Blood Donor Screening Tests approved by FDA for Blood Donations - US Naval Hospital Okinawa, Japan

NOTICE TO CONTRACTOR This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, in conjunction with FAR Part 13 Simplified Acquisition Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The solicitation number is HT941024Q2024. It is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-02 effective 1/22/2024 and Defense Federal Acquisition Regulation Supplement (DFARS) change 12/22/2023. The North American Industry Classification System (NAICS) Code for this acquisition is 325413. The size standard is 1,250 (# of employees). This is an unrestricted procurement, inviting full and open competition. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. This requirement is for . Defense Health Agency Contracting Activity (DHACA) Western Markets Contracting Division requests responses from qualified sources capable of providing the following: Enzyme ImmunoAssesys (EIA) testing of blood donor samples in accordance with the statement of work. Please review the statement of work. The vendor must test samples only using instrumentation and assays approved by the FDA for Blood Donations. The specific test methodologies, and approved manufacturers are listed in the link below, any other instrumentation or methodologies will not work and is a deviation from FDA guidelines. Vendors should submit their testing methodologies and manufacturer so we can ensure they are using the correct approved methods established by the FDA for our testing. The list of approved methods and manufacturers is listed below. https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays#Anti-T.%20pallidum%20Assays%20(detect%20antibodies%20to%20Treponema%20pallidum)and%20other%20serological%20tests%20for%20Syphilis The following is inserted as new paragraph (m) of the provision: (m) QUOTER INSTRUCTIONS The Government intends to award a firm-fixed-price (FFP) contract resulting from this RFQ to the responsible Quoter, whose quote conforms to the solicitation and is the most advantageous (best value) to the Government, price and other factors considered as defined in the EVALUATION FACTORS FOR AWARD section below. The Government will review the quotes received to determine if they are compliant with the RFQ requirements. A compliant quote is one that meets all of the terms, conditions, and specifications in the RFQ. The Quoter must provide all documents listed and comply with all RFQ instructions in order for their quote to be considered - compliant with this RFQ. Only compliant quotes will be evaluated for award. All questions regarding the RFQ, of a contractual or technical nature, must be submitted electronically by email to no later than :00 on , 22, . Questions submitted after the specified date and time may not receive a response. Questions, along with the Government's responses, will be posted as an attachment to the RFQ. Please be advised that the Government reserves the right to transmit those questions and answers of a common interest to all prospective Quoters. Quoters are instructed to electronically submit their complete quotation in one (1) single file, formatted in Portable Document Format (PDF) with a .pdf file extension as follows: - FACTOR 1: Technical Capability: The Quoter shall submit a capabilities statement, demonstrating the Quoter's technical capability (including OEM-certification or authorized reseller letter) to perform the required supplies in accordance with Table 1 of the Statement of Requirements. Offerors should provide approaches and address each Statement of Requirements paragraph in their capability statements. Capabilities statements shall be no more than 2 pages, in 12-point Times New Roman font, and with 1-inch margins. Spacing is at the discretion of the quoter. - FACTOR 2: Past Performance: The Quoter shall use Attachment 2 (Past Performance Questionnaire) to provide completed references for two (2) projects where you have provided RECENT and RELEVANT performance of the same or similar services required in this solicitation within the past three (3) years from the date of issuance of this RFQ. Past performance will be evaluated based on information from references provided and from authorized Government past performance systems and resources, including the Contractor Performance Assessment Rating System (CPARS). RECENT is defined as services performed within the past three (3) years from the date of issuance of this RFQ. RELEVANT is defined as services the same as or similar to the services specified in the Statement of Requirements. Past performance information not meeting the above criteria will not be used for evaluation. - FACTOR 3: Price: The Quoter shall use Attachment 3 (Quote Sheet) to submit a firm-fixed-price for all contract line-item numbers (CLINs) identified. Attachment 3 (Quote Sheet) shall be completed and signed, with acknowledgment of all amendments to the solicitation. No attempt to reformat or remove cells is authorized. Submission of pricing data shall be complete and accurate. Incomplete pricing may result in a Quoter's quotation being deemed ineligible for award. - Completed Provisions: Quoters shall be registered in the System for Award Management (SAM) with the appropriate NAICS code and completed representations and certifications and shall not have any active exclusions listed within SAM. Additionally, the Quoter shall include one (1) copy of the following FAR provision(s) located within this RFQ that shall be completed and included with the quote: 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment - FACTOR 4: Small Business Subcontracting Plan: Large Business Offerors shall submit a Small Business Subcontracting Plan in accordance with FAR 52.219-9 and DFARS 252.219-7003. When submitting proposals, offerors shall include a Small Business Subcontracting Plan (hereafter referred to as - subcontracting plan) for ensuring the maximum practicable participation of small business concerns in the performance of this contract as required by FAR 52.219-8, Utilization of Small Business Concerns and FAR 52.219-9, Small Business Subcontracting Plan (clauses are included by reference under FAR Clause 52.212.5). Submitted subcontracting plans shall include the content identified in FAR 52.219-9(d). Offerors who are small business concerns (based on the size standards for NAICS 811490, Other Personal and Household Goods Repair and Maintenance) are not required to submit Volume V, Small Business Subcontracting Plan in their proposal. (End of Addendum) LATE SUBMISSIONS MAY NOT BE CONSIDERED. It is a Quoter's responsibility, when transmitting its quote electronically, to ensure the quote's timely delivery by transmitting the quote sufficiently in advance of the time set for receipt of quotes to allow for timely receipt by the Government no later than the date and time stated in this RFQ. Quoters shall allow adequate time to upload files, which may be slower for non-DoD users, and to avoid other technical difficulties that may be encountered. A Quoter risks the late receipt and rejection of a quote where it delays transmitting its quote until the last few minutes before the time set for receipt of quotes. Quotes that are received after the date and time stated in this RFQ will not be considered except at the discretion of the Contracting Officer; the Contracting Officer reserves full discretion to accept any late quotes at any time prior to award if it serves the best interest of the Government. Quoters are responsible for submitting their quote in the format specified, consistent with requirements stated elsewhere in this RFQ. Quoters are asked to submit only the information required. Files that cannot be opened or are otherwise missing the required content are the responsibility of the Quoters. Submissions that do not adhere to format and content requirements may be considered non-compliant. The Government reserves the right to eliminate any such quotes from consideration for award. Quotations must be received no later than :00 on , 26, . (End of provision) 52.212-2 EVALUATION'COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) (a) The Government will award a contract resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (1) Technical Capability (2) Past Performance (3) Price (4) Small Business Subcontracting Plan Technical Capability will be rated on an Acceptable/Unacceptable basis, and Past Performance will be more important than price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Addendum to FAR 52.212-2, Evaluation'Commercial Products and Commercial Services The following is inserted as new paragraph (d) of the provision: (d) EVALUATION FACTORS FOR AWARD Contract award shall be made on a - Past Performance Price Tradeoff basis. This process allows for a tradeoff between past performance and price and allows the Government to accept other than the lowest priced quote or other than the highest rated quote to achieve a best-value contract award. This may result in an award to a higher-rated, higher-priced quote if the Government determines that the past performance of the higher-priced quote outweighs the price difference. The selection process is subjective by nature and professional judgment is implicit throughout the tradeoff process. The Quoter's technical capability will be evaluated to determine if it is acceptable or unacceptable in accordance with the evaluation criteria stated in this RFQ. Contractor must be an OEM-certified service provider or authorized reseller in order to be rated - Acceptable. If a Quoter's technical capability is determined to be unacceptable, the Quoter will no longer be considered for award. Award will be made to the Quoter providing a quote that is deemed most advantageous to the Government, whose technical capability has been determined to be - Acceptable and trading off past performance against price. Past performance is more important than price. The Government intends to award based on initial quotes. Notwithstanding this intent, the Contracting Officer reserves the right to conduct exchanges if it is within the best interest of the Government, a matter within their discretion. FACTOR 1: TECHNICAL CAPABILITY: The Government will use the following ratings/descriptions in Table 1 when evaluating technical capability: Table 1. Technical Capability Ratings Rating Description Acceptable Quote clearly demonstrates the Quoter's technical capability to perform the required services in accordance with the Statement of Requirements. Unacceptable Quote does not clearly demonstrate the Quoter's technical capability to perform the required services in accordance with the Statement of Requirements. FACTOR 2: PAST PERFORMANCE: The Government will evaluate past performance by reviewing the Quoter's submitted past performance information and information from other sources that may include, but are not limited to, Government personnel and information retrieved through CPARS. The past performance evaluation will result in an integrated assessment of the Quoter's probability of successfully performing the RFQ requirements. The past performance evaluation considers each Quoter's demonstrated recent and relevant record of performance in performing services the same as or similar to the services specified in the Statement of Requirements. The Government will consider the recency and relevance of the information, the source of the information, context of the data, and general trends in the Quoter's performance. The past performance confidence assessment rating is based on the Quoter's overall record of recency, relevancy, and quality of performance. These are combined to establish one performance confidence assessment rating for each Quoter. The Government will use the following relevancy definitions in Table 2 when determining relevant past performance: Table 2. Relevancy Relevancy Definition Relevant Past performance effort involved performance of services the same as or similar to the services specified in the Statement of Requirements. Not Relevant Past performance effort involved little or no performance of services the same as or similar to the services specified in the Statement of Requirements. The Government will use the following ratings/descriptions in Table 3 when evaluating past performance: Table 3. Performance Confidence Assessment Ratings Rating Description Substantial Confidence Based on the Quoter's recent/relevant performance record, the Government has a high expectation that the Quoter will successfully perform the required effort. Satisfactory Confidence Based on the Quoter's recent/relevant performance record, the Government has a reasonable expectation that the Quoter will successfully perform the required effort. Neutral Confidence No recent/relevant performance record is available or the Quoter's performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned. The Quoter may not be evaluated favorably or unfavorably on the factor of past performance. Limited Confidence Based on the Quoter's recent/relevant performance record, the Government has a low expectation that the Quoter will successfully perform the required effort. No Confidence Based on the Quoter's recent/relevant performance record, the Government has no expectation that the Quoter will be able to successfully perform the required effort. FACTOR 3: PRICE: The Government will evaluate the quoted price for price reasonableness. The following price analysis techniques may be used to ensure a fair and reasonable price: - Comparison of quoted prices received in response to the solicitation. - Comparison of quoted prices with the independent Government estimate. - Comparison of quoted prices with available historical information. The quoted price will be evaluated for the entire effort, inclusive of all options. Evaluation of options shall not obligate the Government to exercise the option(s). Price must be determined fair and reasonable in order to be eligible for award. A price is reasonable if, in its nature and amount, it does not exceed that which would be incurred by a prudent person in the conduct of competitive business. A price that is found to be unreasonably high may be indicative of an inherent lack of understanding of the solicitation requirements and may result in the overall quote not being considered for award. FACTOR 4: SMALL BUSINESS SUBCONTRACTING PLAN: Large Business Offerors will be evaluated to ensure that a Small Business Subcontracting Plan is included in accordance with FAR 52.219-9 and DFARS 252.219-7003. Proposal submittals that do not include a subcontracting plan (except as noted* below) will be evaluated as unacceptable. All unacceptable proposals may be deemed ineligible and eliminated from further evaluation. Submitted subcontracting plans shall include the content identified in FAR 52.219-9(d). Failure to submit a subcontracting plan that addresses all of the requirements in 52.219-9(d) may result in an offer being deemed non-responsive and unacceptable for award. The subcontracting plan goals identified in the offeror's subcontracting plan will not be a part of the evaluation to select an awardee. However, after selection is made, the Contracting Officer will negotiate with the apparent awardee to ensure that the subcontracting plan complies with 52.219-9 and that the plan's stated goals are acceptable to the Government. Pursuant to 52.219-9, failure to negotiate the subcontracting plan shall make the apparent awardee ineligible for contract award. *Note: Offerors who are small business concerns (based on the size standards for NAICS 811490, Other Personal and Household Goods Repair and Maintenance) are not required to submit a Small Business Subcontracting Plan.