Q301--Tissue Typing and Immunogenetics Lab Services

The Department of Veterans Affairs has awarded a sole-source contract to The Rogosin Institute Inc. for comprehensive tissue typing and immunogenetics laboratory services supporting renal and solid organ transplantation at the James J. Peters VA Medical Center in the Bronx, New York. The contract, valued at $390,610, has a base period of one year with four one-year option periods, extending potential performance up to five years. Services must be available 24 hours a day, seven days a week, 365 days a year, including all federal holidays, with rapid turnaround times required: verbal results for HLA typing, antibody screening, and crossmatching must be delivered within four hours, and virtual crossmatches within two hours. The contractor is responsible for all laboratory operations, including specimen receipt, testing, reporting, and storage, with zero tolerance for specimen misidentification and an accuracy requirement of 99.9% for HLA typing. All testing must comply with ASHI accreditation and CLIA certification standards, and the contractor must participate in External Proficiency Testing programs. The facility must be operated from The Rogosin Institute’s laboratory in Manhattan, while oversight and acceptance occur through the VA’s Contracting Office in Albany, NY. The contractor is required to maintain full compliance with HIPAA regulations, including encryption of electronic protected health information and role-based access controls, and must ensure all personnel are qualified per ASHI and ABHI standards, including a diplomate-led laboratory directorship. A comprehensive contingency plan must be in place to ensure uninterrupted service during emergencies, identifying alternative vendors and logistics for sample transfer. The VA does not furnish any equipment or resources; the contractor must supply all personnel, materials, facilities, and infrastructure. The contract prioritizes veteran patients above all others, even during peak demand, and requires adherence to Organ Procurement and Transplantation Network regulations. The award followed a determination of unique capability under FAR 6.302-1, as no other entity possesses the specialized expertise, technology, and accreditation required to meet the strict performance standards. All submissions were required electronically, and the contractor must submit regular quality control data, proficiency results, and laboratory reports with interpretive clinical guidance for each test.