Q301--Specialized Genetic Testing Services

estricted. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a small business size standard of $41.5 million. The FSC/PSC is Q301. The VA South Texas Healthcare System at the Audie L. Murphy Memorial Veterans' Hospital, Pathology & Laboratory Medicine Service, 7400 Merton Minter Blvd., San Antonio TX 78229 is requesting brand name or equal Specialized Genetic Laboratory Testing and studies that produce evidence to reduce variants of unknown significance (VUS). All interested vendors shall provide quotations for the following: Line Items 0001, 1001, 2001, 3001, 4001 CancerNext Testing to include genes APC, ATM, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDKN2A, CHEK2, EPCAM, FH, FLCN, GREM1, HOXB13, MBD4, MET, MLH1, MSH2, MSH3, MSH6, MUTYH, NF1, NTHL1, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, RPS20, SMAD4, STK11, TP53, TSC1, TSC2, VHL and Line Item 0002, 2001, 2002, 2003, 2004 ColoNext Plus RNA Insight to include genes APC, AXIN2, BMPR1A, CDH1, EPCAM, GREM1, MBD4, MLH1, MSH2, MSH3, MSH6, MUTYH, NTHL1, PMS2, POLD1, POLE, PTEN, RPS20, SMAD4, STK11, TP53, RNA Insight: AIP, ALK, APC, ATM, ATRIP, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDC73, CDH1, DK4, DKN1B, CDKN2A, CEBPA, CFTR, CHEK2, CPA1, CTNNA1, CTRC, DX4, DICER1, EGFR, EGLN1, EPCAM, ETV6, FH, FLCN, GATA2, GREM1, HOXB13, KIF1B, KIT, LZTR1, MAX, MBD4, MEN1, MET, MITF, MLH1, MLH3, MSH2, MSH3, MSH6, MUTYH, NF1, NF2, NTHL1, PALB2, PALLD, PDGFRA, PHOX2B, PMS2, POLD1, POLE, POT1, PRKAR1A, PRSS1, PTCH1, PTEN, RAD51B, RAD51C, RAD51D, RB1, RET, RNF43, RPS20, RUNX1, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, SMARCA4, MARCB1, MARCE1, SPINK1, STK11, UFU, TERT, TMEM127, TP53, TSC1, TSC2, VHL, WT1. The Contractor must provide complementary studies that produce evidence to reduce variants of unknown significance (VUS). The laboratory must be able to provide evidence of supporting variant classifications in the final results report sent to clinicians. The evidence summary must include any significant published literature references as well as internal laboratory data weighted towards the reported classification for full transparency. The Contractor must also perform specialized studies, such as targeted RNA analysis of splicing variants and Ribonucleic Acid (RNA) / Deoxyribonucleic Acid (DNA) tandem analysis, providing the necessary data points to better define whether a VUS is benign (normal variation) or pathogenic (disease-causing). Contractor shall provide the following tests in-house. Test must be brand name or equal to the test description described below. The Laboratory selected is required to be fully licensed, accredited and inspected by the Laboratory Accreditation of an accrediting agency to include College of American Pathologists (CAP) with deemed status from the Center for Medicare and Medicaid Services, Center for Disease Control and any other state regulatory agencies as mandated by Federal and State Statutes. The Laboratory is required to be certified by the Joint Commission, American Associates of Blood Banks (AABB) as applicable. The Clinical Laboratory shall meet all requirements set forth by the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA). In addition, contractors must meet all requirements outlined in VHA Directive 1106. These above-mentioned requirements must be met upon the date of Solicitation. The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/browse/index/far. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of RFO FAR 12. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. Options will be evaluated at time of award. The following are the decision factors: 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 will be used to evaluate offers; Technical Capability Past Performance Price Evaluation Approach. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. Failure to provide the information requested may result in being found non-responsive. The evaluation will consider the following: Technical Capability: Contractor shall clearly demonstrate the ability to meet all requirements in the Statement of Work. Offers will be rated as meets technical factors, exceeds technical factors, does not meet technical factors. Any offer that does not meet the technical factor will not be considered for award. Past Performance: Past performance will be evaluated for past performance using assessment reports in Contractor Performance Assessment Reporting System (CPARS). A review of assessment from the past five (5) years will be used. Vendors with no past performance history will be rated "Neutral" for past performance. Ratings for past performance will be categorized as either Less than Satisfactory, Satisfactory, or Better than Satisfactory. Price: In evaluating the offeror s proposed price for this procurement, the techniques and procedures described under RFO 12.204(a), Price reasonableness. Price will be evaluated for reasonableness, completeness, and fairness by comparing the proposed prices for each period with the prices posed by other offerors and by comparison with the Independent Government Cost Estimate (IGCE). Evaluation of Options. For purposes of award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause. The evaluation will, therefore, assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the affect the ranking of quotes based on price, unless, after reviewing the quotes, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8. The award will be made to the response most advantageous to the Government. Responses should contain your best terms and conditions. The following provisions are incorporated into 52.212-1 as an a