Inactive

STATEMENT OF WORK Molecular Analyzer Rental/Lease VISN 19 SCOPE: Contractor shall provide clinical laboratory analyzer(s), reagents, consumables, software, software upgrades, comprehensive maintenance... STATEMENT OF WORK Molecular Analyzer Rental/Lease VISN 19 SCOPE: Contractor shall provide clinical laboratory analyzer(s), reagents, consumables, software, software upgrades, comprehensive maintenance, parts, ancillary equipment, and training via an Instrument Rental Agreement (IRA), Reagent Rental Agreement, CPT, or equivalent pricing structure for Molecular Diagnostic Testing for the following VA facilities at VISN 19 VA Medical Centers (VAMC) and VA Clinics (VAC): Cheyenne VA Medical Center: 2360 E. Pershing Blvd., Cheyenne, WY 82001 Northern Colorado VA Clinic: 4575 Byrd Drive Loveland CO 80538 Eastern Oklahoma VA Health Care System: 1011 Honor Heights Dr, Muskogee, OK 74401 Grand Junction VA Medical Center: 2121 North Avenue Grand Junction, CO 81501 Salt Lake City VA Health Care System: 500 Foothill Drive, Salt Lake City, UT 84148 Salt Lake City VA Clinics: Price VA Clinic, 189 South 600 West Suite B, Price, Utah 84501 Elko VA Clinic, 2719 Argent Ave Suite #9, Elko, Nevada 89801 Idaho Falls VA Clinic, 640 S. Woodruff Avenue, Idaho Falls, Idaho 83401 Roosevelt VA Clinic, 245 West 200 North, Roosevelt, Utah 84066 Cache Valley VA Clinic, 2380 North 400 East Suite G, North Logan, Utah 84341 Pricing should include price for instrument rental and a la carte pricing for reagents for said equipment. See chart in 3.6 for test list. DEFINITION: Instrument and reagent agreement: Invoicing is based on both a monthly flat rate, which includes equipment lease and comprehensive maintenance, and a la carte or as needed pricing for test kits. The fixed monthly charge for equipment rental and services shall include the following costs, unless otherwise agreed upon by both parties, for rental and existing instrumentation covering (a) equipment use, (b) software and software upgrades, (c) calibrators, controls and their inter-laboratory Quality Control (QC) comparison program, supplies, consumable/disposable items, parts, printers, Uninterrupted Power Supply (UPS), accessories and any other item required for the proper operation of Contractor s equipment and necessary for the generation of a test result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. It will also include the material to perform, as well as all other costs associated with, quality control, calibration, normal range, and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (d) All necessary maintenance to keep the equipment in good operating condition (This element includes preventive maintenance, emergency repairs, and all software upgrades, including Windows upgrades), (e) training for Government personnel, and (f) All packaging costs and shipping costs of supplies. Contractor shall provide delivery, installation and removal of equipment at no additional charge. The a la carte pricing for test kits shall be inclusive of all shipping charges. 3. GENERAL REQUIREMENTS: 3.1. Contractor shall provide new analyzers and equipment. Remanufactured or used models will not be accepted. 3.2. The analyzer shall streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround time, supporting improved patient outcomes, and improving the productivity of the using facility. 3.3. Contractor shall provide Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators, and all consumables necessary for analyzing/testing. 3.4. Additional tests/reagents/instrumentation may be added as new technology becomes available on the market. 3.5. Contractor shall provide comprehensive maintenance for Government-owned The Contractor analyzers listed in the Schedule. 3.6. Contractor shall be capable of providing the entire test library at a fixed price per kit, including, but not limited to: Kit Name: MRSA S. Aureus & MRSA Carbapenem-Resistant Genes Norovirus CDIFF COV2/FLU AB/RSV (FDA Cleared) Strep A TB/Rifampin Resistance Chlamydia/Neisseria Trichomonas Vaginal Infections (multiple) BCR-ABL (Chronic Myelogenous Leukemia (CML) Factor II & Factor V (thrombosis) 4. SYSTEM REQUIREMENTS: 4.1. Offered models of laboratory analyzers shall produce accurate and reproducible assays by established diagnostic methods. Models shall provide accurate test assay results for samples up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. 4.2. Contractor shall supply temperature and humidity requirements for the proper functioning of analyzers. 4.3. Analyzers shall conform to the VA facilities existing space. Equipment must be compatible to existing VA electricity, water, and power. 4.4. Equipment shall meet the volume requirements of each VA facility. 5. FACILITY SPECIFIC REQUIREMENTS 5.1. In addition to the general requirements, the Contractor shall provide, install, and validate Contractor-owned instruments with appropriate peripherals, validation material, quality control (QC), UPS, etc. Contractor shall also provide comprehensive maintenance for all equipment and installation necessary to meet the specialized configurations described for the participating medical facility. Contractor equipment and systems shall conform to the following parameters. Grand Junction 1 instrument capable of up to at least 16 samples at a time; countertop is acceptable Dimensions: 47 W x 30 D x 36 H Cheyenne WY 1 instrument capable of up to at least 16 samples at a time countertop is acceptable site 1 Dimensions: 48 L x 24 W x 19 H 2nd possible site: 24 W x 30 D x 25 H 3rd possible site: 32 W x 30 D x 32 H Northern Colorado 1 instrument capable of at least 8 samples at a time countertop is acceptable: Dimensions: 72 L x 36D Muskogee OK 1 instrument capable of up to at least 16 samples at a time countertop is acceptable Dimensions: 21 W x 13"D x 25 H Salt Lake City, Utah Main Hospital 5 Clinics: Price, Utah Elko, Nevada Idaho Falls, Idaho Roosevelt, Utah Cache (Logan, Utah) 1 instrument capable of up to at least 16 samples at a time countertop is acceptable (main hospital), in addition 5 instruments capable of running at least 2 samples at a time and must be counter top (clinics) Dimensions for Main Hospital: 84 W x 24 D x 26 H Dimensions for Clinics: 20 W x 24 D x 24 H 6. SOFTWARE AND INTERFACE: 6.1. Operational Features- Operating system software shall be currently sold and supported. Operating systems must conform to current VA security requirements and be upgraded to remain in compliance. The operating systems should be Windows 10 IoT ENT LTSC(Long-Term Servicing Channel) or above. Operating system must be able to receive current Windows security updates/patching. Software must be Technical Reference Model (TRM) approved for VA usage. 6.2. Ancillary support equipment and Interfacing - Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. carts for non-floor standing instrumentation, cabinetry to support/house the analyzer (if necessary), water systems (including polishers, filter, etc.), servers (if required) and universal interface equipment, etc. In addition, Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied. If a site already has a universal interface box, Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface instrument manager for the testing instrumentation quoted and one is needed to optimally interface the instrument, then Contractor is responsible for the acquisition of the universal interface manager, license(s) and everything else needed to connect with VA computerized hospital information system. If there are any software upgrades in the instrument, rental or existing, during its lifetime, Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. Commercial offerings - Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance. Computer disc containing contractor procedure manual in CLSI format or an on-line procedure manual in the instrument software. 6.3. Interface Requirements - Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system. Note: Laboratory Instrumentation uses network wiring to connect to the universal Interface (Data Innovations and RALS- for various clinics). The universal interface is on the medical VLAN (Virtual Local Area Network) and uses the network wiring to connect to the network. No patient data leaves the VA. 7. SUPPORT SYSTEMS (COMPREHENSIVE MAINTENANCE) 7.1. Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, and any incremental support equipment, e.g. water system, UPS, and UPS batteries, etc. 7.2. Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. Contractor shall provide the Government with a designated point of contact and telephone number and shall arrange to enable his maintenance representative to receive such notification. 7.3. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of 1 hour (60 minutes). 7.4. Equipment repair service shall be provided 24/7 for Medical Center-based laboratories and 5 days per week during core business hours for outpatient clinic laboratories. 7.5. The following facilities require business hours services (on-site Monday through Friday, except holidays; 8:00 am 5:00 pm, local time). Northern Colorado VA Clinic, Loveland, CO Price VA Clinic, Price, Utah Elko VA Clinic, Elko, Nevada Idaho Falls VA Clinic, Idaho Falls, Idaho Roosevelt VA Clinic, Roosevelt, Utah Cache Valley VA Clinic, North Logan, Utah 7.6. The following facilities require extended service hours (on-site 7 days per week, including Federal Holidays; at least 8:00 am 5:00 pm, local time). i. Cheyenne VA Medical Center, Cheyenne, WY ii. Salt Lake City VA Health Care System, Salt Lake City, UT iii. Grand Junction VA Medical Center, Grand Junction, CO iv. Eastern Oklahoma VA Medical Center, Muskogee, OK 7.7. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours for outpatient clinic labs. All such arrangements shall be coordinated between Contractor and VA laboratory personnel and shall be at no additional charge to the Government. 7.8. A service report shall be furnished to the Laboratory upon completion of each Preventive Maintenance (PM) and a malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: Date and time notified Date and time of arrival Serial number, type and model number of equipment. Time spent on repair Proof of calibration or calibration verification following repair or replacement of major components/systems to ensure compliance with current CAP accreditation requirements and CLSI guidelines. Description of malfunction and repair (if applicable) Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 7.9. Contractor shall leave a service call open pending verification that repairs have been completed by Contractor s maintenance personnel. 7.10. For each instrument provided Contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call. 7.11 . Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 7.12. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the Contracting Officer and designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance manufacturer s instruction, shall be solely that of Contractor. Each instrument provided by Contractor shall maintain an uptime of 95% in each month of the term of the contract. 8. TRAINING 8.1. Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services. 8.2. Provide initial in-depth training for two key operators at each VA site and for each individual instrument provided, all expenses paid. Provide annual training for one VA equipment operator, per each instrument, for each participating VISN 19 medical center at contractor s expense. 8.3. Thereafter, Contractor shall provide training for minimally one (1) operator per instrument per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the Government and Contractor. 8.4. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant at Contractor s expense. 8.5. Basic operator training for equipment shall be provided by Contractor on-site for all operators on all shifts, as applicable to each individual laboratory s testing schedule and hours of operation. 8.6. Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization, on site or at contractor s facility. 9. TRANSITION 9.1. Upon award of the requirement, the transition period to have all analyzers and peripherals installed and operational at the affected facility shall be 30 calendar days after award unless mutually agreed upon. During this same period all initial training of VA personnel in the operation and maintenance of said equipment shall also be complete. 9.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor's submitted transition plan shall not exceed 30 calendar days for installation and training of VA personnel, transition of all testing materials, reagents, and supplies, and performance of all correlations and validations unless mutually agreed upon. Failure of Contractor to conform to the transition period shall be considered as sufficient cause to terminate for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply. 9.3. No later than 90 calendar days after award, Contractor shall have completed full transition of all services under this agreement to include all correlation studies, validations, etc., and shall have full and sole responsibility for services under the awarded requirement unless mutually agreed upon. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe if the extension is through no fault of Contractor and is a result of delays due to the Government. 9.5. Site preparation specifications shall be furnished in writing by Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturers claimed specifications. The total equipment per specifications in each of the laboratories will not negatively impact the functionality and operations of the laboratory or pose a safety hazard. It shall not require construction (no construction is defined as - no installation or removal of walls and floors, additional power (that requires re-wiring), plumbing (in wall or floor), HVAC or drains). Any construction that must be completed by an external vendor is not allowed. Projects that significantly modify existing resources or space is considered Construction and not allowed. Contractor shall be responsible for visiting and assessing, along with representatives from Laboratory, Bio-Med, and Clinical Engineering, the space/utilities available in each laboratory to determine specific site prep requirements including but not limited to: Space availability Power availability, including special receptacle requirements Other utility availability water, drains, etc., as required Increase heat load affecting air conditioning Specialized ventilation, if required Special finishes required Carts for non-floor standing instrumentation 9.6. The vendor shall remove all equipment within 45 days of the expiration of the term of this IRA but not until the completion of the new vendor s equipment installation inclusive of completed cross over studies. Each facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade/replacement. X. SECURITY INFORMATION 10.1. Contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the includes the use of common security configurations available from NIST s We Site at: https://checklists.nist.gov 10.2. To ensure that appropriate security controls are in place, Contractors must follow the VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site: http://www.iprm.oit.va.gov (End of Statement of Work) In response to this announcement, please provide the information below. If this information is not provided, then it will be assumed the entire requirement cannot be met: NAICS Code: 334516 Company Name: Address: UEI (Unique Entity ID) Number: Contact Name: Phone No.: Email: Business Size Information - Select all that applies: Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HUBZone Woman Owned Certified Service-Disabled Veteran Owned Small Veteran Owned Small Business Large Business FSS/GSA Contract Holder: Yes No FSS/GSA Contract Number: Effective Date/ Expiration Date: Proposed solution is listed and available on the above FSS/GSA Contract: Yes No Available pricing structure of proposed solution (select all that are applicable below): Pricing Model Please Indicate Availability Below: (Yes / No / NA) All on FSS Open Market only Mix of FSS & Open Market (CPRR) Cost Per Reportable Result Cost Per Test(CPT) Reagent Rental Agreement Equipment Rental with Reagent Purchase Fixed Monthly Charge Other: (Please explain) Federal Acquisition Regulation (FAR) Market Rearch Questions: Buy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a: Domestic end product? _____________ (%) Foreign end product? _______________ (%) Questions for Small Businesses ONLY: Limitations on Subcontracting (FAR 52.219-14) What percentage of the work would be subcontracted to another company? ________ If > 0, what is company s business size: __________ If subcontracting, what added value do you offer (FAR 52.215-23): _______________________________ Nonmanufacturer Rule (FAR 52.219-33): Does your company manufacturer these proposed items? [ ] yes [ ] no Does your company exceed 500 employees? [ ] yes [ ] no If yes, list # of employees: _________ Does your company primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied? [ ] yes [ ] no Does your company take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? [ ] yes [ ] no Does your company supply the end item of a small business manufacturer, processor or producer made in the United States, or obtains a waiver of such requirement pursuant to paragraph (b)(5) CFR 121.406. [ ] yes [ ] no If yes, what is the manufacturer s name? ________________ The information submitted shall contain the company s business size status. This is a request for information and sources only, which may or may not lead to a future solicitation. This is not a request for quote (RFQ). No questions will be answered. The VA will not pay for any information received resulting from this sources sought notice. Requests for copies of a solicitation shall not be honored or acknowledged. Information should be forwarded to the Contracting Officer. If your organization can provide all services of this potential requirement and is interested in this opportunity, please respond to Lindsey Zwaagstra, Lindsey.Zwaagstra@va.gov, Contracting Officer, Department of Veterans Affairs, NCO 19, 6162 S. Willow Drive, Suite 300, Greenwood Village, Colorado 80111 and NCO19lab@va.gov  with a statement describing your capabilities and completed table above. The capability statement shall include a point of contact, complete mailing address, telephone number, email address and state the company s business size status. The deadline for this information to be received is 15:00 PM Mountain Time, 10/29/2025.