6640--CPRR AUTOMATED CLINICAL URINALYSIS INSTRUMENT

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-02 published in the Federal Register on December 22, 2023. This solicitation is for Full and Open competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516, with a small business size standard of 1,000 employees. The FSC/PSC is 6640. The Bruce W. Carter VA Medical Center - Miami Veterans Healthcare System 1201 NW 16th Street - Miami, FL 33125 is seeking to award a Firm Fixed Price Base Plus Four Option Years Contract for CPRR (Cost Per Reportable Result) Automated Clinical Urinalysis Instrument. All interested companies shall provide quotations for the following: Supplies/Services Item Number Description Quantity Unit of Measure Unit Price Amount 0001 Chemistry Tests Contract Period: Base Pop Begin: 4/1/2024 Pop End: 9/30/2024 27375 EA     0002 Microscopy Tests Contract Period: Base Pop Begin: 4/1/2024 Pop End: 9/30/2024 12000 EA     0003 Microscopy Tests Digital Imaging Unit Contract Period: Base Pop Begin: 4/1/2024 Pop End: 9/30/2024 10065 EA     1001 Chemistry Tests Contract Period: Option 1 Pop Begin: 10/1/2024 Pop End: 9/30/2025 54750 EA     1002 Microscopy Tests Contract Period: Option 1 Pop Begin: 10/1/2024 Pop End: 9/30/2025 24000 EA     1003 Microscopy Tests Digital Imaging Unit Contract Period: Option 1 Pop Begin: 10/1/2024 Pop End: 9/30/2025 20130 EA     2001 Chemistry Tests Contract Period: Option 2 Pop Begin: 10/1/2025 Pop End: 9/30/2026 54750 EA     2002 Microscopy Tests Contract Period: Option 2 Pop Begin: 10/1/2025 Pop End: 9/30/2026 24000 EA     2003 Microscopy Tests Digital Imaging Unit Contract Period: Option 2 Pop Begin: 10/1/2025 Pop End: 9/30/2026 20130 EA     3001 Chemistry Tests Contract Period: Option 3 Pop Begin: 10/1/2026 Pop End: 9/30/2027 54750 EA     3002 Microscopy Tests Contract Period: Option 3 Pop Begin: 10/1/2026 Pop End: 9/30/2027 24000 EA     3003 Microscopy Tests Digital Imaging Unit Contract Period: Option 3 Pop Begin: 10/1/2026 Pop End: 9/30/2027 20130 EA     4001 Chemistry Tests Contract Period: Option 4 Pop Begin: 10/1/2027 Pop End: 9/30/2028 54750 EA     4002 Microscopy Tests Contract Period: Option 4 Pop Begin: 10/1/2027 Pop End: 9/30/2028 24000 EA     4003 Microscopy Tests Digital Imaging Unit Contract Period: Option 4 Pop Begin: 10/1/2027 Pop End: 9/30/2028 20130 EA     Grand Total: The following Statement of Work is required to meet the needs of the government. STATEMENT OF WORK REQUEST FOR TWO (2) AUTOMATED CLINICAL URINALYSIS INSTRUMENT INCLUDING A CHEMISTRY MODULE, MICROSCOPY MODULE AND A SEDIMENT DIGITAL IMAGE IDENTIFICATION GENERAL: The Bruce W. Carter Miami VA HealthCare system has a need for a Urinalysis solution able to integrate Urine Chemistry, Microscopic Particle Counting and Digital Imaging on a single automated line to comply with the needs of our growing veteran population. This system shall have two (2) Chemistry modules, two (2) Particle counting modules and at least one (1) Digital Imaging module. Tests shall be Food and Drug Administration (FDA) approved. All materials and services are to be calculated as a cost per reportable result (CPRR) and shall be billed once per month. The CPRR program shall include the equipment, service and maintenance, training, all reagents, controls, calibrators, consumables, reagent strips, calibration strips, cleaning solutions, diluent solutions, and any fluid solution necessary to operate the contractor s equipment. The contract shall include a BASE (6 months) with an option to renew for four (4) additional years. SCOPE: The Contractor shall provide all the necessary instrumentation, on-site and off-site employee training, preventive maintenance, repairs, parts, emergency and routine service, hot line services, upgrades, all the necessary software, reagents, controls, calibrators, linearities, correlation materials, disposables, consumables, other required supplies (such as tables for the analyzers, printers and PCs for the urinalysis systems, UPS for each instrument and other items required for optimal system performance ) for in-house urinalysis testing in the Pathology & Laboratory Medicine Service (PLMS) at the Bruce W. Carter Miami VA Healthcare System (MVAHS) as outlined below. All work shall be performed in accordance with the guidelines established by Federal, State, and local ordinances, Food and Drugs Administration (FDA) manufacturer's guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein. TERM OF CONTRACT/PERFORMANCE PERIOD: The period of performance is a BASE (6 months) plus 4 years with the BASE year starting on 04/01/2024 with Four (4) option years going through 09/30/ 2028. Supplies associated with this contract will be shipped on Standing Order basis, all other items will be ordered as needed: Base Year : 04/01/24 to 09/30/24 Option Year 1: 10/01/24 to 09/30/25 Option Year 2: 10/01/25 to 09/30/26 Option Year 3: 10/01/26 to 09/30/27 Option Year 4: 10/01/27 to 09/30/28 APPLICABLE DOCUMENTS: The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply: FAR Federal Acquisition Regulation VAAR Veterans Administration Acquisition Regulation GLOSSARY: Acronyms used in this SOW are listed below for easy reference: CAP College of American Pathologists CLIA Clinical Laboratory Improvement Act CFR Code of Federal Regulations COR Contracting Officer s Representative CPTR Cost Per Test Result CPRR Cost Per Reportable Result FAR Federal Acquisition Regulation FDA Food and Drugs Administration FSS Federal Supply Schedule PM Preventive Maintenance SOW Statement of Work UPS Universal Power Supply VAAR Veterans Administration Acquisition Regulation VISTA Veterans Health Information Systems and Technology Architecture PERFORMANCE REQUIREMENTS: Clinical Requirements: The system shall be able to integrate Urine Chemistry, Microscopy and Digital Imaging module. The system shall be able to provide at least one redundant instrument for each module (Chemistry, Microscopy, and Digital Imaging Unit). The system shall provide true walkaway final results with minimal tech intervention for the re-classification of urine particles. Automated Urine Chemistry module shall: Include chemical analysis of urine to include color, clarity, specific gravity, pH and the presence/absence of leukocytes esterase, nitrites, total protein, glucose, blood/hemoglobin, ketone, ascorbic acid, urobilinogen, and bilirubin. Vendor shall have a protocol to ensure strip integrity. Have automatic color correction to reduce false positive due to dark urines (bilirubin). Have a continuous feed of strips/cassettes without operator intervention and at least 2-week on-board stability. Able to process more than 100 samples/hour. Strips or cassettes shall have a loading mechanism to reduce misalignment or strip jams. Automated Urine Microscopic/ Digital Imaging shall: Include analysis to determine the presence/absence of sediment constituents, such as but not limited to red blood cells, white blood cells, casts, crystals, bacteria, etc. Have a technology that provides differentiation of particles that contain nucleic acid from particles that do not contain nucleic acids with minimum tech intervention. Be able to display particle images to provide high confidence in the classification of such elements. Be able to automatically detect presence of crystals and differentiate between similar sized particles. Have a system to address the presence of amorphous urates and phosphate crystals that allow the specimen to be processed without needing manual microscopy. Have a reagent/technology to eliminate mucus interference. Require minimal operator intervention to review or reclassify images. Provide state of the art digital images and auto particle recognition software that provides the most extensive and accurate quantification of urine particles and rigorously tested and accurate urine chemistry assays. The system shall have special technology that provides reliable, precise, and accurate urine particle differentiation and count. Include digital imaging which yields microscope-quality images with accurate sediment classification and cell ID for fewer screen review. Have a particle detection down to <0.5um to facilitate enhanced bacteria detection. The system shall allow the sample to be used for additional testing (no substances introduced into the sample). The system shall be barcode driven, random access, and have a precision delivery system. The system shall include editable onboard rules that automate reflex testing from urine chemistry to urine particle counting, and also form urine particle counting to confirmatory urine particle digital imaging. The system shall be capable of rules based resulting of which the operator is notified when incongruent results are reported between the urine chemistry analyzer and the urine microscopy analyzer. The systems shall deliver well established, standout performance on proficiency surveys. The system shall have automatic reportable parameters such WBC, RBC Epithelial cells, casts, and bacteria that are FDA approved in order to reduce tech interaction. Reduced carryover with user adjustable carryover rinse cycle settings to eliminate interference. The Urinalysis system shall provide analytical measurements range for WBC and RBC that are clinically relevant with minimum dilution requirements and operation intervention. The system shall be easily standardized with accurate particle differentiation, bacteria quantification, and enhanced detection down to <0.5 um. The system shall strive to eliminate manual microscopy and provide unmatched quality and accuracy. The system shall come with a cart or continuous bench top area, and capable of housing reagents for the primary analyzers. The system shall have minimal maintenance <30 minutes with walkaway capability and minimize staff hands-on and free technologists for more critical tasks. The system shall not require monitoring during a run and shall be 100% walk-away system (load-and-go), with minimal reclassification of urine particles. Contractor shall provide quality control material at a minimum of two levels: normal and elevated/abnormal levels. The system shall be LIS compatible with Vista and Data Innovations. The system shall come ready for Auto verification of negative results. The system shall suspend or turn off the Auto verification process automatically upon QC failures or QC time limits are exceeded. All models shall perform satisfactorily at any laboratory temperature between 59- and 86° F (15 and 30° Celsius). All models shall perform satisfactorily at any laboratory relative humidity between 30 - 80%. An electronic operator s manual shall be furnished with each model supplied. ANCILLARY SERVICES: Site Preparation: Specifications shall be provided in writing by the contractor as 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 manufacturer s claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which involve additional expense to the government, shall be made at the expense of the contractor. Training: The contractor shall provide training classes including operation, user-performed maintenance, troubleshooting for 2 operating personnel for each instrument. Training shall be provided on-site and/or off-site for all designees and shall occur prior to the start of testing. On-site training by the contractor shall be provided to all staff as needed. Contractor to provide the training plan and credentials summary of trainers with proposal. On-site training of designated personnel shall include: operation and care of instrument, techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation and troubleshooting of equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of equipment failure. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment. If training for key operators requires travel, arrangements to an off-site location will be paid and arranged by the Contractor. Ownership of Equipment: Ownership of equipment shall remain with the contractor. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of orders at termination and/or replacement of equipment, will remove the equipment. The contractor will be responsible for decontamination, disconnecting, packing, and shipping of the equipment. Service, repairs, and maintenance to be provided Monday to Sunday, 365 days a year. All service, repairs, and maintenance to be performed by the vendor. Vendor repair staff will need to be on-site within 24 hours or less after notification of instrument downtime. Contractor retains ownership of instruments and will ensure that at least one blood cell analyzer is operational at all times. Parts replaced during service will be removed or disposed of by the vendor. Vendor to provide a hazardous waste determination with the proposal. Contractor shall submit all FDA recalls and incidents issued and/or reported on the analyzers, reagents, and control products. Vendor will provide list of references at the local and national level. Vendor shall list any reagents or other items that the VA will be responsible to purchase that are not included in the CPRR pricing. INSTALLATION: The contractor shall be responsible for installation which consists of in-house delivery, positioning, and mounting of all the equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Installation of instrumentation will be provided at no cost to the government. Contractor will provide all parts, labor, supplies, reagents, calibrators, linearity materials, disposables and consumables and will ensure proper operation of instruments. Vendor will provide project management to assure that the installation is coordinated with VA and vendor staff. Instrumentation shall be compatible with Data Innovations middleware currently in use as well as being able to interface with Vista. Upon receipt of notice to proceed with installation, it is expected that the contractor has the system installed within a 30-day period from time of delivery. Delays: Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed. Upon completion of installation, the equipment will be turned over to the laboratory for use. Final acceptance of the equipment and installation will be based upon an inspection and test result acceptability within thirty (30) calendar days from date of installation as noted above. Contractor to provide calibration and assisted calibration verification and set up reference ranges during validation studies. Contractor to provide any ancillary printers, monitors, computers, and scanners required by the system to provide a printed or electronic report. MAINTENANCE: Preventive Maintenance (PM): The Contractor shall perform preventive maintenance (PM) at intervals specified by the manufacturer to ensure proper equipment performance. The Contractor shall test all components for proper test performance. After PM, the contractor shall submit a detailed work report to include all required materials and labor at no additional cost to the Government. Delivery of PM parts or material: The contractor shall provide all preventive service materials at no additional cost to the government. On-call Repairs: On-call repairs are emergency repairs beyond the scheduled Maintenance and will be provided at no additional cost to the government. The contractor shall provide technical assistance not limited to test performance, or equipment malfunction twenty-four (24) hours a day, seven (7) days a week, all Federal and religious holidays, via direct communication thru a telephone bank with technically capacitated and contractor-certified personnel. Emergency Repairs: The contractor shall respond to routine calls for on-site repair and be at the job site within twenty-four (24) hours during regular working hours, Monday Sunday, 7:30 am 4:00 pm. The contractor shall respond to emergency calls for on-site repairs within eight hours or less. After repair, the contractor shall submit a detailed work report to include all required labor, materials, and parts at no additional cost to the Government. The contractor shall provide the ability to troubleshoot via phone. Service phone call backs shall be done within 1 hour. Delivery of repairs parts or materials: The contractor shall provide all parts and materials at no additional cost the government. Travel, per diem and other expenses associated with the repair will be the responsibility of the contractor. The Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to and not limited to repairs, replacements, recall, and upgrades at no additional cost to the Government. Safety: The Contractor shall immediately notify the Government of any changes in reagents kits composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulations. Test Performance: All tests and procedures shall comply and be approved by FDA. All test, procedures and equipment shall perform at manufacturer s specifications. Deviations from the performance specifications shall be corrected by the contractor. All test performance will be evaluated by and not limited to performance thru peer comparison, quality control and CAP peer evaluation according to CLIA regulations. A technical support specialist provided by the contractor will perform all validation studies including: Installation and setup Correlation studies for each test: a minimum of 20 samples spanning the reportable range shall be run by the present and proposed method (evaluation and comparison data sufficient to satisfy JC standards). Precision study using normal and abnormal control material (which at least 10 normal and 10 abnormal controls. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive and false negative rate are applied. Carryover studies shall be completed by the contractor in all analyzers during installation. Linearity according to manufacturer s specifications. Reference range study: samples shall be representative of the patient population being tested. All studies shall be completed within two weeks of installation. Operator procedure manuals shall be furnished for each instrument model supplied. Contract: Cost per Reportable Results(CPRR): contractors are required to provide a provide a price for each test that can be performed in its equipment. The Cost per Test price shall include costs covering (a) equipment use, (b) all reagents, controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test results, (c) all necessary maintenance to keep the equipment in good operating condition. PERFORMANCE LOCATION AND HOURS: The Department of Veterans Affairs Medical Center, Pathology & Laboratory Medicine Service, 1201 NW 16th Street, PLMS Room A305 Miami, Florida, 33125. The Government normal duty hours are from 7:30 am - 4:00 pm, Monday through Friday, excluding Federal holidays and weekends. The MVAHS PLMS Main Laboratory is the primary location and provides diagnostic support to the facility and outpatient clinics 24 hours a day, 7 days per week. DELIVERABLES: The contractor shall deliver all equipment, software, hardware, PCs, printers, ribbons/cartridges, and UPS necessary for test performance at no additional cost to the Government. The contractor shall deliver all and not limited to operational, maintenance, troubleshooting, repairs, parts, equipment specifications and tests manuals. The contractor shall install the equipment and perform test verification according to manufacturer specification, CLIA, FDA and CAP requirements. The contractor shall deliver all necessary reagents, calibrators, controls, disposables, and consumables according to the terms and conditions of this contract. In the event that the requested supplies are on back-order, the contractor shall inform the COR as to the estimated time of availability. Vendor will decide so critical materials are provided to prevent testing interruption and subsequent failures in patient care. The contractor shall deliver all invoices with the term of service included-- for review according to the established contract at the end of each monthly billing cycle. All items not covered under this contract shall be specifically detailed on the invoice including description, quantity required, and government cost. Invoices shall contain all the necessary information for proper processing. The contractor shall immediately notify the COR of any changes in reagents or equipment modifications by electronic as well as by postal mail with supporting documentation of the change and, detailed guidance against implementation within twenty-four (24) hours of its application or according to FDA guidelines. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation and/or any other additional cost shall be covered by the contractor at no additional cost to the Government. CONTRACTOR PERSONNEL AND MANAGEMENT: Contractor Personnel: The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this SOW. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. Government Badges: The COR will coordinate through the Security Service Sponsor/Managers the issuance of required visitor badges to Contractor personnel. Contract personnel shall wear identification badges provided by the Government at all times when performing work on-site. Badges shall be worn on the outer garment, attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard. Government issued identification badge remains the property of the Government and shall be returned to the issuing office or other designated Government personnel upon transfer of Contractor employees from the contract. Contractor Badges: Notwithstanding the requirement to wear a Government furnished badge, Contractor personnel shall also wear a contractor identification badge at all times when performing services under this Contract, including when on Government directed travel. The badge will contain a personal picture, name of employee, and Contractor's name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard. Safety/Security Requirements: The Contractor shall comply with all applicable federal, state, and local laws and ensure performance is secure while protecting material, equipment, and supplies from damage and loss. Government security personnel shall have the express right to inspect for security violations at any time during the term of the contract. All information generated in performance of this contract becomes property of the Government and shall be surrendered upon request and/or completion of the contract. The Contractor shall protect against the destruction and/or misplacement of all information produced under this contract, unless directed under local policy to destroy. This includes both hard and soft copies of data. The Contractor shall not release any information (including photographs, files, public announcements, statements, denials, or confirmations) on any part of the subject matter of this contract or any phase of any program hereunder without the prior written approval by the hospital director or designated representative. Standards of Conduct: Conduct of Personnel. Contractor personnel shall always conduct themselves in a professional manner (i.e., timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of the Government. The hospital director or designated representative has the authority to bar individuals from the Government facility. The removal from the job site or dismissal from the premises shall not relieve the Contractor of the requirement to provide sufficient personnel to perform the services as required by this Statement of Work. The Government shall not reimburse the Contractor for travel and other expenses associated with the removal of personnel. Contractor personnel are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract. Working Attire and Appearance. Contractor personnel shall present a professional appearance commensurate with standards delineated for Government civilian personnel acting in similar capacities. The Government reserves the right to review Contractor personnel qualifications. Upon request, resumes shall be provided to the Contracting Officer prior to clearance approval, for review and acceptance by the COR. The intent is for verification purposes and not for the Government to become the hiring authority. NON-PERSONAL SERVICE STATEMENT: Contractor employees performing services under this order will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in the SOW. Contractor employees will perform their duties independent of, and without the supervision of, any Government official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work. NON-PERSONNEL SERVICE STATEMENT: The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this SOW. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements. The work history of each contractor employee shall contain experience directly related to the task and functions he/she is intended to perform under this contract. The Government reserves the right, during the life of the resulting contract, to request work histories on any contractor employee for the purposes of verifying compliance with the above requirements; additionally, the Government reserves the right to review resumes of contractor personnel proposed to be assigned. Personnel assigned to, or utilized by, the Contractor in performance of work shall be fully capable of performing the requirements contained in the SOW in an efficient, reliable, and professional manner. The normal manner of dress is business casual. Specific Personnel Qualifications Requirements Personnel assigned to or utilized by the contractor in the performance of this contract shall, as a minimum: Be qualified by the contractor as capable to perform as a field service representative. Specialized Experience: The Contractor shall provide technical guidance to Supply Operations customers concerning supply requirements; provide logistical technical assistance to civilian personnel of all units, elements and activities assigned to, or stationed in the South Florida area; ensure adherence to management, administrative, operational, and safety requirements of the DOL standard operating procedures; ensure that internal control checklists are prepared and submitted to meet established suspense dates and that corrective actions are completed within acceptable timeframes. PERFORMANCE STANDARD AND QUALITY MEASUREMENT: Performance standards define desired services: The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL). The Quality Assurance Surveillance Plan (QASP) method of surveillance will be by random inspection. Performance Evaluation: After acceptance of the contract, the system will be monitored for equipment performance including but not limited to; safety (recall Notifications and changes in reagents and equipment notifications), quality assurance (emergency repair response, hot line troubleshooting response, quality of results compared to peer groups and CAP survey performance) and documentation (invoice accountability and invoice verification, equipment specification and user manuals), customer satisfaction (response to complaints and laboratory employees training). The QASP and its performance objectives are as follows: Task Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Safety Recall Notification Timely recall notification of reagent and supplies. 100%-98% Monthly monitoring Exercise of Option Period and past performance. Changes in reagent and equipment modifications. Timely distribution / notification of 100%-98% Direct Observation Exercise of Option Period and past performance. Quality Assurance Emergency Repairs Within 24 hours <2 Repairs per quarter per equipment. 100% Monthly monitoring Exercise of Option Period and past performance. Troubleshooting via phone. Immediate response 100%-98% Monthly Monitoring Exercise of Option Period and past performance. Successful reporting of results Repeat runs are minimal 95% Direct Observation, Quality control reports run as needed. Exercise of Option Period and past performance. Successful Peer group comparison CAP survey performance 95% Direct Observation CAP survey reports Exercise of Option Period and past performance. Performance Daily QC Less the 5 failures per month 100% Monthly monitoring Exercise of Option Period and past performance Consumable supplies Furnish all consumables supplies required for proper operation 100% Direct observation Exercise of Option Period and Past Performance Documentation Invoice Accountability Monthly invoices 100% Invoices received through OLCS via Austin, Texas. Invoices include the month and year being billed. Exercise of Option Period and past performance. Invoice Verification Monthly invoices 100% Invoices contain all necessary information for proper processing. Exercise of Option Period and past performance Equipment specifications and user manuals Provided prior to delivery of equipment. 100% Up to date information supplied by vendor as changed. Exercise of Option Period and past performance Customer Satisfaction Substantiated complaints from lab users 1 complaint per quarter 100% Reports of contacts or other documentation. Exercise of Option Period and past performance Training of laboratory personnel Provided upon activation of new system and training of new recruits upon request 100% Reports of contacts or other documentation. Exercise of Option Period and past performance The information identified above is intended to be descriptive, not restrictive, and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. Delivery shall be provided no later than 30 days after receipt of order (ARO) FOB Destination. Should the line items not be available within that time period, please specify an estimated delivery date. Place of Performance/Place of Delivery Address: Bruce W. Carter VA Medical Center Miami VA Healthcare System 1201 NW 16th Street Miami, FL Postal Code: 33125-1624 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services (Nov 2023) FAR 52.211-6, Brand Name or Equal (Aug 1999) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (Nov 2023) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (Nov 2023) Grey market items are Original Equipment Manufacturer (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts) for VA Medical Centers. No remanufactures or grey market items will be acceptable. The delivery of grey market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or grey market item(s) delivered to a VA medical facility upon discovery of such items. Reference VAAR 812.3 regarding Grey Market and Counterfeit Items. Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. Offerors providing an or equal product(s) must adhere to the terms in FAR 52.211-6. If an item in this solicitation is identified as brand name or equal, the purchase description reflects the characteristics and level of quality that will satisfy the Government s needs. The salient physical, functional, or performance characteristics that equal products must meet or exceed are specified in the solicitation. To be considered for award, offers of equal products, including equal products of the brand name manufacturer, must Meet the salient physical, functional, or performance characteristic specified in this solicitation; Clearly identify the item by- Brand name, if any and Make or model number, Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. The contracting officer will evaluate equal products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the contracting officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. Unless the offeror clearly indicates in its offer that the product being offered is an equal product, the offeror shall provide the brand name product referenced in the solicitation. Any award made as a result of this solicitation will be made on an All or Nothing Basis. State if quoted items are available and priced through offerors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA- wide Acquisition Contract. If the acquisition is set-aside for SDVOSBs/VOSBs, their socioeconomic status must be VIP verified and visible in the VA Vendor Information Pages (VIP): https://www.vip.vetbiz.gov/ at the time of quote submission AND award, or will be considered non-responsive, and will NOT be considered for award. Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations. All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments, or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. All quoters shall submit the following with the quote or the quote will be considered non-responsive, and will NOT be considered for award: The name, address, and telephone number of the vendor. Tax Identification Number (TIN) SAM UEI Number / DUNS Number / Cage Code Point of Contact for submission of orders if awarded a contract Authorized Distributor Letter certified by the OEM if the offeror is not the manufacturer Quoted price shall include delivery If applicable - VAAR 852.219-76 (Limitations on Subcontracting) must be completed and signed. (Clause inserted below: A.2 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (NOV 2022) ) All quotes shall be sent to the following email address: melissa.everett@va.gov . Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. ADDENDUM to 52.212-2 Evaluation Commercial Products and Commercial Services Basis for Award. The Government will issue a purchase order to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical capability or quality of the item offered to meet the Government requirement Price Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following: Factor 1: Technical capability or quality of the item offered to meet the Government requirement: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation. Factor 2: Price: The Government will evaluate the price by adding the total of all line item prices. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet or exceed the technical capability or quality of the item offered to the Government requirement, as stated in Factor 1, shall not be selected regardless of price. Factor 3: Past Performance - The government may rely on internal documentation including PPIRS and contracting officer s knowledge of and previous experience with supply or service being acquired for determining Past Performance. If no record of past performance is found, the offeror shall not receive a favorable or unfavorable rating but shall receive a rating of neutral. (End of Provision) The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR. The following provision is incorporated into 52.212-1 as an addendum to this solicitation: FAR 52.212-1 Instructions to Offerors Commercial Products and Commercial Services (Nov 2021) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the Request for Quote (RFQ). However, the small business size standard for a concern that submits a quote, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees if the acquisition Is set aside for small business and has a value above the simplified acquisition threshold; or Uses the HUBZone price evaluation preference regardless of dollar value, unless the quoter waives the price evaluation preference; or Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value. Submission of Quotes. Submit signed and dated quotes to the office specified in this Request for Quote (RFQ) at or before the exact time specified. Quotes may be submitted on letterhead stationery, or as otherwise specified in the RFQ. As a minimum, quotes must show The solicitation number; The time specified in the solicitation for receipt of quotations; The name, address, and telephone number of the quoter; A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary; Terms of any express warranty; Price and any discount terms; "Remit to" address, if different than mailing address; A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the quoter shall complete electronically); Acknowledgment Request for Quotation amendments; Past performance will not be considered in simplified acquisition procurements. Quote should include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotes that fail to furnish required representations and certifications, information requested in (1) to (9), and accept the terms and conditions of the solicitation may be excluded from consideration. Period for acceptance of Quotes. The quoter agrees to hold the prices in its quote firm for 30 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the solicitation. Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of quotes. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender s request and expense, unless they are destroyed during testing. Multiple Quotes. Quoters are encouraged to submit multiple quotes presenting alternative line items (provided that the alternative line items are consistent with FAR subpart  4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each quote submitted will be evaluated separately. Late submissions, revisions, and withdrawals of quotes. Quoters are responsible for submitting quotes so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that quotes are due. Any quotation received at the Government office designated in the solicitation after the exact time specified for receipt of quotes is "late" and may not be considered unless it is received before purchase order issuance and the Contracting Officer (CO) determines that accepting the late quotation would not unduly delay the acquisition. If an emergency or unanticipated event interrupts normal Government processes so that quotations cannot be received at the Government office designated for receipt of quotes by the exact time specified in the solicitation, and urgent Government requirements preclude a notice of an extension of the closing date, the time specified for receipt of quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. Issuance of Purchase Order. The Government may issue a purchase order to one or more quoters as identified in the Request for Quote (RFQ). Therefore, the quoter s initial quote should contain the best terms from a price and technical standpoint. However, the Government may reject any or all quotes if such action is in the public s best interest. The Contracting Officer (CO) may issue a purchase order to other than the quoter with the lowest priced quotation. Multiple awards. The Government may issue a purchase order for any item or group of items of a quotation, unless the quoter qualifies the quotation by specific limitations. Unless otherwise provided in the Schedule, quotations may not be submitted for quantities less than those specified. The Government reserves the right to issue a purchase order for a quantity less than the quantity quoted, at the unit prices quoted, unless the quoter specifies otherwise in the quotation. Availability of requirements documents cited in the solicitation. (i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to- GSA Federal Supply Service Specifications Section Suite 8100 470 East L Enfant Plaza, SW Washington, DC 20407 Telephone (202) 619-8925, Facsimile (202) 619-8978. (ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee. Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites: (i) ASSIST ( https://assist.dla.mil/online/start/). (ii) Quick Search ( http://quicksearch.dla.mil/). Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by- (i) Using the ASSIST Shopping Wizard ( https://assist.dla.mil/wizard/index.cfm); (ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or (iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462. Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance. Unique entity identifier (UEI). Applies to all quotes that exceed the micro-purchase threshold, and quotes at or below the micro-purchase threshold if the solicitation requires the contractor to be registered in the System for Award Management (SAM).) The quoter must enter, in the block with its name and address on the cover page of its quote, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the quoters name and address. The quoter also must enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the UEI. The suffix is assigned at the discretion of the quoter to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart  32.11) for the same entity. If the quoter does not have a UEI, it should contact the entity designated at www.sam.gov for UEI establishment directly to obtain one. The quoter should indicate that it is a quoter for a Government contract when contacting the entity designated at www.sam.gov for establishing the UEI. [Reserved] Requests for information. The CO will not notify unsuccessful quoters that responded to this Request for Quotation (RFQ). However, quoters may request information on purchase order(s) resulting from this solicitation with the CO. (End of Provision) To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than 4:00 PM Eastern Standard Time (EST) on February 22, 2024, at melissa.everett@va.gov and shall reference RFQ 36C24824Q0559 CPRR Automated Clinical Urinalysis Instrument in the subject of the email. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below by 1:00 PM Eastern Standard Time (EST) on February 15, 2024. Point of Contact Contract Specialist Melissa Everett melissa.everett@va.gov A.2 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (NOV 2022) (a) Pursuant to 38 U.S.C. 8127(k)(2), the offeror certifies that (1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: (i) [ ] In the case of a contract for supplies or products (other than from a nonmanufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not VIPlisted SDVOSBs as set forth in 852.219 73 or VOSBs as set forth in 852.219 74. Any work that a similarly situated VIP-listed subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted. (ii) [ ] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR 121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act. (2) Manufacturer or nonmanufacturer representation and certification. [Offeror fillin check each applicable box below. The offeror must select the applicable provision below, identifying itself as either a manufacturer or nonmanufacturer]: (i) [] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United States, in accordance with paragraph (a)(1)(i). (ii) [ ] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required in order to qualify as a nonmanufacturer. [ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18). [ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied. [ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice. (3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution. (4) If VA determines that an SDVOSB/ VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following: (i) Referral to the VA Suspension and Debarment Committee; (ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and (iii) Prosecution for violating section 1001 of title 18. (b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed. (c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate. (d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award. Certification I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror]. Printed Name of Signee: ___________ Printed Title of Signee: _____________ Signature: ____________ Date: ______________ Company Name and Address: _______________ (End of Clause)