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COMBINED SYNOPSIS / SOLICITATION Title: Reference Clinical Lab Testing and Assay Services (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Su... COMBINED SYNOPSIS / SOLICITATION Title: Reference Clinical Lab Testing and Assay Services (i) 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; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95020Q00151 and the solicitation is issued as a request for quotation (RFQ). This acquisition is 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, and is expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-06, dated June 5, 2020. (iv) The associated NAICS code 621511 and the small business size standard $35M. This requirement is full and open with no set-aside restrictions. (v) The National Institute on Aging (NIA) Laboratory of Behavioral Neuroscience requires reference clinical laboratory testing and assay services for the Baltimore Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study. (vi) Description of Services: Background: The Intramural Research Program (IRP) of the National Institute on Aging (NIA) provides a stimulating setting for a comprehensive effort to understand aging through multidisciplinary investigator-initiated research. The Laboratory of Epidemiology and Population Sciences (LEPS), one of NIA IRP’s ten laboratories, plans, conducts, and directs epidemiology, demography, and biometry programs relevant to the mission of the NIA; collects and analyzes data regarding the distribution of the aged by such categories as sex, race, socioeconomic, and demographic characteristics and serves as a focal point for these data; and plans, initiates, coordinates, and analyzes national and international epidemiologic longitudinal studies and studies of special populations. Within LEPS, the Health Disparities Research Section (HDRS) conducts interdisciplinary clinical and basic science research focused on examining the underlying cause of the disproportionate incidence, morbidity and mortality of age-related disease among minority and low socioeconomic status (SES) Americans. The approach provides a two-way bridge between basic science laboratory studies and clinical research that spans from the targeted epidemiologic population to the bench. Dissecting the interaction of race, socioeconomic status, culture, behavior, environmental exposure, biologic vulnerabilities, genetics, social environment, health care access, and quality of health care provides insight into how these interactions result in disproportionate rates of age-related disease and disability. The ultimate goal of this approach is to transform scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce incidence, morbidity, and mortality of age-associated diseases and health disparities. This is accomplished by the development and implementation of a clinical component (The Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study) and a basic science laboratory component that are interdependent and pursuing related hypotheses. HANDLS investigators conduct their research study on NIA’s mobile Medical Research Vehicles (MRVs) located throughout Baltimore City, MD. Participant samples and specimens are collected routinely during examinations performed daily. Additionally, and to avoid informative censoring (non-random missing data), NIA has also developed the HANDLS Home Visit Program (HHVP). This protocol is designed to allow participants who are home bound or disabled to continue to participate in the HANDLS study as scheduled. Providing an alternative to the examination visit on the MRVs allows NIA to continue to collect valuable data about the influences of race and socioeconomic status (SES) on the development of age-related health disparities and disability among socioeconomically diverse African Americans and whites in Baltimore. Purpose and Objectives: Reference Clinical lab testing and assay services are required for the participant visits at the MRVs as well as the HHVP. These assays are one basis for establishing participants’ health records. The data are used by investigators to assess change over time. These results are medico-legal documentation. They are retained in participants’ medical charts and participants are provided copies for their records and, if they choose, for their physicians’ records. The Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by the NIA HANDLS physicians. Services shall include the transportation of clinical laboratory specimens to the contractor’s laboratory(ies) (including providing the shipping/pickup containers), the performance of analytical testing as defined by the Contractor’s reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility. A list of required clinical and research tests is attached to this solicitation. See attachment titled “75N95020Q00151_List_Required_Tests” Project requirements: Please see attachment titled "75N95020Q00151_SOW" Deliverables and Reporting Requirements: Please see attachment titled "75N95020Q00151_SOW" Government Responsibilities: Please see attachment titled "75N95020Q00151_SOW" Technical Evaluation Criteria: Please see attachment titled "75N95020Q00151_TEC" Contract Type: The Government anticipates awarding one Firm-Fixed Price (FFP) contract as a result of this combined synopsis/solicitation. Anticipated period of performance: The period of performance for this contract will include a base period of one year (07/01/2020 – 06/30/2021) followed by three (3) consecutive 12 month option periods. Basis for Award: Responses will be evaluated on a comparative basis in accordance with FAR 13.106-2. Other important considerations: All data provided to the Contractor must be treated as confidential and not be disclosed to any third party. (vii) Place of Performance: Inspection and acceptance will be performed at: 251 Bayview Boulevard Baltimore, Maryland 21224 United States (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016) FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018) FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Oct 2018). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.217-8, Option to Extend Services (Nov 1999). FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text: FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Oct 2018) NIH Invoice and Payment Provisions (2/2014) (ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In addition to price, the following factors shall be used to evaluate quotes: Technical Approach, Qualified Personnel, and Equipment and Facilities. Please see attachment titled "75N95020Q00151_TEC" 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). 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. (x) The Offeror is to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer. (xi) The 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. There are no additional contract requirements or terms and conditions applicable to this acquisition. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price quotation must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate for each labor category, breakdown and rationale for other direct costs or materials, and the total amount. The price quotation should contain all information necessary to allow for a comprehensive evaluation of the prices including an accompanying narrative that fully describes all assumptions made by the contractor. The price quotation should contain sufficient information to determine the reasonableness of services proposed and to evaluate whether the proposed prices are consistent with the technical proposal. All evaluation factors other than price, when combined, are significantly more important than price. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.” All quotations must be received by 12:00 p.m. (noon) Eastern Daylight Time, Wednesday, July 8, 2020 and reference solicitation number 75N95020Q00151. Responses must be submitted electronically to Renee Dougherty, Contracting Officer, at renee.dougherty@nih.gov. Fax responses will not be accepted. (xv) The name and telephone number of the individual to contact for information regarding the solicitation: Renee Dougherty, Contracting Officer, 301-827-8453, renee.dougherty@nih.gov