Q301--Amarillo VAHCS Diasorin Quantiferon TB Testing

Statement of Work Cost per Patient Reportable Results for Immunoassay for Infectious Disease Testing Amarillo VAHCS BACKGROUND The Amarillo Veterans Affairs Health Care System (AVAHCS) Department of Pathology & Laboratory Service requires a sole source, CPT procurement to conduct a variety of infectious disease tests for our patient population which includes Quantiferon TB testing. Our current immunoassay analyzer in-house is the Diasorin Liaison XL located at the Amarillo VA Health Care System in Amarillo, TX. The use of the current Liaison XL is through our Cost Per Reportable Result (CPRR) contract with Beckman Coulter (BCI) for the AU, Powerlink, and DXI800 system at the Amarillo location for Hepatitis testing only. Due to the confusing nature of ordering supplies for the Liaison from BCI as well as procuring a supply only contract from Diasorin for the MMRVW and Quantiferon TB testing, it seems to be in the best interest of the government to combine the infectious disease testing with the Diasorin supply contract and indicating the procurement as a sole source due to the Quantiferon TB test. BCI CPRR contract is due to expire 8-30-2024, and it is not guaranteed at this time, that the new automation and new Chemistry analyzer contract will be awarded to the current vendor; therefore, the possibility of losing the Diasorin Liaison XL analyzer currently in use through the BCI contract. The laboratory is including estimated annual volumes for all testing (Refer to Attachment A). At a minimum, the vendor must be able to supply equipment/analyzers that can process from primary sample tubes, has an automatic clot detection/removal mechanism, supplies/reagents/consumables; electronic inventory ordering system, technical telephone support, middleware that will provide standardized process for result handling/review, and must meet the following requirements as provided in the Scope. SCOPE The vendor shall provide/install: The most current immunoassay analyzer combined platforms which will include the ability to link multiple analyzers (i.e. robotics line). An Immunoassay contract for infectious disease testing menu for CPT model with Indefinite Delivery Indefinite Quantity (IDIQ) with a firm-fixed price task per test order for processing/ analyzing in-house immunoassays to replace, without incurring testing delays or additional costs for 60 months. One primary analyzer system for the Amarillo location with the possibility of adding a mirror analyzer or smaller to the Lubbock location at a later time should the testing workload allow with no additional charges. Tests shall be vendor supported and they will be located at: Amarillo Veterans Affairs Health Care System 6010 Amarillo Blvd., West Amarillo, TX 79106 Attention: P&LMS Optional: Should the option of adding a mirror analyzer to the Lubbock location or smaller, all tests shall be vendor supported and will be located at: Lubbock Community Based Outpatient Clinic (CBOC) 3510 4th Ave Lubbock, TX 79415 Attention: Laboratory The facility with Food and Drug Administration (FDA) approved equipment/analyzer , reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, middleware and any other item required for the proper operation of the contractor s equipment/analyzer necessary for the generation of the listed patient reportable result on both the primary and back-up equipment/analyzers. (This does not include those items approved for exclusion by the government such as printer paper, labels, etc.). Equipment/analyzers that have accurate capability of monitoring reagent usage (metering) and provide inventory upon request, in real time. This will require the vendor to: Provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment /analyzer such that equipment/analyzer operations are not interrupted. The items in 6.a. shall be of the highest quality, sensitivity, and specificity, and tested to assure precision and accuracy. Expiration date must be clearly marked on all reagents, standards, calibrators, and control containers. Unexpected changes in methodology/technology shall be at the expense of the vendor. All Alerts/Notifications of any delays in shipment as well as any or all technical advisory/recalls/alerts shall be posted prior to or simultaneously post with field alerts. Any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, drainage systems, water systems, UPS, and surge protectors/suppressors. Also to include, any engineering controls necessary to maintain proper operating temperature(s). If required, a Deionized (DI) water system and maintenance, as designated by the manufacturer of the system, to include consumable polishers, filters, preventative maintenance, labor repair, and repair parts. Set-up a flexible monthly supply delivery schedule and/or on as needed basis . In the event that supplies/reagents/consumables are found to be defective and unsuitable for use with the vendors equipment/analyzer, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor is required to deliver replacement supplies/reagents/consumables with 24hours of receipt of a verbal order for emergency delivery at no additional cost to the Government. EQUIPMENT FUNCTIONALITY All equipment/analyzers must have primary tube sampling capability and be able to sample directly from aliquot containers of various sizes. The equipment/analyzers must have a comprehensive Quality Control (QC) Program for all tests which includes at a minimum the following options: QC files may be edited or corrected for errors manually with/without password protection. On-board QC data storage and reporting capabilities. The ability to view/print daily and monthly QC results. The ability to view/print Levey Jennings graphs. On-line documentation of out of range QC. Westgard rules or other QC acceptance criteria built in. Equipment/analyzers shall have automatic on-board dilution capability when defined limits are exceeded with minimal off-line dilutions required without operator intervention. Vendor will include with the proposal the tests the equipment/analyzer will dilute automatically. Equipment/analyzer shall have user defined reflex and repeat testing capabilities. Equipment/analyzer shall accept serum, plasma, urine, cerebrospinal fluid, and other body fluids as required per the standard operating policy of each individual test method that is contracted. Equipment/analyzer shall have a design that removes the possibility of reagent and sample carryover. Vendor shall perform carry over studies as part of the initial evaluation of the equipment/analyzer. Vendor shall provide interpretation of raw data for each equipment/analyzer installed. Vendor shall also provide documented evidence confirming the equipment/analyzer removes the possibility of any reagent and sample carryover. Equipment/analyzer shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. Equipment/analyzer shall have the ability to perform specimen indices (hemolysis, icterus, and lipemia) for all/designated specimens. Vendor shall list the reagents, calibrators, and controls that require any additional preparation prior to use such as warming/mixing/reconstitution. Minimal reagent preparation. STAT interrupt capability. Demonstrated Integrated Clinical Chemistry/Immunochemistry Instrumentation platform that can be able to link multiple analyzers ((i.e. robotics line) if compatible. On-board electronic troubleshooting guide. Ease of calibration with extended calibration stability and reduced calibration frequency. Able to perform tests to specifications as defined by 1988 Clinical Laboratory Improvement Acts (CLIA) and Clinical Laboratory Standards Institute (CLSI) standards including satisfactory College of American pathologist (CAP) peer group comparisons. Equipment/analyzer must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. Equipment/analyzer shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime. Interfacing requirements to be provided by the vendor: Equipment/analyzers Laboratory Information System (LIS ) physical connection and translation (drivers) must be compatible with Data Innovations system. Any additional hardware and software needed to interface the equipment/analyzer and technical assistance with interfacing the equipment/analyzer. Equipment/analyzer LIS interface shall be bi-directional. If the host system software requires the use of non-proprietary universal interfacing system to provide bi-directional interfacing capabilities with Data Innovations System to achieve connection, the awarded vendor shall bear the cost of the interface including hardware and software. A bi-directional bar-coded computer interface with the ability to read standard barcode format such as Code 128 and Code 39. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA VistA hospital information system (Refer to 18.e Brief Summary of VistA Functionality ) at the time of award. Brief Summary of VistA Functionality VistA is very limited in its functionality to manage laboratory quality control, provide Levey-Jennings plots/graphs or administer an interment maintenance program. VistA is a public domain system to the VA whose functionality includes: Management of patient information through a database. Acceptance of test ordering information. Transmittal of patient laboratory test results. Storage and retrieval of patient laboratory test results. Computer Interface Requirements The vendor 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 item an instrument is added to an existing universal interface system. If a site already has a universal interface system, the vendor 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. If a site does not have a universal interface system and one is needed to optimally interface the equipment/analyzer, the vendor is responsible for the acquisition of the universal interface box and everything required to connect with the VA computerized hospital information system. If there are any software upgrades to the instrument during its life, the vendor shall be responsible for insuring the equipment/analyzer continues to interface appropriately with VA hospital information system. INSTALLATION AND VAILDATION Vendor shall move equipment/analyzers, free of charge, to final testing location upon completion of validation process. Due to the remodel of the AVAHCS, vendor shall relocate the analyzer and complete validation process upon moving back into the newly remodeled lab. Vendor shall provide, at no cost to the Government, at installation/set-up and when bringing new tests online, a technical support specialist who shall perform all validations studies including: Start-Up Reagents The vendor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish equipment/analyzers for operation, for performance of acceptance testing. This applies to all equipment/analyzers as well as additional or replacement equipment/analyzers placed under the terms and conditions of the contract. Installation/set-up Correlation Studies (evaluation/comparison data sufficient to satisfy CAP standards) Normal Range (reference range) studies must be performed using samples representative of the patient population being tested. Precision studies shall be performed using normal and abnormal control material. Intra-VISN facility variations should be kept to an absolute minimum. Method comparison with current equipment/analyzers shall be at the expense of the vendor and shall be consistent with current CLSI guidelines and related documents; CAP standards, and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine, and all body fluids as applicable. Accuracy (recovery) studies. Analytical Measurement Range (AMR)(linearity) studies shall be performed on proposed equipment/analyzer for each anlayte to validate the reportable range Calibration verification studies. Verification of reference intervals. Sensitivity studies Specificity studies shall include a review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Carryover studies for reagents and samples shall be successfully completed by the vendor on all equipment/analyzers during installation/set-up. These studies shall be performed using either vendor developed programs or programs developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge to the Government. Staff Training In-services to laboratory personnel and clinicians, Assist with any methodology problems and questions. This service shall be available 24hours per day, 7 days a week, and 365 days a year including holidays. The vendor shall perform all of the statistical analysis as stated in the Installation/Set-up section (2.b. i-ix) and provide a hard-copy of data in an organized, clearly comprehensible format. Test counts for billing at each location shall begin after review and approval by the AVAHCS Chemistry Technical Specialist, Laboratory Manager, and Chief, Pathology and Laboratory Medicine Service, of all correlation and linearity studies at the specified facility. (Refer to section SCOPE 3 and 4) Installation, startup assistance, and all validation studies of the three (3) equipment/analyzers shall be completed no later than 90 days after date of award. The performance period shall commence on the date of installation. Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintaining/troubleshooting user-defined assays as additional test/assays are brought in-house. WATER SYSTEM (if required) Vendor shall install water systems, if water is required for the three (3) analyzers at each location. (Refer to section SCOPE 3 and 4 for location) Maintenance/service for the water system is included in the CPRR. Maintenance/service labor and cost of parts and replacement parts is the sole responsibility of the vendor. TRAINING The vendor shall provide initial Primary User Training for a minimum of one user per equipment/analyzer installed with on-site training available to remaining users on all tours with competency assessments performed and documented. Primary user training shall be arranged by the vendor and shall include all costs of off-site training. Vendor shall provide one (1) additional off-site training slot per instrument for each completed year of customer agreement included upon request. Vendor shall provide off-site training for two (2) key operators for the Amarillo location for Data Management Training (DMT). The DMT shall be arranged by the vendor and shall include all costs of off-site training. Optional: If required due to the addition of a mirror analyzer and/or smaller analyzer at the Lubbock location, one (1) key operator for the Lubbock location for Data Management Training (DMT). The DMT shall be arranged by the vendor and shall include all costs of off-site training. Vendor shall provide on-site training to the remaining users (Amarillo and Lubbock if needed) on all tours with competency assessments performed and documented. Vendor shall provide all necessary procedure manuals, troubleshooting manuals, and operator manuals (also available on computer disk format). Procedures shall be in the CLSI format. SERVICE AND MAINTENANCE Vendor shall provide assistance with support services, troubleshooting, and repair of the equipment/analyzer. On-site service shall be available Monday through Friday during regular business hours (8am-5pm). If testing is unavailable due to analyzer downtime/malfunction, the vendor shall provide on-site service 24 hours/day; 7 days a week; 365 days/year including holidays. Certain circumstances may dictate the need for service to be conducted outside the routine business hours. All such arrangements shall be coordinated between the vendor and the VA laboratory personnel. Equipment/analyzer repair shall be no more than 24 hours. The support service shall follow up all downtime calls with one (1) hour of receiving the initial complaint. A down time (malfunction) incident report shall be furnished to the laboratory upon the completion of each service/repair call. The report shall include: Date and time notified Date and time of arrival Serial number, type and model number of the equipment/analyzer Time spent for repair and proof of repair that includes documentation of a sample run of QC verifying acceptable performance. The vendor shall provide a 24/7 service hotline with technical support. The vendor shall provide timely visits for preventative maintenance performed by the vendor as required. The vendor shall supply engineering controls if necessary for any heat, humidity, or noises issues that may results from the use of the proposed equipment/analyzer. The vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge (e.g. upgrades that correct or improve either the mechanical operation, or software of the system that would keep the equipment/analyzer performing optimally). The vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance tasks. Vendor shall indicate which tasks are user level and which are service representative level. Remote monitoring shall not be a substitute for on-site maintenance/repair service. However, the vendor may include remote monitored maintenance/troubleshooting software program that electronically transmits critical operational and administrative information from the equipment/analyzers to our internal systems via a secure Internet connection as a part of their offer. This secure, encrypted technology shall enable transfer of key logs, report generation, and remote service developments. It should also offer the potential to improve inventory management by enhances troubleshooting information made available to a technical support group, a portal to access instrument logs, files, maintenance information, software version, proactive instrument operations monitoring, predictive instrument maintenance, and QC data collection for peer review. The vendor shall provide a mechanism for the laboratory to meet local discharge requirements for reagents with hazardous constituents. The vendor shall supply information regarding any hazardous chemicals. BILLING Vendor shall bill monthly in arrears. Test counts for billing at each location shall begin after review and approval by the AVAHCS Special Chemistry Technical Specialist, Laboratory Manager, and Chief, Pathology and Laboratory Medicine Service, of all correlation and linearity studies at the specified facility. (Refer to section SCOPE 3 and 4). This will be known as the Go-Live date. Each analyzer shall be metered independently of each other, but the billed invoice is to have all three analyzers on one invoice as if to be billed independently. It is understood that all payments shall be the responsibility of the Amarillo location. Payment will be made upon receipt of a properly prepared detailed invoice prepared by the Contractor, validated by the COR, and submitted to VA Government Electronic Portal, www.tungsten-network.com Invoice: A properly prepared invoice shall contain: Invoice Number and Date Contractor s Name and Address Contractor s Point of Contact name, phone number, and email address Accurate Purchase Order Number for the Period of Performance (POP) Supply/Consumables/ Controls/Calibrators and/ or Service provided Quantity requested/received/ordered Correct Period of Performance (POP)of the requested/order of supplies Consumables/ Controls/Calibrators and/ or Service provided MUST be documented on the invoice. Total Amount Due OTHER Assessment of testing needs/menus shall be evaluated as needed by the laboratory with communication to the vendor to receive pricing. There shall be easy assimilation for new tests in to the pricing test lists without the need for line items additions to the agreement. Request for instrument 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 contract. 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 equipment/analyzer(s) that can produce the required criteria satisfactorily to the user. The vendor shall remove all equipment within 90 days after notification of the expiration of terms of this agreement but not until the completion of new vendor s equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any equipment/analyzer. The vendor shall reimburse the facility or facilities for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility or facilities due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. The vendor shall provide, install, and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. Uninterruptable Power Supplies with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc), and universal interface equipment. In addition, the contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, table/stands, etc. In the event that any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor s equipment/analyzer, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery to the facility or facilities. If either circumstance has occurred, the vendor shall deliver to the facility or facilities, in the most expeditious manner possible, without additional cost to the facility or facilities, the necessary consumables in sufficient quaintly so testing is not delayed. Characterization of waste: The contractor shall provide documentation that 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 shall 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 Regulation Title 40 to make a determination if the waste is hazardous waste or otherwise regulated. The determination and description shall 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 vendor shall provide written instructions and training material to ensure the 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 must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Vendor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW) and State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosiveness, reactivity, and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall 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, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor 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 This contract should assist AVAHCS P&LMS and the Lubbock CBOC laboratory to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. SPECIAL REQUIREMENTS: The following P&LM personnel are authorized to place orders as needed via telephone: a. Amarillo, TX. i. Erin Howard Erin contact@example.gov +1 (555) 000-0000 ext. 7504 ii. Wilson Le contact@example.gov +1 (555) 000-0000 ext. 7074 iii. Yvette Goodson contact@example.gov +1 (555) 000-0000 ext. 3550 Any changes referencing authorized staff as stated above will be communicated to the contracting specialist/officer and the contractor in writing throughout the life of the contract as an internal ordering guideline submitted by the COR. All used equipment and consumables should be treated as infectious material and the use of universal precautions is required by the operators the vendor field service operators. LICENSING/ACCREDITATION SECURITY /CONFIDENTIALITY The Vendor shall have all licenses, permits, accreditation and certificates required by law and or regulatory compliance. Personnel assigned by the Vendor to perform these services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. "The C&A requirements do not apply, and that a Security, Accreditation Package is not required. Attachment 1 Part # Description Est Workload usage / yr 1 318910 Liaison H. Pylori IgG 100 2 318981 Liaison H. Pylori IgG control set 6 3 318810 Liaison Measles IgG 200 4 318811 Liaison Control Measles IgG 6 5 318840 Liaison Mumps IgG 200 6 318841 Liaison Control Mumps IgG 6 7 310495 Liaison VZV IgG 200 8 310496 Liaison Control VZV IgG 6 9 310460 Liaison Rubella IgG 100 10 310561 Liaison Control Rubella IgG 12 11 310210 HAV IgM 24 12 310211 HAV QC 6 13 318240 HCV AB 1507 14 318241 HCV QC 6 15 318220 HBsAB 1994 16 318223 HBSaB VERIFY 4 17 318130 HBCore total 1966 18 318131 HBCore QC 6 19 318250 HBsAg 2322 20 318251 HBsAg QC 6 21 318290 HIV 746 22 318291 HIV QC 6 23 310840 TREP 352 24 310842 TREP QC 6 25 311020 QUANT TB 565 26 310995? Liaison XL Cleaning Kit - - - - - 2 27 319100 Liaison Wash / System Liquid - - - - 8 cases 28 319100 Liaison XL Starter Kit 18 boxes 29 319200 Pipette Tips 20 boxes 30 X0005 Liqui NOX 2 bottles 31 X0016 Cuvettes 20 boxes 32 Unknown Bio Bags 1 box 33 Qiagen 623536 QFT-PLUS HA Tubes (50 X TB1 / TB2/ NIL/ MIT) 20 boxes