Newborn Screening Program Instrumentation and Reagents

The Colorado Department of Public Health and Environment (CDPHE) is soliciting qualified vendors to provide instrumentation, reagents, maintenance services, and analytical methods for the Newborn Screening Program serving Colorado and Wyoming residents through RFP 2026000143. This procurement encompasses eight distinct workflows covering cystic fibrosis screening, endocrine disorders (T4 and 17OHP initial screening plus TSH second-tier testing), galactosemia, genetic metabolic disorders and X-linked adrenoleukodystrophy, hemoglobinopathies, and lysosomal storage disorders, with combined annual testing volumes of approximately 245,000 samples operating six days per week. Vendors may propose pricing through direct equipment sales with service contracts or alternative reagent-rental arrangements where the State pays a fixed price per unit of reagents and supplies. Deliverables include a minimum of two instruments for backup capability, fifteen software licenses, a gateway computer for network communication, installation services, on-site preventive maintenance scheduled at least twice annually, technical support Monday through Friday from 8:00 AM to 5:00 PM EST, training documentation, and comprehensive reporting including installation quality reports, preventive maintenance logs, and monthly service logs. All proposed testing methods must demonstrate FDA clearance or pending FDA clearance and comply with CLIA quality assurance and quality control requirements, with instruments capable of processing up to 500 samples within a 24-hour period. The written inquiry deadline is February 19, 2026 at 2:00 PM MDT, proposals are due March 12, 2026 at 2:00 PM MDT, evaluation is estimated for the week of March 16, 2026, and the anticipated purchase order effective date is May 1, 2026. The initial contract term extends from May 1, 2026 through April 30, 2027, with the State retaining sole discretion to renew for up to nine additional one-year periods not exceeding ten years total. Instruments must be delivered prior to October 31, 2026, and all costs must include actual figures for shipping and delivery.

Resident bidder preferences and Service Disabled Veteran Owned Small Business (SDVOSB) preferences of up to 5% on bid price are available to eligible vendors, though no specific incumbent vendors or current contractors are identified in the solicitation documentation. The State intends to finalize contracts and potentially purchase instruments prior to the end of Colorado's fiscal year, with funding sourced entirely from state funds in the Colorado Newborn Screening Cash Fund, though federal grants may potentially support future service expansion. The estimated total budget for the initial five-year contract period is $15,500,000, with the first-year budget of $2,900,000 for instrumentation and reagents (July 1, 2026 through June 30, 2027), followed by annual budgets of approximately $2,853,000 for reagents and $236,000 for maintenance, with projected 3% annual increases thereafter. The CDPHE's Laboratory Information Management System (LIMS) is capable of generating worklists and receiving results in industry-standard open formats and can be integrated with vendor instruments, requiring vendors to demonstrate compatibility with existing infrastructure. Vendors must maintain comprehensive insurance coverage including workers' compensation, commercial general liability with minimum limits of $1,000,000 per occurrence, and automobile liability insurance of $1,000,000 combined single limit, with the State named as additional insured on all policies. The State reserves the right to award to a single offeror or multiple offerors and to reject any or all proposals based on evaluation criteria that may include oral presentations or facility inspections at the vendor's expense.