Reference Clinical laboratory testing and assay services for the (HANDLS) study.

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The National Institute on Aging is conducting market research to determine the existence of interested sources capable of providing Reference Clinical laboratory services for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study. This notice is being issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred

by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond. Background: The National Institute on Aging (NIA) leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. 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, in this regard. The National Institute on Aging is conducting market research to determine the existence of interested sources capable of providing Reference Clinical laboratory services for the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study. Purpose and Objectives: The contractor shall perform 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. Project requirements: Testing types: see attached Lab Panel (attachment1) Specimen Pick-up: Weekdays: daily Monday-Friday of each week, except for holidays. Weekend days to include up to 2 per month and could occur on Saturday and/or Sunday. Pick-up time: between 1:00p-1:30pm. Deliver to contractor’s laboratory within 5 hours for processing. Turnaround Time (TAT): Laboratory shall deliver or transmit results of a routine nature (general routine chemistries) to NIA within 24 hours from the time the specimen is received by the Laboratory’s testing facility. The Laboratory shall transmit or deliver results of tests performed on specimens of a special nature (special chemistries, tissues, etc.) to NIA within the times set forth in Laboratory’s then current turn-around-time schedule. Specimen Collection and Handling Requirements: Laboratory shall provide instructions for specimen collection, and handling and requirements that adhere to best practices and includes volume and storage temperature. Sample Preparation/Transport: The packaging and transportation procedures must ensure the integrity of the specimen throughout the shipment process. A specimen collection and packaging guide shall be in place. Supplies: Laboratory will provide, as part of its charges for the services, such items, devices or supplies that are used solely to collect, preserve, package, transport, process, or store specimens to be submitted to Laboratory for testing including, but not limited to: Forms, Specimen containers, Special media or culture tubes for samples, Specimen preservatives, Dry ice, Shipping and packaging containers, Specimen carriers, Labels and label printers as required by transportation guidelines, Centrifuge(s), etc. Tracking of specimen: Tracking must be maintained from the initial pickup/shipping of the specimens from the ordering activity throughout the testing process at the contractor’s laboratory. Consultation: Contractor’s laboratory staff (technical directors, pathologists, etc.) shall be available in person or by telephone during normal Laboratory working hours to discuss laboratory procedures and to provide the status of test results. Testing: Required test panel attached. All clinical reference laboratory testing shall be executed in accordance with standard industry practices. All test methods shall be FDA approved. Test Reporting: Participant formatted reports on website. The contractor shall provide access to a secure electronic health record website that provides formatted copies of laboratory reports including, but not limited to, test names, results, units, alert values, and reference ranges. Reports shall be available within 24 hours of specimen receipt. Electronic results downloaded via HL7 protocol. The contractor shall provide an information system for downloading participant assay consistent with the Health Level Seven standard protocol for the transfer of clinical and administrative health data. The contractor shall provide access to their HL7 server and shall provide any necessary client software required for NIA to download and store these assay results in their database. The contractor shall provide all required hardware and software (including installation) and related consumable supplies to support the transmission of electronic data for each ordering activity. Any necessary “additional required connections” shall be the responsibility of the contractor. Procedure Guidance: The contractor shall make available either through its electronic catalog or upon request the following information: Specimen collection and handling requirements Test reference intervals adjusted for ages, sex, or race, when required. Test specific sensitivity, specificity, and interferences, when required. Result code (electronic transmissions only) Test critical values if any. Location of test performance by test name (i.e. name of primary laboratory, name of separate branch division of primary lab, name and address of secondary/subcontracted laboratory must be cited) Other important considerations: Documentation: The contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and accuracy of all prepared and transcribed reports. The Contractor shall have a system in place to identify the personnel performing the test analysis. Utilization Reports: The contractor, upon request, shall provide to each ordering activity at a minimum, the utilization reports customarily provided to commercial customers. The report shall at minimum identify the test code, test name, YTD volumes, unit cost, YTD expenditures, and turnaround times. Contract Quality Assurance/ Quality Control: The contractor facilities, test methodologies (defined as the principle of the method), validation studies, and quality control information may be examined by representatives of the Government at any time during the life of the contract. The contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required. HIPAA Compliance: Contractor must acknowledge it is a “covered entity” under the Health and Portability and Accountability Act of 1996 (HIPAA) and agree to comply with the requirements thereof, as well as all other applicable laws and regulations pertaining to patient privacy. See 45 CFR 160.103 for definition of “covered entity”. CLIA Compliance: The contractor must be licensed to perform laboratory testing under the Clinical Improvement Amendments (CLIA) of 1988 and perform testing in accordance with the CLIA regulations. Licensing and Accreditation: The contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency with deemed status from the Centers for Medicare and Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, mandated by federal and state statues. The Contractor must maintain valid certifications throughout the performance period of this contract. Liability Insurance: Contractor must provide evidence of current liability insurance. Anticipated period of performance:The period of performance will be 07/24/2024 - 07/23/2025 for the base year, plus the option to exercise four (4) optional years is being sought. Place of Performance:The principal place of performance is the contractor’s work site. Travel expenses related to the sample collection sites shall not be reimbursed. Sample collection sites are: 1) NIA’s mobile Medical Research Vehicles (MRVs) located throughout Baltimore City, MD and, 2) National Institute on Aging, NIA Clinical Core Laboratory & Biorepository 3001 S. Hanover Street, Baltimore, Maryland 21225. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement/information sought paragraphs stated herein. A cover page and an executive summary may be included but are not required. The response is limited to a ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Iris Merscher, contract specialist, at e-mail address iris.merscher@nih.gov. The response must be received on or before March 28, 2024, 5:00 pm, Eastern Daylight Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).