Q301--Reference Laboratory for Professional Pathology Services

Veterans Health Affairs, Network Contracting Office 5, is issuing this Notice of Intent to Sole Source in order to identify any potential sources that have the resources and capabilities to provide consultation services and laboratory testing on organ transplant patients. The government is contemplating a One (1) year, Firm Fixed Price contract to satisfy this requirement and meet the needs of Washington DC VA Medical Center, 50 Irving Street, NW, Washington DC 20422. INTERESTED & CAPABLE RESPONSES NCO 5 is seeking responses from businesses that are interested in this procurement and consider themselves to have the resources, rights, and capabilities necessary to provide these services. Please respond with your: Business name Business type Socio-economic status (e.g., Veteran-Owned, Woman-Owned, Disadvantaged Small Business, 8(a), etc.) Person of contact (including telephone number & email address) GSA Contract number if applicable DUNS number and SAM UEI number Capability statement Authorization letter to perform consultation services and laboratory testing on organ transplant patients at Medstar Georgetown University Hospital at 3900 Reservoir Road NW, Washington, DC 20007. Responses must be submitted by 3:00 PM (EDT) Thursday, March 27, 2025. Responses to the information requested above may be submitted via email to contact@example.gov. No telephone calls will be accepted. DISCLAIMERS This Notice of Intent to Sole Source does not constitute a solicitation. All information received in response to this notice that is marked proprietary will be handled accordingly in accordance with (IAW) Federal Acquisition Regulation (FAR) 15.201(e). Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses incurred associated with responding to this RFI. This Special Notice of Intent to Sole Source is for planning purposes ONLY. The results of this notice will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., small business set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice. Reference Laboratory Testing & Consultation Services Statement of Work INTRODUCTION: The Department of Veterans Affairs Medical Center in Washington DC (VAMC DC), in partnership with Medstar Medical Group II LLC (MMG), MedStar Georgetown Medical Center, provides organ transplant services to veterans. Those services include kidney and liver transplant surgeries and MedStar Georgetown Medical Center laboratory services. MMG employs providers in the pathology department at MedStar Georgetown University Hospital. The Department of Pathology and Laboratory Medicine Service at the VAMC DC requires special consultation and laboratory testing on human organ transplant specimens and additional laboratory tests needed for transplant surgery. GENERAL: The contractor will serve as a reference laboratory for professional pathology services. The contractor shall provide laboratory consulting and reference testing for transplant patients in partnership with VA Medical Center Organ transplant services. The contractor will provide specialized reference laboratory testing to the Department of Veterans Affairs Medical Center in Washington DC (VAMC DC) Department of Pathology and Laboratory Services, 50 Irving St. NW Washington DC 20422. PERIOD OF PERFORMANCE: 05/10/2025 to 05/09/2026 PLACE OF PERFORMANCE: MedStar Georgetown University Hospital 3900 Reservoir Road NW Washington, DC 2007. PERFORMANCE REQUIREMENTS: The Contractor shall provide consultation services and laboratory testing on organ transplant patients. RESPONSIBILITIES Pathology Services Contractor will provide Pathology Services for VAMC, with such services to include renal consultations. VAMC agrees that all testing shall be requested by an individual authorized by applicable law to order clinical and anatomic pathology testing. Licensure Contractor will comply with the licensing and certification requirements under the Clinical Laboratory Improvement Amendments of 1988 ( CLIA ). Upon execution and upon additional request, Contractor will provide VAMC with CLIA licensure verification. Records & Lab Data Contractor will agree that clinical records of patients related to the ordering of pathology tests and/or the test reports shall be regarded as confidential, and shall comply with all applicable federal and stated laws and regulations governing the privacy and security of heath information, including without limitation HIPAA, and the regulations promulgated thereunder and shall remain in compliance with these laws and regulations as they may be amended from time to time, regarding the use and disposition of such data. Contractor will maintain records consistent with federal, state and local laws, rules and regulations, and organizational regulations and policies. INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 8852.273-75, Security Requirements for Unclassified Information Technology Resources. SECURITY/PRIVACY Ensure contractor understands and implements the IT security requirements for system interconnection documents required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk Management (IPRM) Portal and can be provided to the contractor. Ensure contractor understands their participation in IT security requirements for C&A of the VA system to which they connect. Enforce contractor performance (timely submission of deliverables, compliance with personnel screening requirements, and appropriate termination activity as appropriate). The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT s Enterprise Service Desk (ESD) by calling +1 (555) 000-0000 (TTY: 711). The ESD is OIT s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD. VA information will not be co-mingled with any other data on the contractor s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response. SPECIFICATIONS Laboratory Testing Requirements. The contractor must be able to perform all laboratory testing on Attachment A. There is urgency in getting the results from these specimens. The expectation is this work will be performed expeditiously Reporting Patient results will be signed out by MedStar Georgetown University Hospital pathologists (as needed) and reported through fax and email encrypted to VAMC. Patient Reports include the following information: Patient Name, Date of Birth and VAMC Case #. All preliminary results are to be reported to the submitting pathologist. A completed final report will be faxed to the attention of the submitting pathologist and faxed to +1 (555) 000-0000. Attachment A: Laboratory Test CPT Code Test Name 88313 Special Stains 88341 Additional IHC 88342 IHC 88360 Morphometric Analysis 88321 Consult 88323 Consult w/Slide Prep 88350 Immunofluorescence 88346 Immunofluorescence