters must provide the product of a small business. Reference the FAR Clause 52.219-33 Nonmanufacturer Rule. The National Institute of Standards and Technology (NIST) has provided batches of Standard Reference Material (SRM) 965 Glucose in Frozen Human Serum since 1996 and SRM 967 Creatinine in Frozen Human Serum since 2007. Both batches of SRMs are expected to be out of stock within approximately three years. In addition, NIST began selling SRM 1955 Homocysteine and Folate in Human Serum in 2005. SRM 1955 has recently sold out, and a new material, SRM 3949 Folate Vitamers in Frozen Human Serum, is planned to replace the material for folates. To continue support of measurements of in vitro diagnostics, reference laboratories, and clinical laboratories, the Chemical Sciences Division (CSD) requires creatine and glucose in human serum SRMs 967b and 965c. Furthermore, to address further research for a multi-level homocysteine material, a new batch of SRM 1955 must be acquired; Pooled human serum shall be utilized. Responsible quoters shall provide a firm fixed, FOB Destination price for one or more of the following line items: Line Item 0001: Firm-Fixed Price - One (1) Lot of 8,000 vials of SRM 967b, produced in accordance with the attached statement of work. Line Item 0002: Firm-Fixed Price - One (1) Lot of 24,000 ampoules of SRM 965c, produced in accordance with the attached statement of work. Line Item 0003: Firm-Fixed Price - One (1) Lot of 4,500 vials of SRM 1955a, produced in accordance with the attached statement of work. DELIVERY The SRMs must be delivered within 180 days after the date of award. Reference the statement of work for delivery requirements and required notifications. Ship to Address: National Institute of Standards and Technology (NIST) 100 Bureau Drive Building 301 Attention: 227/B146 Gaithersburg, Maryland 20899-0001 FOB Destination delivery terms are required. FOB DESTINATION MEANS: The Contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. EVALUATION CRITERIA AND BASIS FOR AWARD The Government intends to award one or more purchase orders, resulting from this solicitation, to responsible Contractor(s) whose quotation(s), conforming to the solicitation, will provide the best value to the Government, price and other factors considered. The Government reserves the right to make multiple awards if it is determined to be in the Government's best interest to do so. Quoters may provide multiple quotations, at their decision and discretion, if quoting on more than one statement of work. The following factors shall be used to evaluate quotations: Technical Approach Experience Past Performance Price Technical Approach, Experience and Past Performance shall be equal in importance to each other. When combined, technical approach, experience and past performance shall be equal in importance to price. As the quality and merit of quotations become more equivalent among quoters, price shall become more of a determining factor. Technical Approach: Technical approach will be evaluated to confirm that the quoter possesses a valid ISO certification, specifically, 13485:2016 - Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes, determine the extent to which the Contractor's proposed approach clearly demonstrates their ability to satisfy all requirements of the Statement of Work for which the quotation is provided, will ensure the on-time delivery of the quoted SRM(s), and that the quoter possesses or has access to the facilities necessary to produce the SRM(s). Experience: The quotation will be evaluated to determine that the quoter meets all minimum Contractor requirements identified in the statement of work for which the quotation is provided and to determine the depth and breadth of experience the Contractor, including proposed subcontractors, possess analyzing the compounds in human serum relevant to the SRM(s) being quoted. Past Performance: Evaluation of past performance shall be based on the references provided and/or the Contractor's recent and relevant procurement history with NIST or its affiliates. Past Performance will be evaluated to determine the overall quality of the product and service provided by the Contractor. In the case of a Contractor without a record of relevant past performance, the Contractor will receive a neutral rating. Price: Price shall be evaluated for all quoters whose quotations are determined technically acceptable. Price will be evaluated to determine that the proposed price is consistent with the technical portion of the quotation and is an overall fair and reasonable price to the Government. REQUIRED SUBMISSIONS All contractors shall submit the following: TECHNICAL QUOTATION: 1. For the purpose of evaluation of Technical Capability, the quotation must include: -Documentation which clearly shows that the quoter possesses a current certification for ISO 13485:2016 - Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes, in accordance with each SOW. -A description of the facilities, including cold storage facilities, the Contractor possesses or has access to that will be used throughout the production process. -A technical approach for each SRM being quoted. At a minimum, the technical approach shall include: A list of steps that the quoter will take to produce the SRM; A discussion, in the quoter's own words, of the CLSI process; Documentation of how the quoter will maintain compliance with the Common Rule for the Protection of Human Subjects (15 C.F.R. Part 27) relevant to the quoter's proposed approach to producing the SRM; and A discussion of perceived risks associated with the required work and how the quoter will mitigate these risks. -If the quoter is utilizing a subcontractor for any work, the same information must be provided for the subcontractor relevant to the work the subcontractor will perform. 2. For the purpose of evaluation of Experience, the quotation must include: -Documentation that clearly demonstrates the Contractor meets the minimum qualifications identified in the statement of work; -Project descriptions, products with specifications, publications, research papers, or other documentation, which clearly demonstrate the quoter's experience analyzing the compounds in human serum relevant to the SRM being quoted. 3. For the purpose of evaluation of Past Performance, the quotation must include: - Past Performance information regarding relevant contracts over the past three (3) years with Federal, state, or local governments, or commercial customers. -If the quoter intends to subcontract with another firm(s) for any part of this requirement, that firm's past performance reference information shall also be provided. If the quoter has no relevant past performance, it shall include a statement to that effect in its quotation. -The Government reserves the right to consider data obtained from sources other than those described by the quoter in its quotation. -The description of each contract described in this section shall not exceed one-half page in length. -For each contract, the quoter shall provide the following information: Contract number; Description and relevance to solicitation requirements include dollar value; Period of Performance - indicate by month and year the state and completion (or - ongoing) dates for the contract; Reference Contact - If a non-Government contract, identify the name and address of the client with current telephone number and email address of a point of contact of the client responsible for the contract; Contracting Office - If a Government contract (Federal or state), identify the Procuring Contracting Officer (PCO), Administrative Contracting Officer (ACO), and Contracting Officer's Representative (COR), and their names, current telephone numbers and email addresses; and Problems Encountered - include information regarding information regarding any problems encountered on the contracts described above and corrective actions taken to resolve those problems. PRICE QUOTATION -The Contractor shall provide a firm fixed price for each line item being quoted. The price must be inclusive of all costs to complete all work required by the statement of work for each line item. -The Contractor, including all proposed subcontractors, shall include pricing for each of the following, as appropriate, at a minimum: Labor, materials, travel, subcontractors, consultants, other direct costs, indirect costs. -The Contractor must have the financial capacity, working capital and other resources to perform work under the resultant contract. -The Government anticipates that the contract will be awarded based upon adequate price competition. However, in order to determine that prices are fair and reasonable, the Government reserves the right to request the quoter provide further cost breakdown to support proposed prices. -If multiple awards are contemplated by the Government, price will be evaluated inclusive of a fixed amount of $500, which represents the cost associated with administration of multiple awards vs. a single award. -The Service Contract Labor Standards (formerly Service Contract Act) does not cover bona fide executive, administrative, or professional employees. If Contractor employees performing under this requirement fall within this exemption, offerors must state the applicable exemption. Reference Fact Sheet 17a at http://www.dol.gov/whd/regs/compliance/fairpay/fs17a. TERMS AND CONDITIONS Contractors must provide a statement that they concur with all terms and conditions of the solicitation without change, addition, deletion or exception. Any exceptions must be clearly documented. If the Contractor objects to any of the terms and conditions contained in this solicitation, the Contractor shall state "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" [Contractor shall list exception(s) and rationale for the exception(s)]. It is the sole responsibility of the contractor to identify in their quote any exceptions to the terms and conditions of the solicitation. If the contractor does not include such a statement, the submission of a quotation in response to this solicitation will be regarded as the Contractor's acceptance of the Government's terms and conditions for inclusion into the resultant purchase order. CONTRACTOR IDENTIFYING INFORMATION The Contractor must provide a DUNS # for their active System for Award Management (SAM) registration. Quoters must have an active registration at www.SAM.Gov to be considered for award. If the quoter's representations and certifications do not reflect the NAICS code governing this solicitation, quoters must submit documentation of their business size under the NAICS code governing this solicitation. Please note that this procurement IS NOT being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If a Contractor submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Purchase Order, not the terms and conditions of the Contractor's FSS or GWAC contract, and the statement required above shall be included in the quotation. DUE DATE FOR QUOTATIONS All quotations must be submitted via e-mail to Sadaf Afkhami, Contract Specialist at contact@example.gov. FAX quotations will not be accepted. Submission must be received not later than 1:00 p.m. Eastern Standard Time on May 27, 2021. A quotation shall be considered received when it is received in the electronic inbox of Sadaf Afkhami not later than the date and time identified herein. All questions regarding this notice must be submitted via e-mail to contact@example.gov by 1:00 p.m. Eastern Standard Time on May 18, 2021. Questions submitted after this date may not be addressed by the Government prior to the quotation submission deadline.