6630--V16 Lab Chemistry and Immunochemistry CPRR BPA (VA-25-00010416)

Network Contracting Office (NCO) 16 will be issuing a Request for Quotation (RFQ) for the South Central VA Health Care Network (SCVAHCN) VISN 16 in the coming months to award a Cost per Patient Reportable Result (CPRR) Blanket Purchase Agreement (BPA) for VISN wide standardized automated Chemistry and Immunochemistry instrumentation and testing to a Federal Supply Schedule FSC Group 66 III schedule holder manufacturing instrumentation and reagents and performing service and repair under SIN 605-1a. The BPA will include use of instrumentation, reagents, calibrators, controls, consumables, parts, contractor performed operator training, contractor performed preventative maintenance, repair, and remote troubleshooting and connectivity through Data Innovations middleware to the VA VistA Lab Information System (LIS).

The fully automated instrumentation shall have random access testing capabilities and be able to simultaneously perform the complete profile (full test menu) meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

Testing Instrumentation and reagents shall be FDA approved and validated for use.

Contractor has proprietary reagents for proposed instrumentation, use of third party reagents (user-defined applications) should be kept to a minimum.

Reagents shall be liquid ready to use or require minimal to no operator preparation prior to use.

New equipment is required for each of the clinical laboratories located at the VISN facilities listed in the VISN 16 Site Visit Workbook. Includes 8 medical center and 20 outpatient clinic laboratories.

Instrumentation shall have a current VA Enterprise Risk Assessment (ERA).

Same manufacturer, methodology and reagent system for testing instrumentation across VISN 16 laboratories (for like tests).

Immunochemistry (IC) test menu/reagent capacity shall be sufficient to support testing for the full laboratory test menu on a single instrument. Additionally, each IC instrument shall have excess reagent position capacity.

A UPS with surge suppressor/line conditioner shall be provided for each instrument/piece of equipment.

All-inclusive CPRR pricing.

Pre and Post analytical automation requirements for medical center laboratories and the Joint Ambulatory Care Center in Pensacola.

Automation line requirements include but are not limited to centrifuges, decappers, recappers, aliquotors, refrigerated storage as well as instrument and specimen management systems.

Data management systems to enhance workflow and operations for all instrumentation.

For instrumentation that requires a continuous feed of water, water systems capable of generating the required quality, pressure and volume of water to meet manufacturer s specifications and sustain instrument operations to support maximum throughput are required to be provided by the Contractor for each instrument.

For laboratories requiring more than one water system, the configuration should be established to support instrument operations through the use of a large temporary water storage tank or similar application should one water system be non-operational.

Water system configuration shall also support bypassing the temporary water storage tank as necessary.

Basic operator training on testing instrumentation for all operators.

Key operator training (off-site) for 2 operators the base year and one operator each subsequent year. Training requirements are per instrument.

Telephone assistance center/hotline- available by telephone 24 hours per day, 7 days per week with immediate response or a call back time of 30 minutes.

Equipment repair shall be provided 24 hours per day, 7 days per week for medical center labs and 5 days per week business hours for outpatient clinic labs.

A VA approved MOU/ISA is required to provide and support remote troubleshooting for all laboratories.

The above is not an all-inclusive list of requirements. The minimum technical requirements and technical evaluation factors will be included in the solicitation when posted. All instrumentation must be FDA approved, in current production at the time of quotation submission, discontinued models and refurbished instrumentation shall not be presented. Operating system software shall be currently sold and supported by its manufacturer. Instrumentation, systems and/or devices with operating systems such as Windows XP, Windows, 6 CE Embedded, etc. shall not be proposed.

This is a Pre-solicitation notice only and is NOT the actual RFQ. The RFQ will be posted to GSA e-Buy at a later date.

The purpose of this notice is to provide FSS FSC Group 66 III contractors minimally meeting the above requirements the opportunity to conduct site visits with participating laboratories to assess the requirements for each site and inform laboratories of their instrumentation available to potentially meet those requirements.  The VISN 16 Site Visit Workbook contains 3 tabs. The first tab lists the address, phone number, name of the Lab Manager and/or points of contact for the VISN 16 laboratories to assist Contractors in scheduling site visits. The second tab contains existing instrumentation and new instrumentation requirements for each lab. The third tab provides the annual estimated testing volumes for each laboratory and their respective test menu. Note: VISN 16 Site Visit Workbook contact information, equipment requirements and test menus are subject to change prior to the posting of the competitive solicitation/RFQ.

Site visits are authorized from the date of this posting until 02/28/2025.

Vendor site visits shall be in person and include the appropriate stakeholders for each laboratory. The visit shall be scheduled in advance at a mutually agreed upon date and time, to ensure patient care is not compromised and presentations/discussions are well attended. This is an opportunity for each vendor to discuss equipment operation, technical capabilities, maintenance requirements (both operator and contractor performed), data management functionality and connectivity with each laboratory related to their specific requirements. Contractors shall also discuss site specifications including utilities, space requirements, and weight for each instrument model, automation line component, etc. Literature detailing site specifications shall also be provided in written or electronic format to each laboratory. The expectation is that all participating laboratories listed in Attachment A are visited. Due to the complexity of automation lines and space requirements more than one visit may be necessary for the medical center laboratories and the Joint Ambulatory Care Center in Pensacola. Visits and presentations for outpatient clinic labs should be accomplished in a single visit.

Please do not take in equipment or take VA staff to see equipment. A draft test menu and annual estimated volumes (this could change prior to the posting of the RFQ) for each lab has been provided. Using that information you should present how your instruments would manage that workload. CAD drawings will not be provided for the site visit, however, photos for laboratories requiring automation lines will be provided upon request. Additionally, any request for the use of digital measurement software and/or platforms shall be submitted to Diyonne Williams, Contracting Officer, at Diyonne.Williams@va.gov, for review well in advance of any scheduled site visit. Include 36C256-24-AP-5589 Chemistry Site Visit in the title of your email.