Description: The Hematology Branch (HB) in the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), is involved in the study of somatic mutations in patients with bone marrow failure. It has a number of NIH Internal Review Board (IRB)-approved clinical protocols focused on somatic mutations in patients that require targeted sequencing for recurrent mutations in myeloid neoplasms. These protocols cover a wide range of targeted sequencing including: chromosomal analysis/cytogenetics techniques such as karyotyping and fluorescent in situ hybridization (FISH); bone marrow aspiration and biopsy for morphology; CLL panels; additional cytogenetics (i.e. morphology, cellularity, percentage of blast cells, and chromosomal analysis by PCR); in vitro colony growth; flow cytometry; and RNA or DNA analysis. Due to the high volume of patients received under the HB's IRB-approved clinical protocols and the vast array of testing required for each patient, the HB is unequipped to perform its diagnostic testing in-house. It, therefore, needs to outsource its testing to a CLIA-certified contractor capable of conducting a large quantity of tests in a short period of time. The contractor shall utilize NGS myeloid panels for each test, and may be required to conduct multiple tests using one panel. (i) This is a combined synopsis/solicitation for commercial items / services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. (ii) The solicitation number is NHLBI-CSB-HL-2016-194-JML and the solicitation is issued as a request for quote (RFQ). (iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89-1 effective August 15, 2016. (iv) The associated NAICS code is 541380, Testing Laboratories, and the small business size standard is $15.0M. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.5. (v) The contractor requirements are as follows: The Hematology Branch (HB) will send clinical samples to the contractor along with instructions on which tests to conduct on each sample (the contractor shall absorb all shipping costs). The contractor will conduct the following tests within a timeframe mutually agreed to by both parties at the time of request: ? 54 Gene Myeloid Panel by Next Generation Sequencing ? Cytogenetics ? NeoArray SNP/Cytogenetic Profile ? 7q Del (MDS) ? BTK Inhibitor acquired resistance panel ? IgVH Mutation analysis ? MYD88 Mutation analysis ? CLL FISH ? Multiple Myeloma FISH (lgH Complex) ? MDS FISH ? PML RARA t(15;17) PCR ? BCR-ABL by PCR (plasma based; includes log reduction and IS; p190 and p210 included) ? T-Cell Gene Rearrangement ? B Cell Lymphoma (High grade, Large B-Cell Lymphoma) ? Fanconi Anemia Panel ? Parovirus ? TP53 Mutation Sequencing (vi) Period of Performance: Base Year: October 1, 2016 - September 30, 2017 Option Year 1: October 1, 2017 - September 30, 2018 Option Year 2: October 1, 2018 - September 30, 2019 (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, is applicable. 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. The following factors shall be used to evaluate offers: Contract award shall be made to the responsible Offeror whose offer, in conforming to this RFQ, provides the overall best value to the Government, technical, past performance, and cost evaluation factors considered. The Government's objective is to obtain the highest technical quality considered necessary to achieve the project objectives, with a realistic and reasonable cost. Technical and Past Performance evaluation factors are more important than cost. Total points: 100 1. Technical Capability (60 points) The contractor is capable of performing the tests referenced above, including Next Generation Sequencing (NGS) panel for targeted genes to evaluate myeloid disorders according to CLIA standards. 2. Timeliness (30 points) The contractor must demonstrate its ability to execute the tests listed above in a timely manner and provide evidence of that ability. 3. Past Performance (10 points) The contractor shall provide customer surveys or other applicable past performance questionnaires demonstrating work performed relating to the required tasks and services. A list of purchase orders and/or contracts providing for services over the past three (3) years may be provided if no applicable surveys or questionnaires are obtainable. If no past performance documents are provided, the Contracting Officer will base the past performance score on the Contracting Officer's knowledge of, and previous experience with, the supply or service being acquired. (x) FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision. (xi) FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. Including the following clauses and Prohibitions: i. 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations 52.219-28, Post Award Small Business Program Representation ii. 52.233-3, Protest After Award iii. 52.233-4, Applicable Law for Breach of Contract Claim iv. 52.222-3, Convict Labor v. 52.222-21, Prohibition of Segregated Facilities vi. 52.222-26, Equal Opportunity vii. 52.222-36, Equal Opportunity for Workers with Disabilities viii. 52.222-50 Combating Trafficking in Persons ix. 52.225-13, Restrictions on Certain Foreign Purchases x. 52.232-33, Payment by Electronic Funds Transfer-System for Award Management xi. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving xii. 52.244-6, Subcontracts for Commercial Items xiii. 52.2232-39, Unenforceability of Unauthorized Obligations (xiii) All responses must be received by September 28, 2016 at 9:00 AM and must reference number NHLBI-CSB-HL-2016-194-JML. Responses may be submitted electronically to
contact@example.gov or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, MD 20892-7902, Attention: Jonathan M. Lear. Phone:
+1 (555) 000-0000; Faxed responses will not be accepted.
