THIS IS A SOURCES SOUGHT NOTICE ONLY: This announcement seeks information from the industry, which will be used for preliminary planning purposes for procurement. No proposals are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS SYNOPSIS. THIS IS STRICTLY MARKET RESEARCH. Phlebotomy and Specimen Collection Services The purpose of this synopsis is to gain knowledge of interest, capabilities, and qualifications of various members of industry, who have the capability to provide Chemistry Drugs of Abuse Reagents. All interested firms must be registered in SAM (System for Award Management) to be eligible for the award of Government contracts. Interested parties responding to this Sources Sought request shall submit the following information at a minimum: (1) Company name and address point of contact with phone number and SAM UEI. (2) Documentation relating to performance capability, current point of contact, and phone number). (3) Socio-economic status to identify the business class as a large business, SDVOSB, VOSB, small business, Woman Owned, etc. (4) Place of manufacture (5) Any other pertinent company documentation prior to submission of offers to a solicitation. Any SD/VOSB firms responding to this Sources Sought Notice must also provide proof of registration in the SBA Vet Cert prior to submitting offers to a solicitation. This market research is for informational and planning purposes. This is not a solicitation and does not obligate the Government to issue a solicitation. Please be advised that the government will not pay any costs for responses and information submitted. All submissions are acceptable via Sarah.Ballentine@va.gov RESULTS INFORMATION: Respondents will not be notified of the results, and it is at the discretion of the Government to utilize results. Firms responding to this Sources Sought announcement, who fail to meet all requirements as stated above, and who fail to provide ALL the required information requested, will not be used to help the Government make the acquisition decision, which is the intent of this sources sought announcement. Performance Work Statement (PWS) Phlebotomy and Specimen Collection Services General: Services are required to perform off-site phlebotomy and specimen collection services for the Department of Veterans Affairs Medical Center (VAMC), Middletown Community Based Outpatient Clinic (hereinafter referred to as CBOC). The services will be provided in a state-of-the-art civilian medical facility and be within 5 miles of the CBOC. Past practice has shown patient compliance is low if specimen collection is > 5 mi from CBOC. The standard of services shall be at a level of quality; meeting or exceeding those outlined in the licensing and accreditation section of this PWS. Contactor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA). Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to perform Specimen Collection Services as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract. Objectives: Phlebotomy Services (off-site) Specimen Collection Services (off-site) Scope: The contractor shall provide phlebotomy and specimen collection services. Contractor shall provide specimen collection services to include materials, supplies, equipment and qualified supervision. All specimen collection services shall be performed at the Contractor s facility. Period of Performance: The period of performance shall be for five years. 10/01/2025 09/30/2030 Locations: The following VA Medical Centers plan on utilizing these services: VA Providence, RI, 830 Chalkstone Ave, Providence, RI 02908 Middletown CBOC, One Corporate Place (West Main Road at Northgate Road), Middletown, RI 02842 General Information - Contracting Laboratory: The Contractor will provide phlebotomy services as well as collection of urine specimens as needed to patients presenting with clinician orders from the VAMC. Phlebotomists and staff collecting specimens must have current Phlebotomy certification. The Contractor will process specimens to the extent needed to preserve specimen integrity (i.e. centrifugation, pour off, temperature-controlled storage, protection from light, etc). The Contractor will fax a daily record of blood and urine specimens being shipped to the VAMC for tracking purposes. Fax number provided upon award. The Contractor will accept and package for pick up by current Government contract courier all routine specimens collected in addition to any PAP, Occult Blood or other specimen collected on site or delivered by Middletown CBOC, for transport to the Providence VAMC. Packaging of specimens will be according to the protocols established between the VAMC and contractor. The Contractor will keep a log of patients served and forward a copy of this log to the Providence VAMC Laboratory Manager monthly for billing reconciliation. The Contractor Shall certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA). The contractor shall provide telephone number(s) and contact person(s) to be used by the VA Medical Center to inquire about specimen problems or issues, at all times. Contractor agrees to maintain the minimum acceptable service and reporting systems. Immediate (within 24 hours) notification must be given to VAMC upon adverse action by a regulatory agency. Contractor shall assign a specific local account representative. The Contractor s location and physical space shall be safe for Veterans. There shall be sufficient interior wait space to allow for required physical distancing, sufficient parking, handicap access, and ease of entry/exit to and from the physical location. Contractor Responsibilities: The Contractor must have an established specimen collection center or laboratory within 5 miles of the Middleton CBOC. The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract. The Contractor will provide phlebotomy and blood collection services between the hours 6:30am and 10:00am Monday-Friday. The Contractor must accept walk-ins and VA patients are not required to schedule appointments. The Contract will have specimens processed and packaged for transport by 10:30am Monday- Friday. Licensing and accreditation Contracting Laboratory and any Sub-Contractors: Shall have and maintain as current all licenses, permits, accreditation certificates required by Federal law and State law in the state of Rhode Island. Must comply with the regulatory requirements of the Centers for Medicare and Medicaid Services. Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. Federal Holidays: (The contractor does not have to perform on these holidays) New Year s Day Labor Day Martin Luther King Jr. s Birthday Columbus Day President s Day Veteran s Day Memorial Day Thanksgiving Day Independence Day Christmas Day Juneteenth Hours of Operation: The contractor is responsible for conducting business at minimum, between the hours of 6:30am 11:00am EST/EDT, Monday thru Friday, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract. Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contracting laboratory. Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend a post award conference convened by the contracting activity. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government. Contracting Officer Representative (COR): The COR will be identified by separate letter upon contract award. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. Key Personnel: The follow personnel are considered key personnel by the government: Wendy Strollo, Program Director, Network Consolidated Laboratory Jacqueline LaCroix, Quality Manager/Health System Specialist, Network Consolidated Laboratory Holly Charpentier, Program Support Clinical Laboratory Scientist, Network Consolidated Laboratory Jacqueline Hite, Program Support Clinical Laboratory Scientist, Network Consolidated Laboratory Jean McElreavy, Program Assistant, Network Consolidated Laboratory Gina Hawthorne, Lab Manager, VA Providence Jonathan Farias, Supervisor, VA Providence The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 7:30a.m. to 4:30p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons. Identification of Contractor Employees: All contract personnel attending meetings and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. VAAR (VA Acquisition Regulation) clause: All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted. RECORDS MANAGEMENT OBLIGATIONS A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. B. Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record: includes VHA records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their VHA contract. may include deliverables and documentation associated with deliverables. C. Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. ** VHA training for contractors is available in Talent Management System (TMS): Records Management for Records Officers and Liaisons, Item #3873736 D. Flow down of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor. The A&A requirements do not apply and a Security Accreditation Package is not required.