Spectra Optia Apheresis System and Disposables

Spectra Optia Apheresis System and Disposables Notice of Intent to Sole Source HHS-NIH-NIDA-SSSA-NOI-17-449 INTRODUCTION THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Terumo BCT, Inc. for a Spectra Optia Apheresis System and Disposables This is a combined synopsis/solicitation for commercial items 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 to the sole source contractor; a proposal is being requested and a written solicitation will not be issued. REGULATORY & STATUTORY AUTHORITY This acquisition is conducted as non-competitive for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, as well as the statutory authority of FAR Subpart 13.106-1(b) Soliciting from a Single Source. The acquisition is not expected to exceed the simplified acquisition threshold. Pursuant to FAR Subpart 13.501 (a) (1) (iii) the justification (excluding brand name) will be made available within 14 days after contract award or in the case of unusual and compelling urgency within 30 days after contract award. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95 dated January 19, 2017. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The associated NAICS code for this requirement is 811310 with size standard of $7.5 Million. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The non-competitive determination is based upon the market research conducted as prescribed in FAR Part 10--Market Research, which indicates that only Spectra Optia Apheresis Systems and associated disposables kits are acceptable to ensure continuity of science. These systems and kits have been used for an ongoing longitudinal research protocol for several years and the same exact equipment must continue to be used to ensure standardization of research data. The Spectra Optia Apheresis Systems and associated disposables kits are proprietary to their original equipment manufacturer, TerumoBCT. This company does not sell its equipment through any third party and no other vendor is authorized to provide the proprietary equipment. Therefore, only TerumoBCT can meet the needs of this requirement. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice if it is believed that the requirement may be met competitively. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. DESCRIPTION OF REQUIREMENT Background The National Institute on Aging (NIA) Intramural Research Program (IRP) Clinical Research Core (CRC) works to elucidate normative values and separate normal aging findings from disease states in aging in an effort to prolong disease-free states with age. The CRC serves as an infrastructure to facilitate the creation and development of therapeutic targets for the treatment of age-related disease across the NIA IRP. The CRC performs research in various protocol studies that have direct clinical applications to human aging and disease states. This equipment requirement is specifically related to NIH Institutional Review Board-approved protocol Cytapheresis of Volunteer Donors (03-AG-N316/),ClinicalTrials.gov Identifier NCT00104325, a study designed to provide white blood cells obtained by cytapheresis to NIA researchers for other in-vitro research studies. To ensure continuity of science and conformance with the IRB-approved protocol, equipment used in relation to this protocol must be the specific brand name only items detailed in this purchase description. Purpose and Objectives The purpose of this acquisition is to procure two (2) Spectra Optia Apheresis Systems and thirteen (13) IDL disposables kits for the National Institute on Aging (NIA) Clinical Research Core. Project Description The Government requires the following equipment: 1. Two (2) Spectra Optia Apheresis Systems (Terumo BCT Product No. 61000) 2. Two (2) Spectra Optia User Manual Kits (Terumo BCT Product No. 705244001) 3. One (1) Three-Day Operator Training for the Equipment (Terumo BCT Product No. 339000007) 4. Thirteen (13) Spectra Optia IDL Disposables Kits (6 disposables per kit) (Terumo BCT Product No. 10310) Delivery Requirements Delivery is required within two (2) months following contractor receipt of award. Equipment shall be delivered to the NIH/NIA Baltimore Campus, 3001 S. Hanover St., 5th floor, Baltimore, MD 21225 Contract Type A firm fixed price purchase order is anticipated. RESPONSE INSTRUCTIONS Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. Offerors must provide both 1) a technical response and 2) a separate price quotation. The price quote shall include: unit price, list price, product or catalog number(s); period of performance confirmation; product description; and any other information or factors that may be considered in the award decision. PLEASE ENSURE THAT ALL EVALUATION CRITERIA ARE SPECIFICALLY ADDRESSED IN ANY RESPONSE(S) SUBMITTED. EVALUATION CRITERIA FAR clause 52.212-2, Evaluation - Commercial Items (October 2014) applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below. Factor 1: Technical Approach The contractor shall detail in its technical proposal how it shall meet each of the project requirements. This shall include equipment and goods specifications as well as any warranty information. Technical approach shall be evaluated for conformance to requirements. Factor 2: Past Performance The Contractor shall provide a list of two (2) contracts or purchase orders completed during the past five (5) years, similar in size and scope to the requirements outlined in this Statement of Work. Experience must be specific to provision of microscope support services and shall include the following information for each contract or purchase order listed: a. Name of Contracting Organization b. Total Contract Value c. Description of Requirement d. Contract Period of Performance Past Performance shall be evaluated for relevance to the current requirement. EVALUATION METHOD Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale: Excellent The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. This clearly achievable approach includes several advantageous characteristics of substance, and very few disadvantages, which can be expected to result in outstanding performance. The risk of unsuccessful performance is very low as the proposal provides solutions which are unquestionably feasible and practical. These solutions are further considered very low risk in that they are exceptionally clear and precise, fully supported, and demonstrate a clear understanding of the requirements. Risk Level: Very Low Good The proposal demonstrates a sound approach which is expected to meet all requirements and objectives. This sound approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements. Risk Level: Low Acceptable The proposal demonstrates an approach which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements. Risk Level: Neutral Marginal The proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages. Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements. Risk Level: High Unacceptable The proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages. Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision. Risk Level: Very High APPLICABLE TERMS AND CONDITIONS INCORPORATED BY REFERENCE The FAR clauses and provisions below shall apply to this solicitation. 1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (October 2017), applies to this acquisition. 3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (January 2017), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4. FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (January 2017) is applicable to this acquisition. 5. FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (January 2017) apply to this acquisition. The following clauses shall be checked/included in this clause: 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note). 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). 52.222-26, Equal Opportunity (Sept 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) 52.222-50, Combating Trafficking in Persons (Mar 2015) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) 6. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. CLOSING STATEMENT All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by the closing date of this announcement must reference solicitation number HHS-NIH-NIDA-SSSA-NOI-17-449. Responses shall be submitted electronically to Lauren.Phelps@nih.gov. Fax responses will not be accepted. For information regarding this solicitation, contact Lauren Phelps by email at lauren.phelps@nih.gov or by phone at (301) 480-2453.