Human Serums SRM

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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 13.5 Simplified Acquisition Procedures. This solicitation is a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect trough Federal Acquisition Circular 2019-02, effective May 6, 2019. 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 utilizing Total Small Business Set-Aside procedures. The National Institute of Standards and Technology (NIST) has provided batches of SRM 967 Creatinine in Frozen Human Serum since 2007 and SRM 965 Glucose since 1996. These materials support the measurements of in vitro diagnostics manufacturers, reference laboratories, and clinical laboratories in the United States and globally. 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. However, there is still a need for a multi-level homocysteine material which, is not supported by the new SRM 3949. To continue support of measurements of in vitro diagnostics, reference laboratories, and clinical laboratories, the Chemical Sciences division (CSD) is requesting creatine and glucose in human serum SRMs 967b and 965c. Furthermore, to address further research for a multi-level homocysteine material, the division will need to create a new batch of SRM 1955, by utilizing pooled human serum. NIST intends to issue one or multiple purchase order awards as a result of this solicitation. SPECIFIC REQUIREMENTS The contractor shall perform the requirements identified in the attached Statements of Work. Responsible quoters shall provide pricing for one, two, or each of the following line items (CLINs): 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. The items shall be delivered FOB Destination: The National Institute of Standards and Technology (NIST) 100 Bureau Drive Building 301 Attention: 227/B146 Gaithersburg, Maryland 20899-0001 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 Award shall be made to the Contractor that provides the lowest priced, technically acceptable quote for each Contract Line Item (CLIN) which conforms to the solicitation requirements (see Required Submissions section). NIST is utilizing a streamlined solicitation to procure various Human Serum, potentially resulting in multiple purchase order awards. CLINs 0001, 0002, and 0003 are separate procurements. The requirements are being streamlined into one solicitation for the sake of efficiency, and to minimize administrative burdens however, each CLIN should be regarded as a distinct requirement for the purposes of quote submission. A contractor may bid on one, some, or all the CLINs at their discretion. If the same vendor is selected for award of multiple CLINs, NIST may elect to consolidate the successful quotes into one purchase order, again to minimize administrative burdens. NIST will award each of the CLINS contained in this solicitation to the lowest priced, technically acceptable quote for that particular CLIN. Technical acceptability means that the quote meets the stated minimum specifications and complies with the solicitation requirements. Technical Capability: Evaluation of Technical Capability shall be based on the information provided in the quotation. NIST will evaluate whether the Contractor has demonstrated that the offered product(s) meet the requirements of the Statement of Work(s). Contractors shall provide a quotation for 100% of the serum in a CLIN. To be considered technically acceptable for a CLIN, the contractor must provide a quotation for all serum associated with that CLIN. Price will be evaluated to determine that each CLIN is consistent with the technical portion of the quotation and is a fair and reasonable overall price to the Government. REQUIRED SUBMISSIONS All contractors shall submit the following: 1. Documentation demonstrating an understanding and ability to meet the Government's requirements, providing concise and detailed discussion of its intended approach for fulfilling the requirements defined in the Statement(s) of Work. Additionally, the contractor shall provide a current certification for ISO 13485:2003, "Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes" in accordance with each SOW. 2. Contractors shall provide a Firm-Fixed price quotation for CLIN0001 and/or, CLIN0002, and/or CLIN0003 to satisfy the requirements of each statement of work. 3. A complete version of all required solicitation provisions (see attached provisions/clauses document - required submissions highlighted in blue). 4. 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. 5. Quoters shall provide an active DUNS # for the System for Award Management (SAM) registration. Quoters must have an active registration at www.SAM.Gov to be considered for award. 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 E-mail quotations are required. All quotations must be submitted via e-mail to Tish Walker, Contract Specialist at contact@example.gov FAX quotations will not be accepted. Submission must be received not later than 5:00 p.m. Eastern Time on Friday May 24, 2019. A quotation shall be considered received when it is received in the electronic inbox of Tish Walker 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 12:00 p.m. Eastern Time on Friday May 17, 2019. Questions submitted after this date may not be addressed by the Government prior to the quotation submission deadline. PAYMENT The Contractor may invoice the Government upon notification from the Technical Point of Contact (TPOC) that a given deliverable is of acceptable quality; however, the contractor shall not submit in total more than ten (10) invoices.