This is a FBO Special Notice of Intent to award a sole source. The Department of Veterans Affairs (VA) Network Contracting Office 2 (NCO 2), on behalf of the VA New York Harbor Healthcare System, New York, intends to award a sole source to College of American Pathologists (CAP) - 325 Waukegan Road Northfield, IL 60093 for Laboratory Accreditation Program. The period of performance will be effective October 1, 2020 through September 30, 2021 with four twelve months option years through September 30, 2025. The requirement is a non-personal service to provide accreditation of laboratory services. The Contractor shall be identified by Centers for Medicare and Medicaid Services (CMS) as a deemed accrediting agency under the Clinical Laboratories Improvement Amendment (CLIA) and identified by The Joint Commission (TJC) as having a comparative agreement pursuant to the Cooperative Accreditation Initiative. Veterans Health Administration (VHA) Laboratories have been accredited for over 40 years. The laboratory accreditation process is a complex system of related and dependent activities. The New York Harbor Healthcare System s laboratories are considered moderate and high complexity labs. It includes proficiency testing, on-site survey with pre and post inspection activity, and continuous monitoring. Inspection activity includes several phases of activity including pre-inspection, on-site inspection, post-inspection activities and lab enrichment activities related to inspection readiness and compliance education. Continuous monitoring may include activities such as off-cycle activity/self-inspection, proficiency testing ordering checks, inspection follow up, and educational activities. Accreditation is an accumulation of inspection service and continuous monitoring. Maintaining laboratory accreditation is directed by: VHA Handbook 1100.16 which establishes policy and responsibilities in obtaining and retaining hospital accreditation VHA Handbook 1106.01 which establishes policy and responsibilities for Pathology and Laboratory Medicine Service (P&LMS) The objective of this requirement is to supply on-site inspection services and continuous monitoring for accreditation for the New York Harbor Healthcare System. Inspection services are a requirement of maintaining laboratory accreditation under CLIA and TJC Hospital accreditation agreement. Accreditation aligns with one of P&LMS National Enforcement Office (NEO) strategies under quality improvement. Laboratory accreditation confers recognition that a laboratory meets certain standards of quality and safety, and confers compliance with healthcare quality standards of payors, both public (e.g., Medicare) and commercial. This requirement includes inspection services for the defined Food and Drug Administration (FDA) complexity levels (high and moderate), at New York Harbor Healthcare System s Manhattan and Brooklyn campuses, where patient testing is performed. Quality measures and specialties/subspecialties (in language/terms referenced on CMS, Clinical and Laboratory Standards Institute (CLSI)) that fall under this requirement may include but are not limited to: Specialties Chemistry, Diagnostic Immunology, Hematology, Microbiology, and Pathology Subspecialties - Bacteriology, Blood Gas, Body Fluid Analysis, Coagulation, Cytology, Endocrinology, Flow Cytometry, General Immunology, Gynecologic Cytopathology, Histopathology, Electron Microscopy, Immunohistochemistry, Intraoperative Consultation/MOHS, Molecular Biology, Molecular Microbiology, Molecular Pathology, Mycobacteriology, Mycology, Oral Pathology, Parasitology, Point of Care Testing, Point of Care Testing Provider Performed, Special Chemistry, Syphilis Serology, Surgical Pathology, Toxicology, and Urinalysis Quality Measure Inspection Areas -Safety, Specimen Collection, Laboratory Computer Services, Environment, Communications, Laboratory Director Responsibilities; Quality Improvement, Complaint Review, and Autopsy Pathology Blood bank/Transfusion service inspection is not a requirement of this contract, although the capacity to coordinate inspections and accreditation timeframes with the AABB is preferred. Must have a formal process to update and modernize accreditation material to maintain standards/checklists that correlate with good laboratory practices. This will be a firm-fixed price. The VA New York Harbor Healthcare System is located at 423 E. 23rd Street, New York, New York 10010. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES; however, any firm that believes it can meet the requirements may give written notification prior to the response due date and time. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to perform the requirements. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely with the discretion of the Government. If no responses are received, the Government will proceed with the award. Responses are due by August 11, 2020 by 10:00am EST. Responses shall be submitted via email to
[email protected] Subj: Accreditation. Telephone requests or inquiries will not be accepted.