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 sensitivity and specificity at no additional cost to the Government. 5. Contractor performs all of the statistical analysis for the instrument validation and report data in a format that meets regulatory requirements. 4. Service and Maintenance Contractor provides equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, covered under the delivery order/s award, and UPS. Support Services: Contractor provides telephone assistance 24-hours/day, 365 days per year with a call back response of 2 hours. Following determination that service is required, technical on site support provided under the terms of the contract and provided for emergency repairs 365 days per year within twenty-four (24) hours of the time of notification of the malfunction for medical center labs. For CBOC labs, during normal operating hours, within twenty-four (24) hours of the time of notification of the malfunction. If both primary and backup analyzers are not able to perform a test listed as STAT, Contractor has/have defined, approved contingency plan(s) to ensure continuation of testing. Contractor provides maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government will provide the Contractor access to the equipment to perform maintenance service according to the maintenance and service terms. Contractor to furnish a malfunction incident report to the installation upon completion of each repair call. The report includes, at a minimum, the following: (a) date and time notified; (b) date and time of arrival; (c) serial number, type and model number(s) of equipment; (d) time spent for repair; (e) description of malfunction and repair; and (f) proof of repair that includes documentation of quality control being performed and within range, as applicable. Notify the site management if repair is significant enough to require calibration and/or validation following the repair and Contractor performs calibration and/or validation. Maintenance plan: Contractor provides manufacturer s daily, weekly, monthly, quarterly and periodic maintenance plan, outlining time required for hands on and automated tasks. Daily maintenance: Instrumentation requires minimal hands-on daily maintenance. Preventative Maintenance: Contractor provides regular, scheduled maintenance coordinated with the site management to assure the continued reliable operation of the equipment. These preventive maintenance visits are of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment. Emergency Repair: Emergency repairs performed after notification that the equipment is inoperative. Contractor provides the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. Contractor performs emergency repair service within 24 hours of time of notification of the malfunction. Contractor provides all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the Contractor. Contractor furnishes a malfunction incident report to the installation upon completion of each maintenance call. The report includes, at a minimum, the following: (a) date and time of arrival. (b) Serial number type and model numbers(s) of equipment (c) time spent for repair, (d) description of malfunction and (e) proof of repair. Maintenance Support: Service repair person locally based within the geographical area. Maintenance Credit for Equipment Malfunction: If a machine remains inoperative due to a malfunction through no fault or negligence of the government for more than 24 hours, the Contractor is assessed damages at the rate of 1/30 of the preceding average three-month CPRR billings times the total number of days certified as downtime. Each incident starts from the time the user makes a bona fide attempt to contact the Contractor's designated representative at the prearranged contact point until the machine is returned to good operating order less any non-contracted maintenance (emergency repairs) days. Replacement of Laboratory Equipment: During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the Contractor. Failure Mean Time Disclosure: Contractor states the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Contractor to provide redundant systems to eliminate need of emergency backup equipment. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the Contractor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the Contractor performed within 60 days after request. 5. Training 1. Contractor provides 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 and minimally equivalent to the terms and conditions for training defined in this contract. This includes training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, Contractor provides training at a minimum for one operator per installed analyzer per year for the duration of the contract at the discretion of the Government for each model of instrumentation or automation placed. Utilization of the training slots will be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel includes the cost of airfare, room, and board for each participant. 2. Onsite Training: During the validation process of the installation, the Contractor provides technical resources to train operators on all shifts of operation. This can be accomplished by holding training sessions for multiple employees on each shift. 3. Additional training required: Advanced training, either off-site or in-house, provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization On-site refresher training in renewal option years of the contract made available annually for the duration of the contract. Contractor provides supplemental on-site operator training to government personnel, without additional charge to the government, upon installation of upgraded equipment hardware or operating system software connected with the operation of an instrument that has already been installed. 6. Upgrade/Updates Contractor provides updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of the-art technology, at no additional charge to the Government. Upgrades are provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system updates that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the delivery order/s; however, it does refer to significant changes in the hardware operational capability. Should any facility decide to upgrade their current equipment, i.e., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement. 7. Information Technology A VA Directive 6550 Appendix A completed for each analyzer offered under the solicitation. Primary and back-up instrument interfacing is required at all sites. The current type of interface system is Data Innovations. Contractor is responsible for providing all hardware and software licenses required for the connection, and implementation of the analyzer s interface to the Laboratory s Universal Interface. Contractor provides 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. Contractor provides any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g., electronic procedure manual Contractor has/have the 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. 8. Ancillary Support Equipment Contractor provides, installs, and maintains, as indicated, any and all ancillary support equipment to fully operate the analyzer or automation as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), compressed air, and universal interface equipment, UPS, etc. Contractor includes all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc. 9. Packaging and Marking 1. All supplies are adequately packaged to prevent damage during shipping, handling and storage. Bags or packages are whole, intact, and not otherwise torn or damaged. Contractor is required to replace unacceptable or damaged products at the Contractor s expense. 2. Items are marked clearly with the delivery order number, purchase order number, and delivery location within the hospital i.e., Laboratory Services/113. 10. Installation/Implementation PHASE-IN/PHASE OUT REQUIREMENTS - Due to the length of time required to implement the requirements. Phase-in requirements: The implementation of the services/requirements described in this solicitation shall be completed no later than 180 days or based on the mutually agreed upon timeline by the Contractor and VA after award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 180-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e., construction/ remodeling of facilities). Upon award, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be 120 days from the date of award through 180 days or based on the mutually agreed upon timeline by the Contractor and VA. This requirement includes the implementation of auto verification and the transmission of QC data to an external real-time QC service. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government. The new Contractor must be able to coordinate with the laboratory and install the new equipment while the old Contractor s equipment is still in operation in order to prevent any lapse of service for laboratory testing. At the end of 180 days from award of the Contract, the awarded Contractor has/have full and sole responsibility for services under the awarded delivery order/s. Phase-out Requirements:  During the phase-out period, the incumbent contractor(s) shall be fully responsible for all work performed under this Statement of Work (SOW). Up to one hundred eighty (180) calendar day phase out period may be required. The incumbent contractor(s) shall cooperate fully to permit an orderly changeover of laboratory workload. The incumbent contractor shall allow the new contractor and government personnel access on a non-interference basis, to observe the day-to-day operations and to become familiar with the work requirements and procedures. Within one week from the date of award, the CO, POCs and the Contractor will hold a kickoff meeting to discuss implementation. Acceptance and Performance This paragraph establishes a standard of quality performance that is to be met before any equipment listed on the delivery order/s is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period begins on the installation date. Acceptance will occur once the analyzers/equipment have met the standard performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as proposed in the contract at an effectiveness level of 90% or more. Start-Up Reagents - The Contractor provides all reagents, calibrators, controls, consumable items, 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. The 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, carryover studies, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests continues on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the Government may request a replacement or terminate the delivery order/s in accordance with the provisions of FAR 8.406-4 Termination for cause. (The Contractor will receive revenue for tests reported during the 90-day acceptance period.). Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident starts from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work required begins as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours will be used when in excess of the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of this paragraph and notifies the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime will be measured in hours and whole minutes. 11. Replacement of Malfunctioning Equipment During the term of the delivery order/s, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, will be solely that of the Contractor. Each instrument provided by the Contractor will maintain an uptime of 90% in each month of the term of the contract. 12. Delivery The Contractor will deliver all supplies and services identified in the schedule to the locations identified in Section 1.7. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Contracting Officer Representative (POC) will be required to notify the Contractor when delivery locations have been changed. All deliveries will be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip will be provided at time of delivery. The packages packing list/slip will contain the complete purchase order number, delivery order number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Standard orders will be delivered within no more than 4 working days after receipt or placement of order. Emergency deliveries may be necessary on rare occasions. During these occasions, deliveries will be made within one (1) working day if the order is place before 10:30 am. Otherwise, the emergency deliveries will be made no later than two (2) working days from the time the order was placed. Emergency deliveries will be made at no additional cost to the government. 13. Government s Responsibility The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user will maintain appropriate records to satisfy the requirements of this paragraph. 14. Ownership of Equipment Title to the equipment remains with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor will accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order/s, at termination and/or replacement of equipment, will remove the equipment at the expense of the Contractor. The Contractor will disconnect the analyzer (gas, water, air, etc.) and will be responsible for all packing and shipping required to remove the analyzer. 15. Equipment Removal Following the expiration of this contract, the Contractor will remove all equipment within 30 days after notification of the completion of new Contractor s equipment installation including cross over studies and approval for use for patient testing. 16. Invoice Information The following information will be listed on all invoice(s) (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor) Facility s Name and address where service was provided Delivery order number (For example: 36C26122NXXXX) Obligation number (For example: 570-C50001) A Line Item break down of usage for example: Line item 1 CBC CPRR: 10 ea. at $4.00 for a total of $40.00. Line item 4 Retic CPRR: 20 ea. at $10.00 Period of time that is being invoiced for in the invoice. Delivery order holder s internal contract number (if applicable) Point of contact for concerns and questions. Must name a specific person, phone number and email. One monthly invoice per purchase order number required (For example: VA570-C50001) The serial numbers of each analyzer. Note 1: Contractor to supply meter software training if meter software can be changed by the end user, if applicable. Note 2: Timely invoices are to be submitted to the acceptable government system with 30 calendar days following the period of service. Note 3: No invoices can be generated until after successful installation and user reporting the go live date to generate patient results for clinical application. 17. Hours of work Service is generally performed during normal work hours. If a work stoppage occurs due to failure of backup systems, emergency after hours service will be required. Holidays. Only emergency services are provided on National Holidays and only if authorized by the POC in advance. New Year s Day January 1st Martin Luther King s Birthday Third Monday in January President s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th When a National Holiday falls on a Sunday, the following Monday is observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday. 18. Requirements While Working at VISN 21 Facilities The Contractor s employees approved by the POC will wear visible identification at all times while on the premises of the facilities within the NCO. Identification will include but not be limited to a company identification card, including the company name, employee name, title, and a photograph of the employee. Contractor Employees will maintain a professional appearance commensurate to their industry. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. This will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Any interior or exterior doors that are unlocked to gain access are to be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices will be locked immediately upon entry or exit. At no time will the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies. Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a contractor badge prior to contacting the POC. The Contractor's staff will also be required to sign in and out each day at a designated location determined by the POC. Some sites may require contractor staff to register in a Contractor s system. Smoking is prohibited inside any buildings at facilities within NCO 21. Possession of weapons is prohibited. Enclosed containers, including tool kits, are subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. The Contractor will not allow his/her employees, including Subcontractors employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor is responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government is not obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work. Contractor personnel will follow all local infection control measures. 19. Waste Characterization of waste: The Contractor will provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation will include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. The determination and description will address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4) The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor will fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. The Contractor will use/connect to drain lines for the removal of liquid waste. For safety reason, no dis-assembly of equipment by laboratory personnel will be required to dispose of waste. Contractor to provide a description of all waste that the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 is required to be determined and documented. Any mercury containing reagents are required to be identified in any concentrations. All test results are to be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 are required to be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosol and formaldehyde) are to be developed and SDS sheets will be provided in advance for review. At a minimum, documentation is to include, but not be limited to the concentration/measures of the elements and parameters listed below and included with Contractor response: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200°F) BOD; biochemical oxygen demand The documentation the Contractor provides will be used to work with the VA and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system. (End of SOW)
