Inactive

Subject: Sources Sought, Chemistry & Immunoassay CPRR Equipment and Tests for the VA Central California Healthcare System (VACCHCS) located at 2615 E Clinton Ave, Fresno, CA 93703-2233. The purpose of... Subject: Sources Sought, Chemistry & Immunoassay CPRR Equipment and Tests for the VA Central California Healthcare System (VACCHCS) located at 2615 E Clinton Ave, Fresno, CA 93703-2233. The purpose of this sources sought is to conduct market research to support the procurement of Chemistry & Immunoassay CPRR Equipment and Tests for the VA Central California Healthcare System. This notice serves to survey the market in an attempt to ascertain whether or not sources are capable of providing the requested supplies. This notice allows potential vendors to submit a non-binding statement of interest and documentation demonstrating their capability. The sources sought effort is intended to assess industry capabilities and develop/support the intended direction of acquisition planning. The Network Contracting Office (NCO 21) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 334516 Analytical Laboratory Instrument Manufacturing. This sources sought is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, or large business) relative to NAICS 334516. Responses to this notice, will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a solicitation announcement may be published. Responses to this notice are not considered adequate responses to any corresponding solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this notice. Background: The Department of Veterans Affairs (VA), VACCHCS has a requirement for Chemistry & Immunoassay CPRR Equipment and Tests. Refer to the included Statement of Work and attached requirements (P09 Chem IA_SOW Attachment A Volume Estimates). Instructions: Submit a brief description, two-three (2-3) pages (including cover letter) that demonstrates how your company can provide the requested supplies that are required. Include past experience in providing this system to the VA, other Government (Federal or State) agency, or for a private facility. Please specify your availability and your address. PLEASE INDICATE WHETHER YOU HOLD A GSA FEDERAL-SUPPLY SCHEDULE CONTRACT THAT COVERS THESE SERVICES AND, IF SO, THE CONTRACT NUMBER. Provide BUSINESS SIZE AND SOCIO-ECONOMIC STATUS; (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantages business (c) If disadvantages, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the UEI number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and/or the VetCert Registry at Veteran Small Business Certification (sba.gov). If not, please NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry (i) provide current commercial pricing and any applicable discounts. (j) link to the respondent s General Services Administration (GSA) schedule, or attached file of same, if applicable (k) citation of any current or past customers (i.e., within the past two (2) years) to include contract number, point of contact telephone number or e-mail address; and (l) other material relevant to establishing core competencies of the firm. Response is due by 12:00 PM Pacific Time, Wednesday, May 29, 2024. Please submit e-mail responses to Mr. David J. Alvarez, Contracting Officer, at email address: david.alvarez4@va.gov and Mrs. Tawnya Krommenhoek at email address: tawnya.krommenhoek@va.gov. Your response should include a STATEMENT OF CAPABLILITY, GSA SCHEDULE INFORMATION, UEI#, BUSINESS SIZE, AND SOCIO-ECONOMIC STATUS information as explained above. Please place Attention: Chemistry & Immunoassay - VACCHCS in the subject line of your email. This notice is to assist the VA in determining sources only, questions will not be received at this time. NOTES: Issuance of this notice does not constitute any obligation whatsoever on the part of the Government to procure these services, or to issue a solicitation, nor to notify respondents of the results of this notice. No solicitation documents exists at this time; however, in the event the acquisition strategy demonstrates that GSA is a viable option for procuring a solution, the RFQ shall be posted to GSA eBuy where only those firms who currently hold a GSA Schedule with the applicable SIN will be able to respond. The Department of Veterans Affairs is neither seeking quotes nor accepting unsolicited quotes, and responses to this notice cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative costs incurred in response to this sources sought notice. Statement of Work (SOW) INTRODUCTION VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM has a requirement for a Cost Per Reportable Results (CPRR) Indefinite Delivery, Indefinite Quantity (IDIQ) contract for clinical laboratory and immunoassay analyzers. The contractor agrees to provide a price schedule with Cost Per Reportable Results (CPRR) Pricing structures only, in accordance with the terms and conditions of the SOW to the Veterans Integrated Service Network 21 (VISN 21), identified as the Government herein. The services and prices are specified in the sections entitled Schedule of Supplies/Services of this contract. Period of Performance: 5-year ordering period with five one-year pricing periods. The proposed period of performance is: Base Year: October 1, 2024 September 30, 2025 Ordering Period 1: October 1, 2025 September 30, 2026 Ordering Period 2: October 1, 2026 September 30, 2027 Ordering Period 3: October 1, 2027 September 30, 2028 Ordering Period 4: October 1, 2028 September 30, 2029 Place of Performance: The scope of this contract covers the entire area of responsibility (AOR) of VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM, including any clinic. The Government may add onto this IDIQ for any Community-Based Outpatient Clinic (CBOCs), clinics, etc. 1.1 Participating Facilities: STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM VA Central CA Healthcare System 2615 E. Clinton Ave Fresno, CA 93703 1.2 VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM has provided estimated volumes of tests performed in Attachment A Volume Estimates and Individual Test Pricing for each individual medical center and outpatient clinic laboratory. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed. Volumes may fluctuate up or down during the term of the IDIQ. Types of Analyzers at each location: LOCATION Chemistry Immunoassay Automation STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM   Fresno, CA 93703 X X 2. Required Specifications 2.1 General The desired instrumentation will have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrumentation will be able to perform the profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (Hereafter referenced as CLIA) and the Clinical and Laboratory Standards Institute (Hereafter referenced as CLSI). Equipment will be new, state of the art, and not recertified nor refurbished. Equipment will be acquired for each of the clinical laboratories located at VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items will be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Unexpected changes in methodology/technology will be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the appropriate and local point of contact (Hereafter referenced as POC). These individuals will be identified upon award of the delivery order/s. Special Handling for Emergency Orders of Supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor will deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. Industry Standards Unless otherwise stated, all equipment will be held to current industry standards for such equipment as present within the current market for Chemistry, Immunoassay, and automation equipment, supplies and services. Only instruments which are FDA approved will be considered. Instruments will be operational and must interface with VA Laboratory Computer systems and upgrades. Test methods will be FDA approved. 2.2 Definitions Cost-Per-Reportable-Result (CPRR) Contractors are required to provide a price for a reportable patient result. The per reportable result price will include costs covering (a) equipment use, (b) all reagents, standards, 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 of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price will also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by National Committee for Clinical Laboratory Standards (NCCLS). (c) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. Clinical Laboratory Chemistry Analyzer - Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human chemistry testing. Clinical Laboratory Immunoassay Analyzer Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human immunoassay testing. Primary analyzer(s) Base equipment offered that will fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s), likewise, be considered primary instrumentation, and will be compatible with the primary analyzer, and meet the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer will be equivalent to a back-up analyzer (see definition below) and replace the requirement for offering that category of equipment. Back-up analyzer(s) Equipment required to support the operations of the NCO laboratories when the primary analyzer(s) is not operational/functional. However, this equipment may also be used in conjunction with the Primary Analyzer to meet NCO program requirements as determined by the NCO, such as but not limited to the simultaneous operation of both instruments to run additional testing as needed to meet program requirements. This category of equipment must be capable of operation during periods of time when the primary instrumentation is not available for use. The back-up analyzers will be of the same model as the Primary Analyzers to allow the facility to continue operation at appropriate levels. Business Associate Agreement (Hereafter referenced as BAA) -¬ A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with everyone that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Community Based Outpatient Clinic (Hereafter referenced as CBOC) CBOC s are smaller facilities with smaller throughput than their larger parent facilities. Specific CBOC laboratories with test volumes listed in Attachment A Volume Estimates and Individual Test Pricing will require equipment placements. 2.3 Chemistry Instrumentation: The instrumentation capabilities: 1 Provide clinical chemistry analyzer(s) with sufficient capacity and throughput to meet the volume demands as defined in the Test Menu (Attachment A Volume Estimates and Individual Test Pricing. 2 Provide chemistry analyzers with consistent assay test methodologies for the purpose load balancing (workload) and back up purposes as indicated in the equipment list. 3 Closed Tube Sampling Capability. De-capping or close-tube sampling capability. The system should have access to cap-piercing or pre-analytical de-capping, and automated recapping of sample tubes for storage if required by the facilities. 4 Test menu identified in Attachment A Volume Estimates and Individual Test Pricing. Secondary or backup analyzer(s) specified to be manufactured by the same Contractor receiving the award and use(s) the same reagents for each test to allow for standardized test builds. Using third-party analyzer(s) to meet test menu requirements is not acceptable. Using third-party equipment for automation is acceptable. Third party open channel assay on contractors solution is acceptable. 5 Analyzer to have automation and front-loading capabilities. 6 Systems should prioritize automation. Sites with an automation line should have both chemistry and immunoassay systems connected to the automation line. Sites without an automation line should provide chemistry and immunoassay systems that are connected and integrated. 7 Walkaway capability. Reagents proposed for each analyzer must ensure that there is at least 24 hours of operational time before requiring replacement. 8 hours is acceptable for electrolytes, as long as the QC task is automated. 8 On board automatic dilutions with no technologist intervention or be able to automatically extend the dynamic range of the assay without technologist intervention. 9 Large onboard reagent capacity. The chemistry analyzer must have an onboard reagent capacity to perform test volumes listed on the Test Menu (Attachment A Volume Estimates and Individual Test Pricing with a minimal amount of reagent swapping. A minimal amount of reagent swapping is defined as less than 5 assays in the menu on Attachment A Volume Estimates and Individual Test Pricing. The onboard capacity reagent volume should support a 24-hour walkaway capability. 10 Be space efficient and can be installed within the existing floor space square footage with proper egress for safety. The equipment proposed must accommodate workflow to ensure easy access to other parts/departments of the laboratory. Relocated equipment within the laboratory space must stay within the same room. Affixed equipment means equipment affixed or anchored to real property or requiring dismantlement for relocation. 11. Perform the creatinine, hemoglobin A1C and cholesterol assay testing using a method referenced to an international standard (e.g., WHO standard). If the methodology changes and warrants patient re-baselining, the Contractor to provide necessary services and materials. 12 Analyzer to have minimal reagent preparation. 90% of reagents, calibrators, and controls are to be liquid and ready-to-use with minimal to no equilibration time from storage prior to use on the analyzer. 13 Have the capability to add additional assays as they become available. 14 Must use Ion Selective Electrode (ISE) technology for the measurement of electrolytes. An enzymatic method for CO2 will be acceptable if an ISE method is not available. 15 Be capable of flagging expiring reagents and calibrations. Must allow quality control (QC) data viewing and report extraction (e.g., Levey Jennings charts, running means & SD s, etc.), have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting. 16 Have bidirectional interface capabilities. 17 Have a minimum of 20 facilities reporting in peer groups for QC programs and the College of American Pathologists (CAP) Proficiency Test Program. Ability to export and upload QC data in real time to peer group program. 18 Analyzer to have the capability to perform serum indices, defined as the qualitative assessment of lipemia, icterus, and hemolysis. 19 Ability to detect fibrin or clots and short samples during sample aspiration. 20 Ability to generate Critical and/or abnormal result flags. 21 Analyzer has/have test methods and/or procedures equivalent to standard reference methods, with high preference for international standardization when possible. 22 Ability to accept multiple tube sizes, such as 13X100mm, 13X75mm, 16X100mm. 23 Each analyzer or data manager has/have the ability to store and retrieve patient data for at least 30 days. 24 Have the ability to prioritize STAT testing over routine testing with the least amount of technologist intervention. 25 Contractor to maintain an adequate replacement part inventory locally to minimize downtime associated with transporting parts to analyzer site. An adequate inventory would include parts that are known/could need to be changed frequently and should be kept either on-site or locally in a storage facility. Sufficient parts for routine maintenance to be kept onsite. 26 If the analyzers require a water system, the Contractor to install and maintain an appropriately sized water system for the duration of the contract at the Contractor s expense. Maintaining an existing system is also acceptable. The water system is to provide an acceptable quality and quantity of water to the analyzers according to the required specifications. 27. Equipment provide(s) an Uninterruptible Power Supply (UPS). If possible, provide a single UPS with the capacity to maintain continuous operations for 30 minutes allowing for a controlled shutdown or to shut-down the instrument in an orderly manner in the event power outage. 28. The contractor has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation. Calibration frequency not to exceed once per 24 hours per instrument for ISE. Ability for long calibration stability for all other testing. Ability to pre-calibrate new lots of reagents prior to use. Quality control testing requirement frequency not to exceed once per 24 hours per instrument. Ability to lock out/suppress test analytes if there are QC failures. No requirements for sample pre-treatment. Test volumes are listed by facility in Attachment A Volume Estimates and Individual Test 2.4 Immunoassay Instrumentation The instrumentation capabilities: Provide immunoassay analyzers with consistent methodology for load balancing (workload) and back up purposes as indicated in the equipment list. Secondary or backup analyzer(s) specified to be manufactured by the same Contractor receiving the award and use(s) the same reagents for each test to allow for standardized test builds. Third-party analyzer(s) to meet test menu requirements is not acceptable. Using third-party equipment for automation is acceptable. Third party open channel assay on contractors solution is acceptable. 2 Ability to aspirate the sample and release the tube, so additional testing can be run without delays. 3 Perform the Prostate Specific Antigen (PSA) assay testing with consistency for patient testing using the hybritech method or the WHO standard with optional free PSA. If the methodology changes warrant patient re-baselining, the Contractor to provide necessary services and materials. 4 Provide analyzer(s) with sufficient capacity and throughput to meet the volume demands as defined in the Test Menu (Attachment A Volume Estimates and Individual Test Pricing. 5 Systems should prioritize automation. Sites with an automation line should have both chemistry and immunoassay systems connected to the automation line. Sites without an automation line should provide chemistry and immunoassay systems that are connected and integrated. 6 The analyzer to be able to connect to the provided data management system along with the Chemistry analyzers in order to consolidate lab test results and allow the ability to schedule repeat testing directly from the Data Management System. 7 Each analyzer or data manager has/have the ability to store and retrieve patient data for at least 30 days. 8 Analyzer and or data management system has/have Reagent and Control lot monitoring capabilities. 9 Be capable of flagging expiring reagents and calibrations. Allow(s) quality control (QC) data viewing and report extraction (e.g., Levey Jennings charts, running means & SD s, etc.), has/have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting. 10 The analyzer onboard reagent storage accommodates the tests specified on the data usage spreadsheet (Attachment A Volume Estimates and Individual Test Pricing). 11 The analyzer has/have bidirectional interface capability. 12 The analyzer contains electronic trouble shooting software for instrument errors. 13 Analyzer has/have minimal reagent preparation and equilibration. 90% of the Contractor s reagents are to be fully liquid and ready to use without reconstitution. 14 Analyzer has/have Fibrin and/or clot detection, in addition to short sample detection. 15 Has/have Critical and/or Abnormal result flagging. 16 Analyzer provide(s) an Uninterruptible Power Supply (UPS). 17 Analyzer has/have test methods and /or procedures equivalent to standard reference methods. 18 Contractor maintain(s) an adequate replacement parts inventory locally to minimize downtime associated with transporting parts to analyzer site. A listing will be provided to the facility upon request. 19 If the analyzers require a water system, Contractor installs and maintains an appropriately sized water system for the duration of the contract at the Contractor s expense. Maintaining an existing system is also acceptable. The water system is to provide an acceptable quality and quantity of water to the analyzers according to the required specifications. 20 Assays will have demonstrated advantages in the avoidance or mitigation of interferences from both endogenous interferences, (e.g., Rheumatoid Factor, and Alkaline Phosphatase), pre-analytical interferences (e.g., hemolysis, lipemia, and icterus), and exogenous interference from supplements and common pharmaceuticals (e.g., biotin). 21 Analyzers capable of performing a wide range of infectious disease testing. Including, but not limited to HIV, Hepatitis B, and Hepatitis C testing for sites requiring on-site testing (refer to attachment A), and without managing multiple immunoassay contracts to provide this testing. Provide solutions for STAT turnaround time on Immunoassay testing. Immunoassay incubation times not to exceed 30 minutes, to meet or exceed current turnaround times. A Troponin which meets the IFCC definition of high sensitivity i.e., can be detected in at least 50% of normal reference population. State carryover claim and design solutions to mitigate carryover. 2.5 Power for Chemistry and Immunoassay: 1. Individual components require no more than 30 amps, 110V or 220V. It is acceptable for peripheral equipment such as the monitor, computer, and printer, to be plugged into separate outlets or UPS. 2. Provide back-up UPS power for each analyzer/component. 3. Installed within the existing power capability that exists for each laboratory, regarding both emergency and normal power. 2.6 Automation for Chemistry and Immunoassay: 1. Analyzers capable of adding automation connectivity for future requirements during the term of the delivery order/s. Any additions will be negotiated and require the signature of the CO and delivery order/s contract holder. 2. The automation system will perform centrifugation, sorting, and load balancing to the analyzers, decapping, recapping or sealing the specimen, and placing the specimen into a refrigerated storage unit. It is preferable but not required that an automated specimen disposal feature is available 3. Ability to store a minimum of 5000 or more samples in an online refrigerated storage unit for more than 24 hours. Add on test requests will be processed with the refrigerated storage unit reintroducing the sample back on the line for testing with minimal operator intervention. 4. The Automation centrifuge must have adequate Relative Centrifugal Force (RCF) to accommodate a six minute or less centrifugation time to provide sufficient separation of serum or plasma from its cellular constituents for testing with analyzers connected to the automated track or if taken off the track for testing or to be sent out to a referral lab. 5. Specimens to be mapped by the automation software to allow quick automated retrieval from the refrigerated storage unit. 6. Automation and analyzers to be installed within the existing floor space with proper egress for safety. Relocated equipment within the laboratory space must stay within the same room. Affixed equipment means equipment affixed or anchored to real property or requiring dismantlement for relocation. 7. Ability to simultaneously accept pre-spun and non-spun samples for processing, optional spin status detection of samples. 8. Automation system compatible with the chemistry and immunoassay instrumentation selected on this solicitation. The automation system process(es) those samples with the required tests listed on Attachment A for both Chemistry and Immunoassay. 9. Provide and install a suitable compressed air system sufficient for the automation system if needed. 10. Automation includes input sorting technology (such as a hopper) and the ability to aliquot. 11. Has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation. 12 Ability to make bar code labeled aliquot tubes that mirror the primary tube labeling for offline processing. 13. De-capper has/have the ability to remove different cap types (e.g., hemogard, screw caps, rubber stoppers). This is necessary to maintain employee safety by reducing the exposure to body fluids and maintain workflow and turnaround time. 14. Uncapping and recapping/sealer system in an enclosed environment to prevent distribution of bio- hazardous aerosols. 2.7 Data Management for Chemistry and Immunoassay: 1. The Data Manager will display real-time list of pending results that can be sorted by STAT vs. Routine. 2. Ability to consolidate lab test results from Chemistry and Immunoassay testing analyzers and transmit the consolidated results to the Lab Information System. 3. Monitor Quality Control Results for all connected instruments. 4. Has the capability to perform real-time moving averages and stop patient result uploading if QC or averages exceed established limits. 5. Ability to perform rerun testing or add on testing thru the Data Management system. 6. Ability to install validation rules for auto validation purposes on Contractor middleware. 7. Has remote display and interaction with analyzers for operations, to include error messages and reagent inventories. 8. Updates to Data Management software are provided at no additional charge when they become available. 9. Provide license(s) and hardware if needed for Data Innovations or other middleware at no additional charge to the VA. 10. Capability to establish a remote connection for the purpose of instrument troubleshooting, reagent management, software updates, and delivering test volumes for invoice generation. Has/have an ISA/MOU is established with the VA OI&T (Office of Information and Technology) to allow for the implementation of remote diagnostics connectivity. All connectivity hardware and installation is provided by the Contractor. 11. Listed as preferred but not required: Will automatically calculate and report to the LIS both Free and BioAvailable Testosterone, using values from Total Testosterone, Albumin, and Sex Binding Globulin Hormone. 12. Has/have the capability to transmit QC data to an external real-time QC service. 2.8 Software for Chemistry and Immunoassay: 1. Has/have QC monitoring software. 2. Has/have online help and maintenance tracking capabilities and have service/downtime record for troubleshooting information. 3. Software upgrade(s) compatible and require no or minimal changes to existing Laboratory Information System (LIS) 3. Installation/Site Preparation: 1. Site preparation specifications for each facility to be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery order/s. The report to be provided to the Contracting Officer no later than one week after award of the delivery order/s and all other site reports to be provided at least forty-five (45) days before installation. All proposed equipment should fit in the available lab space square footage with proper egress for safety. Relocated equipment within the laboratory space must stay within the same room. Affixed equipment means equipment affixed or anchored to real property or requiring dismantlement for relocation. 2. Equipment will be new, state of the art, and not recertified or refurbished. 3. Start-Up Reagents. The Contractor provides all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the contract and required to establish instruments for operation for performance of acceptance testing. 4. Contractor performs, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of s...