SAMDaily.us | SRCSGT | 65 | Chemistry CPRR

SAMDAILY.US - ISSUE OF AUGUST 12, 2021 SAM #7194
SOURCES SOUGHT

65 -- Chemistry CPRR

Notice Date: 8/10/2021 12:34:55 PM
Notice Type: Sources Sought
NAICS: 334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office: 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
ZIP Code: 76006
Solicitation Number: 36C25721Q1318
Response Due: 8/17/2021 2:00:00 PM
Archive Date: 10/16/2021
Point of Contact: robyn.nussbaum@va.gov, Robyn Nussbaum, Phone: 806-354-7830
E-Mail Address: robyn.nussbaum@va.gov
(robyn.nussbaum@va.gov)
Awardee: null
Description: 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...
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Place of Performance: Address: Department of Veterans Affairs P&LMS Section 6010 Amarillo Blvd W, Amarillo, TX 79106, USA; Zip Code: 79106; Country: USA
Record: SN06092536-F 20210812/210811201716 (samdaily.us)
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65 -- Chemistry CPRR