Triage of HPV-Positive Women with p16/ki-67 Dual Stain cytology

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E226, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. 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: No. N02CP62616-24 includes all applicable provisions and clauses in effect through FAR FAC 2005-89 (July 2016) simplified procedures for commercial items. The North American Industry Classification System code is 541380 and the business size standard is 500 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. I. Description of Requirement Research over the past 20 years has identified human papillomaviruses (HPV) as the necessary cause of cervical cancer. About 13-15 carcinogenic types may cause cancer. However, HPV infections are very common among sexually active women and only a small subset progresses to cervical cancer. Recently, large randomized clinical trials have demonstrated that detection of carcinogenic HPV DNA can be used efficiently in primary screening to identify women at risk of cervical cancer. Due to its high sensitivity and high negative predictive value over a long period of time, primary HPV testing will allow extending screening intervals among women testing negative for HPV DNA. However, women with a positive HPV test result will require a secondary test, since the vast majority of women have only transient infections that do not require treatment. One promising assay to serve as a secondary test for HPV-positive women is cytological staining for p16/ki67. p16 staining combined with ki67 staining is a very specific indicator of high grade cervical intraepithelial neoplasia, the condition that is treated to prevent cervical cancer. NCI plans to conduct a large study to evaluate the performance of p16/ki67 triage of HPV-positive women. Purpose: The purpose is to stain cytology slides from 20,000 women enrolled in a NCI study on cervical cancer screening and triage using the p16/Ki-67 dual stain assay and return slides to the NCI biorepository. Contractor Requirements: 1. Perform p16/ki67 staining of 20,000 cytology slides. Slides will be sent to the contractor in weekly shipments at room temperature. Staining shall be performed within 3 days of receiving the slides according to the package insert of the CINtec assay. Staining shall be performed using the p16/Ki-67 dual stain assay CINtec Plus. Slides shall be labeled using the study IDs that will be provided with each shipment. 2. Ship slides to NCI repository At the end of the contract, stained slides shall be shipped to the NCI repository at room temperature. Reporting Requirements and Deliverables: The contractor shall provide a monthly report to the COR, summarizing how many batches and slides were stained during the month and whether there were any problems or incidents. Period of Performance - The period of performance shall be from September 1, 2016 until August 31, 2017. II. Deliverables: All stained slides shall be shipped to the NCI biorepository after completion of the contract. The COR will review delivered slides within one month and determine the acceptance. The Contractor that receives the award will be provided with the complete mailing address and point of contact. III. Payment: Payment shall be made after delivery and acceptance of the slides. NCI will have one month in which to review and accept the slides. If no comments or request for revisions are provided within one month, the deliverables shall be considered acceptable. Payment authorization requires submission and approval of invoice to the NCI COR and NIH Commercial Accounts. QUESTIONS ARE DUE: August 15, 2016 EVALUATION - BASIS FOR AWARD This acquisition will utilize the Lowest Priced Technically Acceptable (LPTA) procedure to make a best value award. A decision on the technical acceptability of each offeror's quotations will be made. For those offerors which are determined to be technically acceptable, award will be made to that vendor with the lowest overall price. While the Government will strive for maximum objectivity, the technical go/no go process, by its nature, is subjective; therefore, professional judgment is implicit throughout the evaluation process. The Government intends to make an award based on the initial quotations. If further questions are required, the contracting officer may contact the offeror or offerors. Award will be made to the responsible offeror whose quotation conforms to all solicitation requirements, such as terms and conditions, representations and certifications, technical requirements, and also provides the best value to the Government based on the results of the evaluation. PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (October 2015); FAR 52.212-2, EVALUATION - COMMERCIAL ITEMS (October 2014) FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (November 2015) WITH DUNS NUMBER ADDENDUM {52.204-6 (July 2013)}; FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (May 2015); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (November 2015). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; FAR Clause 52.204-10 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 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns FAR Clause 52.219-14 Limitations on Subcontracting FAR Clause 52.219-28 Post Award Small Business Program Representation 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 52.223-18 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 Kimesha Leake, Contract Specialist at contact@example.gov OFFERORS: Offers must be submitted on an SF-1449 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 certification registrations of the offeror's System for Award Management (SAM) and Online Representations and Certifications Applications (ORCA) through www.sam.gov. Quotations must be received in the NCI-OA contracting office by 12:00 pm EST on August 26, 2016. Please refer to solicitation number N02CP62616-24 on all correspondence. No collect calls will be accepted. Electronic quotations will be accepted. All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through www.sam.gov.