The Amarillo VA Health Care System (AVAHCS) in Amarillo, Texas is seeking Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or Small Business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB, or Small Business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than 4:00 PM Central Time, August 17, 2021. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov. Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope. DISCLAIMER This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE: 1. GENERAL INFORMATION 1.1. Title of Project: Integrated General and Immunoassay Chemistry 1.2. Scope of Work: The Chemistry Department of the Pathology and Laboratory Medicine Service (P&LMS), under the direction of the Amarillo Veterans Affairs Health Care System (AVAHCS), will enter into a cost-per- reportable result (CPRR) contract for chemistry and a CPRR immunoassay testing at our primary location in Amarillo, TX and a secondary location in Lubbock, TX. The CPRR contract pricing shall include all costs associated with instrumentation, reagents, consumables, calibrators, quality control materials, water filtration system, uninterrupted power supplies, service, parts, training, shipping, middleware, interfacing, installation, and validation studies for the two combined clinical chemistry departments running approximately 1.35 million chemistry and immunoassay tests per year. 1.3. Background: The Chemistry Department of the Amarillo VAHCS is a 24/7/365 operation that services the Amarillo area and the 50 surrounding countries in the Texas/Oklahoma Panhandle, New Mexico, and a small portion of Colorado. Amarillo VAHCS has a large outpatient population who visit the Hospital each day, and the four Community-Based Outreach Clinics (Lubbock, TX; Childress, TX; Dalhart, TX and Clovis, NM). Currently, the Amarillo and Lubbock Chemistry Department runs approximately 100 analytes, has approximately 500+ tubes per day come through the Department, with an annual combined estimated testing volume of approximately 1.35 million tests. For the past 12 years, the Chemistry Department located in Amarillo, TX has utilized 2 chemistry analyzers and 2 immunoassay analyzers, and Infectious disease testing analyzer. The Lubbock CBOC has 2 chemistry analyzers, 2 immunoassay analyzes and 1 Infectious disease analyzer. With the procurement of this new contract, the AVAHCS P&LMS is seeking to add new instrumentation and an expanded middleware solution, at both locations in Amarillo and Lubbock, TX. 1. 4. Performance Period. 1.4.1 See Price/Cost Schedule 1.5. Type of Contract: 1.5.1 This is a firm fixed price contract. 1.5.2 All reagents, calibrators, and consumables are Indefinite Delivery/Indefinite Quantity (ID/IQ) and shall be delivered upon the ordering facility and/or metering data. 1.5.3 The Contractor must provide all equipment, reagents, calibrators, controls, consumable items, parts, accessories, ancillary devices, service plans, shipping costs, installation, validation studies, training, any other item required to establish instrument operation, and should be from the same family of analyzers as applicable and suitable for the facilities listed. 1. 6. Place of performance 1.6.1 Thomas E. Creek Amarillo VA Health Care System Pathology & Laboratory Medicine Service/113 6010 Amarillo Blvd., West Amarillo, TX 79106 806-355-9703 Ext. 7510 1.6.2 Lubbock Community Based Outpatient Clinic (CBOC) 3510 4th Street Lubbock, TX 79415 806-355-9703 Ext. 7510 2. GENERAL REQUIREMENTS FOR CHEMISTRY EQUIPMENT/ANALYZERS 2.1 Instrumentation shall be from the same family of analyzers as applicable and suitable for the facilities listed. 2.2 The equipment models being offered shall be in current production as of the date this proposal is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Consideration of used equipment or current in-house equipment will not be accepted in the proposal. 2.3 The Contractor shall provide all upgrades to the equipment hardware and operating system software at no additional cost to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market. 2.4 All components instrumentation, middleware, and reagents shall be compatible with each other. All components shall be manufactured with the purposeful intent of being utilized operationally with each other. 2.5 All components instrumentation, middleware, and reagents shall be Food and Drug Administration (FDA)-approved. 2.6 Instrumentation and reagents shall be able to perform tests to specifications as defined by CLIA and CLSI standards, including satisfactory CAP peer group comparisons. 2.7 Sufficient capacity and throughput to meet the volume and service demands as defined. 2.8 To be configurable to perform automatic on-board dilutions of all samples with out of range results or defined limits are exceeded. 2.9 Capability to program a test as a repeat with interfacing of results to overlay initial result. 2.10 The ability to continuously load patient specimens. 2.11 Be an open system which can accommodate at least 8 or more user-defined assays with the ability of incorporating other manufacturer s reagents 2.12 The ability to detect short samples and have clot detection with alert notification prior to the sample entering the probes. 2.13 Capable of primary tube sampling from various manufacturers and sizes of evacuated tubes. 2.14 Accept serum, plasma, urine, cerebrospinal fluid, and other body fluids. 2.15 Ability to handle all routine sample collection tubes plus other various sized sample containers i.e., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts. 2.16 Proven to have zero to minimal patient sample carryover. 2.17 Proven to have zero to minimal interfering factors that would affect the test results (such as hemolysis, lipemia, icterus, drug interference, etc.) 2.18 Have a reagent pipetting system, and cuvette decontamination protocol (if permanent/semi- permanent cuvettes are used), which guarantees there is no reagent carryover interference with other on-board assays. 2.19 Have the ability to quantify, at least semi-quantitatively, serum indices. This includes hemolysis, icterus, and lipemia. Indices should be reported as 1+ to 4+ and have respective bias information corresponding to this interference in the assay package inserts. 2.20 Ability to prioritize STAT testing without compromising existing programmed testing. 2.21 Minimal operator intervention to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run. 2.22 Be able to have calibration testing and quality control testing performed without excess delay to testing currently in progress. 2.23 The instrument systems shall have on-board reagent refrigeration. 2.24 The instrument systems shall have on-board, adjustable, color, touchscreen monitors that are easily readable and icon driven and user friendly. 2.25 The Contractor shall provide all necessary printers for the instrument systems and shall be responsible to replace/repair any broken instrument system printers over the life of the contract. (supplies such as paper, cartridges/ink will be the responsibility of the Government) 2.26 The Contractor shall provide all upgrades to the equipment hardware and operating system software at no additional cost to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market. 2.27 All required water systems, primary and backup, to supply deionized water for chemistry analyzers (including consumable polishers, filters, preventative maintenance and repair) is the responsibility of the Vendor. 2.28 Safety features to avoid unnecessary exposure to biohazardous and chemical material. 2.29 Total equipment footprint and the installation of the automation line when installed in the laboratory shall not impact the functionality/operations of laboratory. 2.30. Interface Requirements 2.30.1 The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system. 2.30.2 The Contractor shall provide all necessary software support for insuring 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. 2.30.3 If a site already has a universal interface system, the Contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. 2.30.4 If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. 2.30.5 If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. 2.31 Equipment/Analyzer Software 2.31.1 Trigger automatic repeat testing of critical samples. 2.31.2 Trigger reflex testing based on user-definable rules. 2.31.3 Allow for manual add-on testing of samples already loaded onto the instrument and/or automation line. 2.31.4 Track the processing of individual samples; to estimate the completion time of each analyte and to review any completed results on a patient sample, even if all analytes are not yet completed. 2.31.5 Display snapshot screens of patient testing queue, patient results, reagent status, calibration history, and quality control results. 2.31.6 Show real-time on-board reagent inventory. 2.31.7 Alert user of low reagent volumes at user-definable thresholds. 2.31.8 Store calibration curves for at least four different lot numbers per analyte. 2.31.9 Allow the operator to choose between multiple reagents, including multiple lots and Multiple containers of the same lot, to decide which to calibrate. 2.31.10 Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration. 2.31.11 Transfer and archive patient results, calibration history, and quality control records onto external media, such as a CD/DVD disk or an external hard drive. Once archived, the on-board memory shall be able to be purged so that the operator can manipulate only the current dataset accumulating since the most recent archive date. 2.31.12 Store and re-transmit patient records, in case of interface downtime up to a minimum of 24 hours or longer. 2.31.13 View Operations Manuals and Troubleshooting Guides on the instrument monitor with pictures, diagrams, and video. 2.31.14 Program sample batch processing. 2.31.15 Track and store which tests were performed on which specific instrument(s), per patient result. 2.31.16 Ability to monitor instrument performance. 2.31.17 A bi-directional, bar-coded computer interface compatible with the VA laboratory information system. The interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. 2.31.17.1 INTERFACE Transfer of data is bidirectional and will occur in the following manner: DAWNING / INNOVATION VISTA (LIS) INSTRUMENT 2.31.17.2 The following data fields will be collected: Prime ID Specimen ID Patient ID Priority Action code Sample type Collect data Collect time Creation date Creation time Last name First name Middle name SEX Birthday Location Analyzer Station Test name 2.31.17.2 Data is transferred from VISTA to a Dawning Secure Network Interface (SNI) device, which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the SNI which then sends the result back to VISTA in the appropriate format. 3.31.17.3 All testing is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access and verify codes. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks in locked drawers behind locked doors) per regulations. Data will be available to providers using CPRS system. 2.31.18 Barcode reading accuracy must have less than a 1.0 % failure rate. Must have positive patient identification with barcode verification at analyzer 2.31.19 Bar coding of reagents and the ability to track reagent containers throughout the testing process. 2.31.20 Contractor shall collaborate with lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity. 2.31.21 Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow. 2.31.22 An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc.,) Each UPS must provide electrical power for a minimum of 15 minutes or longer after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. Contractor is responsible for maintaining UPS systems provided. 2.31.23 Quality Control Program 2.31.23.1 Define multiple lots of the same control for simultaneous testing. 2.31.23.2 Perform quality control testing on all available lots and containers of a specific reagent when that reagent is selected for quality control analysis. 2.31.23.3 This should be automatic and not by manual selection. 2.31.23.4 Allow the operator to select which Westgard rules to apply. 2.31.23.5 Utilize weighted means and moving averages. 2.31.23.6 View and print daily, weekly, and monthly quality control results. 2.31.23.7 Document out-of-range quality control values. 2.31.23.8 Capability to record, store and print required quality control Levy- Jennings graphs., instrument maintenance information, patient demographic information and specimen results. 2.31.23.9 Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor. 2.31.23.10 Quality control material will automatically be run on all lots of those reagents when the respective test is requested. 2.31.23.11 Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor. 2.32 Reagent, Consumable, Quality Control Material & Calibrator Requirements 2.32.1 All reagents, buffers, substrates, controls and calibrators required to run all assays shall be included in the cost-per-reportable-result proposal and shall not be listed as individually priced line items. 2.32.2 Reagents shall be liquid, ready-to-use. Reagents shall minimally or not at all, require reagent preparation, including reconstitution/hydration, mixing components, and/or thawing/warming. 2.32.3 Reagent kits must be available in multiple kit sizes. 2.32.4 All consumables required to operate the instrument systems for the Amarillo VAHCS and Lubbock CBOC test menu assay-required consumables, shall be included in the cost-per-reportable-result proposal and shall not be priced separately. 2.32.5 All Amarillo VAHCS and Lubbock CBOC test menu assay-required calibrators shall be included in the cost-per-reportable-result proposal and shall not be priced separately. 2.32.6 Calibration(s) of on-board reagents per lot number should have a minimum stability of two (2) weeks or longer. 2.32.6 All Amarillo VAHCS and Lubbock CBOC test menu assay-required vendor manufactured quality controls shall be included in the cost-per-reportable -result test proposal and shall not be priced separately. This does not include 3rd party quality control materials. 2.32.7 All freight charges are the responsibility of the Vendor. 2.32.8 The contractor shall provide the specific deliverables described within the performance period stated in Section 1.4.1 The instrumentation and tests offered shall be approved by the Food and Drug Administration (FDA) 2.32.9 Specific Assay Requirements 2.32.9.1 The HIV assay shall be an automated 4th generation HIV Ag/Ab combination assay, which shall be performed on the same instrument system as all other immunoassay tests. 2.32.9.2 The HCV assay shall be an automated 4th generation assay, which shall be performed on the same instrument system as all other immunoassay tests. 2.32.9.3 Cardiac testing: The Amarillo VAHCS and Lubbock CBOC currently utilizes a high sensitivity Troponin I assay and BNP assay. The preference of the Amarillo VAHCS and Lubbock CBOC medical staff is to continue with high Sensitivity Troponin I and BNP. Switching to high sensitivity troponin T or NT pro-BNP is not an option. 2.32.9.4 Cortisol shall show no cross-reactivity with dexamethasone. 2.32.9.5 Tumor markers (such as Prolactin and Beta HCG) shall not exhibit a hook effect (prozone effect). 3. CHEMISTRY COST PER REPORTABLE RESULTS TEST MENUS 3.1 Amarillo Test menu and Optional Test menu 3.1.1 Refer to Attachment A 3.1.2 Optional Testing menu Refer to Attachment B 3.2 Lubbock Test menu and Optional Test menu 3.2.1 Refer to Attachment C 3.2.2 Optional Testing menu; there is not one. 3.3 Item quantities are Cost Per Reportable Results estimates per year and to be delivered IDIQ. Orders will be placed as needed by laboratory staff and/or by metering data. 4. ENVIRONMENTAL FACTORS AND UTILITIES REQUIREMENTS 4.1 The heat output of the automation and instrument system components, while operating at maximum capacity, and in conjunction with each other, shall be taken into consideration. 4.2 No piece of equipment shall have a noise output of more than 68 decibels when that equipment is performing at maximum operation. 4.3 Hazardous Waste The Contractor shall provide hazardous waste determination. The Hazardous Waste Determination is a procedure used to determine whether the by-products (liquid and solid waste) of an analytical process are characterized as a hazardous waste. 4.4 The solid waste created by the use of the proposed Contractor s materials shall be taken into consideration. This includes reagent boxes and wrappers, emptied reagent containers, and used consumable products 4.5 208/220V outlets are limited in the Chemistry Department of the Amarillo VAHCS and Lubbock CBOC. Consideration shall be given to the number of 208/220V outlets required for the automation components and instrument systems. 4.6 Compressed Air (if required for the operation of the automation line) 4.7 The Contractor shall be responsible for the installation costs of a water filtration system(s). 4.7.1 The Contractor shall be responsible for the costs of replacing, moving, modifying, or reinstalling the existing water filtration system in the Chemistry Department at the Amarillo VAHCS and Lubbock CBOC if required. 4.7.2 The water filtration system shall be comprised of at least two filtration units, including individual pumps, which can be operated in tandem or isolated, in the event one unit is contaminated or broken. 4.7.3 The water filtration system shall be sufficient to meet the maximum hourly water requirements of all instrument systems connected to it. 4.7.4 The water filtration system shall make Type II laboratory-grade water, meeting the manufacturer s requirements for the instrument systems. 4.7.5 The water filtration system shall have a reservoir tank of at least 250 liters. This volume may be shared among multiple water filtration systems. 4.7.6 The water filtration system shall utilize pre-treatment filters, due to the age of the Amarillo VAHCS and on-going projects to replace the facility s water lines. Lubbock CBOC has all new water lines. 4.7.7 The water filtration system shall have leak detection alarms, both audible and visible, and shall have bypass options to isolate individual filtration units. 4.7.8 The water filtration system shall have a spigot or tap, where another laboratory departments can fill up transport containers of filtered water. 4.8 The radio frequency tracking shall not cause harmful interference to other equipment or communications in the facility. . 5.0 System Management 5.0.1 Computer interface compatible with the current VA laboratory information system and existing universal interface. 5.0.2 The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. 5.0.3 Barcoding stations located at key points along the line or track system must have the following capabilities: 5.0.3.1 The accuracy of the barcode reading must have less than a 1.0 % failure rate. 5.0.3.2 Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. 5.0.3.3 Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently. 5.0.4 The ability to detect processing errors and provide error notification. 5.0.5 The ability to isolate primary analyzers from the processing equipment when necessary. 5.1 Middleware System-: Generally, a separate component/computer that electronically links the testing instrumentation to manage data, results and workflow (Not to be confused with Data Innovations or Remisol). 5.1.1 The Contractor shall specify where the middleware solution resides on a Amarillo VAHCS and Lubbock CBOC network or on a Contractor-provided PC/network. 5.1.2 The Contractor shall input initial validation rules and auto-verification rules as requested by the Amarillo VAHCS and Lubbock CBOC upon initial set-up. 5.1.2.1 The middleware solution shall have the capability to create user-definable rules. 5.1.2.2 The middleware solution shall be able to calculate and provide Moving Averages on patient testing data. 5.1.2.3 Instrument connection to middleware service shall be provided 5.1.3 The Contractor shall provide on-going middleware support to the Amarillo VAHCS and to the Lubbock CBOC for the life of the contract 5.1.3.1 This support shall include assistance with writing future rules, editing and troubleshooting. 5.1.3.2 The Contractor shall provide specific training to three (3) Amarillo VAHCS personnel and two (2) Lubbock CBOC on how to create and edit rules, how to configure and manipulate the middleware program, and how to troubleshoot problems with the middleware solution. 5.1.3.3 Training on-site or at an off-site location, all costs associated with the training shall be included in the proposed cost-per-reportable result proposal. 5.1.4 The Contractor s middleware solution shall have a successful history of interface with the Veteran Affair s VISTA Laboratory Information System. 5.1.5 The middleware solution shall have a history of successful connectivity to the Bio-Rad Unity Real-Time (URT) program, for purpose of transmitting daily quality control results to the URT s database. 5.1.6 The Contractor shall provide software updates to the middleware solution as part of the cost-per-test contract proposal. 6. TRAINING REQIREMENTS 6.1 The Contractor must provide an instrument(s) training program that is coordinated with and timely to the equipment installation. 6.2 Initial training to include one (1) operator per analyzer(s) and will include training on the operation of the system, data manipulation, and basic troubleshooting and repair. 6.3 Utilization of the training slots will be mutually agreed upon between the Amarillo VAHCS and Lubbock CBOC and the Contractor. 6.4 Additionally, the Amarillo VAHCS and Lubbock CBOC is requesting four (4) training slots specific to the middleware solution offered in the proposal either to be on-site or off-site. 6.5 A training program that involves off-site travel shall include the cost of airfare, ground transportation, room and board, and training/classroom costs for each participant. 6.6 The Contractor shall also provide in-house training for all laboratory shifts during implementation. 7. BILLING AND INVOICING 7.1 Monthly billing and test report summaries shall begin on the first day of the month and include the last day of the month. 7.2 VA-FSC shall require the following information in compliance with the Prompt Pay Act and Business Requirements. 7.2.1 Your Tax Payer ID number (TIN) 7.2.2 Your Remit Address information 7.2.3 The VA Purchase Order (PO) number 7.2.4 Your contact information: (Personal name, Email, and Phone) 7.2.5 Your VA Point of contact information (Personal name, Email, and Phone) 7.2.6 The Period of Performance dates (POP Beginning and Ending) 7.2.7 All discount information if applicable (Percent and Date Terms) 7.2.8 Reagents used with pricing per unit 7.2.9 No freight charges to be added to the invoice 7.3 Department of Veterans Affairs Financial Service Center: 7.3.1 Phone:1-877-353-9791 7.3.2 Email: vafscched@va.gov 7.4 AVAHCS shall not be responsible for payment of services and or supplies which were not requested Accordance with the contract. 7.4 AVAHCS will NOT pay for tests that are not clearly identified by product number on the invoice. 7.5 Invoices are to be separate for Amarillo and Lubbock laboratories but the usage of the same PO number is acceptable for billing purposes. 7.6 invoices will be electronically submitted to the Tungsten website at: 7.6.1 http://ww.tungsten-network.com/uk/en/ 7.6.2 Tungsten direct vendor support number is 877-489-6135 for VA contracts. 7.7 All invoices submitted through Tungsten to VA-FSC should mirror your current submission of Invoice. 8. SERVICE /MAINTENANCE REQUIREMENTS 8.1 A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour. 8.2 Equipment repair service shall be provided 24/7 for AVAHCS Laboratory and 5 days/week between 8am 5pm for Lubbock CBOC laboratory. 8.3 HOURS OF OPERATION 8.3.1 Normal hours of operations at the VAMC are Monday through Friday from 8:00 am to 4:30 pm, excluding holidays. 8.3.2 All work will be performed during normal hours of coverage unless requested or approved by Chemistry Supervisor or his designee. 8.3.3 Federal Holidays observed by the VAMC are: New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day 8.4 Equipment repair response time shall be no more than 24 hours. 8.5 Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 8.6 A malfunction incident report shall be furnished upon completion of each repair call. The report shall include, at minimum, the following: date and time notified, date and time of arrival, serial number, type and model number of equipment, time spent for repair, and proof of repair to include documentation of a sample run of quality control verifying acceptable performance. 8.7 Each notification for an emergency repair service call shall be treated as a separate and new service call. 8.8 Support shall include remote management software including diagnostics for equipment. Remote access to equipment is for diagnostic use only. 8.9 Contractor shall not access patient information. 9. SUPPPORT FEATRUES 9.1 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for acceptable operation. 9.2 The Contractor shall perform/assist with all validation studies listed below at no cost to the Government. 9.2.1 Correlation studies for each analyte 9.2.2 Linearity or Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. 9.2.3 Precision study using normal and abnormal control material. Intra-VISN facility variations should be kept at an absolute minimum. 9.2.4 Sensitivity/Specificity: efficiency, sensitivity, false positive rate and false negative rate 9.2.5 Carryover Studies. 9.2.6 Reference Range- Reference range assessment must be performed for each lab. 9.2.7 Accuracy/Recovery 9.2.8 Calibration Verification 9.3 Method performance/comparison shall be consistent with current CLSI guidelines, College of American Pathologists (CAP) standards and Federal regulations. 9.4 All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids as applicable. 10. OTHER 10.1 Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the order. A high incidence of such 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 satisfactorily to the user. 10.2 The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. 10.3 Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. 10.4 The vendor shall reimburse the facility for EXACT costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other vendor related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. 10.5 In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. 10.6 If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed. 10.7 This order should assist the Department of Veterans Affairs to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. 10.8 There following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals: Benzene Carbon tetrachloride Chloroform Dichloromethane Methyl ethyl ketone Toluene Methyl isobutyl ketone Xylenes Tetrachloro-ethylene Cadmium 1,1,1-Trichloro-ethane Chromium Trichloro-ethylene Cyanide Lead Mercury Nickel 11. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. 12. CONTRACTOR SECURITY REQUIREMENTS 12.1 This contractor requires no access to AVAHCS or any VA information system. The vendors analyzers will be compatible and interfaced to the AVAHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance. 12.2 NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. 12.3 The C&A requirements do not apply. A Security Accreditation Package is not required. 13. RECORDS MANAGEMENT 13.1 All records (administrative and program specific) created during the period of the contract belong to CTVHCS and must be returned to CTBHCS at the end of the contract. Attachment A AMA Estimated Annual Workload AMA ASSAY NAME SAMPLE TYPE PREFERRED Est Annual tests 1 Acetaminophen Plasma 209 2 Alanine Aminotransferase (ALT) Plasma 38825 3 Albumin Plasma 40930 4 Alkaline Phosphatase (ALKP) Plasma 36635 5 Alpha-fetoprotein (AFP) Plasma 31 6 Ammonia Plasma 118 7 Amphetamine Urine 12621 8 Amylase Plasma, Urine 719 10 Aspartate Aminotransferase (AST) Plasma 37134 11 Barbiturates Urine 12384 12 Benzodiazepines Urine 12609 13 Beta HCG Plasma 412 14 Beta hydroxybutyrate Plasma 53 15 Bilirubin, Direct Plasma 5911 16 Bilirubin, Total Plasma 38854 17 B-type natriuretic peptide (BNP) ONLY EDTA Plasma 2655 18 Calcium Plasma 55083 19 Cannabinoid Urine 12631 20 Carbamazepine Serum 34 21 Carbon Dioxide (CO2) Plasma 55082 22 Carcinoembryonic Antigen (CEA) Plasma 228 23 Chloride Plasma 55083 24 Cholesterol Plasma 29959 25 Cocaine Urine 12625 26 Complement C3 Plasma 31 27 Complement C4 Plasma 30 28 Cortisol Serum 238 29 Creatine Kinase (CK) Plasma 3415 30 Creatine Kinase (CKMB) Plasma 2407 31 Creatinine Plasma 58437 32 C-Reactive Protein (CRP) Plasma 11820 35 Digoxin Serum 85 36 Ethanol Plasma 546 37 Ferritin Plasma 787 38 Folate Serum 3920 39 Follicle-Stimulating Hormone (FSH) Serum 367 40 Free T4 Plasma 1993 41 Gamma-glutamyl transferase (GGT) Plasma 7237 42 Gentamicin Plasma 2 43 Glycohemoglobin A1c EDTA WB 10618 44 Glucose Plasma 57429 45 Hepatitis A Virus Antibody IgM Serum 22 46 Hepatitis B Core Antibody Total Serum 294 47 Hepatitis B Surface Antibody Serum 539 48 Hepatitis B Surface Antigen Serum 1978 49 Hepatitis C Virus Antibody Serum 2039 50 High-density lipoprotein (HDL) Plasma 29959 51 HIV Antigen/Antibody EDTA Plasma 628 52 Intact/intraoperative PTH Serum 155 53 Iron Plasma 685 54 Lactate dehydrogenase (LDH) Plasma 574 55 Lactic Acid Sodium Citrate 1130 56 Lipase Plasma 770 57 Lithium Serum 104 58 Luteinizing Hormone (LH) Serum 307 59 Magnesium Plasma 35049 60 Methadone Urine 6363 61 Microalbumin Urine 3597 62 Opiate Urine 12625 63 Phencyclidine Urine 12620 64 Phenobarbital Plasma 6 65 Phenytoin Serum 56 66 P2PSA (phi) Serum 93 67 Phosphorus Plasma 31078 68 Potassium Plasma 55320 69 Prealbumin Plasma 1004 70 Prolactin Plasma 360 71 PSA, Total Serum 8782 72 PSA, Free Serum 199 73 Salicylate Plasma 207 74 Sodium Plasma 55268 75 Syphilis Serum 360 76 Testosterone Serum 550 77 Theophylline Plasma 9 78 Total Protein Plasma 39267 79 Transferrin Plasma 665 80 Triglyceride Plasma 29980 81 Hs-Troponin I Only Plasma 2972 82 Thyroid-Stimulating Hormone (TSH) Plasma 12147 83 Thyroxine, Free (F T4) Plasma 1994 84 Urea Plasma 55121 85 Uric Acid Plasma 817 86 Valproic Acid Serum 343 87 Vancomycin Serum 522 88 Vitamin B12 Plasma 5288 89 Vitamin D 25-OH Plasma 7468 90 Urine Calcium Urine 6 91 Urine Chloride Urine 107 92 Urine Creatinine Urine 4606 93 Urine Magnesium Urine 1 84 Urine Phosphorus Urine 7 95 Urine Potassium Urine 109 96 Urine Protein Urine 800 97 Urine Sodium Urine 137 98 Urine Urea Urine 14 99 Urine Uric Acid Urine 4  Total tests per year  1,045,292 Attachment B AMA Optional Testing AMA ASSAY NAME SAMPLE TYPE PREFERRED Est Annual tests 1 Beta 2 Microglobulin Serum 83 2 Buprenorphine Urine 28 3 C-peptide serum 18 4 Homocysteine Serum  5 H. pylori Serum 358 6 Measles Serum 173 7 Mumps Serum 182 8 Oxycodone Urine 32 9 Procalcitonin Serum 1443 10 QuantiFERON Serum 566 11 Rheumatoid Factor Serum 212 12 Rubella Serum 171 13 Varicella IgG Serum 191 14 Testosterone Free Serum 301 15 Testosterone bio available Serum 65 16 Tramadol Serum 72 Total   3895 Attachment C Lubbock Estimated Annual workload LUB ASSAY NAME SAMPLE TYPE PREFERRED  1 Acetaminophen Plasma 0 2 Alanine Aminotransferase (ALT) Plasma 12942 3 Albumin Plasma 13643 4 Alkaline Phosphatase (ALKP) Plasma 12212 5 Alpha-fetoprotein (AFP) Plasma 0 6 Ammonia Plasma 39 7 Amphetamine Urine 4207 8 Amylase Plasma, Urine 240 10 Aspartate Aminotransferase (AST) Plasma 12378 11 Barbiturates Urine 4128 12 Benzodiazepines Urine 4203 13 Beta HCG Plasma 137 14 Beta hydroxybutyrate Plasma 0 15 Bilirubin, Direct Plasma 1970 16 Bilirubin, Total Plasma 12951 17 B-type natriuretic peptide (BNP) ONLY EDTA Plasma 0 18 Calcium Plasma 18361 19 Cannabinoid Urine 4210 20 Carbamazepine Serum 0 21 Carbon Dioxide (CO2) Plasma 18361 22 Carcinoembryonic Antigen (CEA) Plasma 0 23 Chloride Plasma 18361 24 Cholesterol Plasma 9986 25 Cocaine Urine 4208 26 Complement C3 Plasma 0 27 Complement C4 Plasma 0 28 Cortisol Serum 79 29 Creatine Kinase (CK) Plasma 1138 30 Creatine Kinase (CKMB) Plasma 802 31 Creatinine Plasma 19479 32 C-Reactive Protein (CRP) Plasma 3940 33 Digoxin Serum 28 34 Ethanol Plasma 182 35 Ferritin Plasma 262 36 Folate Serum 1307 37 Follicle-Stimulating Hormone (FSH) Serum 0 38 Free T4 Plasma 664 39 Gamma-glutamyl transferase (GGT) Plasma 2412 40 Gentamicin Plasma 0 41 Glycohemoglobin A1c EDTA WB 3539 42 Glucose Plasma 19143 43 High-density lipoprotein (HDL) Plasma 9986 44 Intact PTH Serum 0 45 Iron Plasma 228 46 Lactate dehydrogenase (LDH) Plasma 191 47 Lactic Acid Sodium Citrate 0 48 Lipase Plasma 257 49 Lithium Serum 0 50 Luteinizing Hormone (LH) Serum 0 51 Magnesium Plasma 11683 52 Methadone Urine 2121 53 Microalbumin Urine 1199 54 Opiate Urine 4208 55 Phencyclidine Urine 4207 56 Phenobarbital Plasma 0 57 Phenytoin Serum 0 58 P2PSA (phi) Serum 0 59 Phosphorus Plasma 10359 60 Potassium Plasma 18440 61 Prealbumin Plasma 335 62 Prolactin Plasma 0 63 PSA, Total Serum 2927 64 PSA, Free Serum 0 65 Salicylate Plasma 0 66 Sodium Plasma 18423 67 Syphilis Serum 0 68 Testosterone Serum 183 69 Theophylline Plasma 0 70 Total Protein Plasma 13089 71 Transferrin Plasma 222 72 Triglyceride Plasma 9993 73 Hs-Troponin I Only Plasma 991 74 Thyroid-Stimulating Hormone (TSH) Plasma 4049 75 Thyroxine, Free (F T4) Plasma 665 76 Urea Plasma 18374 77 Uric Acid Plasma 272 78 Valproic Acid Serum 0 79 Vancomycin Serum 0 80 Vitamin B12 Plasma 1763 81 Vitamin D 25-OH Plasma 1067 82 Urine Calcium Urine 0 83 Urine Chloride Urine 36 84 Urine Creatinine Urine 1535 85 Urine Magnesium Urine 0 86 Urine Phosphorus Urine 0 87 Urine Potassium Urine 36 88 Urine Protein Urine 266 89 Urine Sodium Urine 45 90 Urine Urea Urine 0 91 Urine Uric Acid Urine 0  Total tests per year  342,404
