Page 5 of 5 THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), 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 RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is an RFI ONLY. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 334516 (size standard of $30.0 Million). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide a Chemistry / Immunoassay platform CPT IDIQ that at a minimum meets the following Statement of Work for the Veterans Integrated Service Network 22: STATEMENT OF WORK/SPECIFICATIONS STATEMENT OF WORK Introduction and Scope of Required Specifications The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work for all Chemistry, Immunochemistry and infectious disease related testing. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory as defined by volumes in Attachment A Tab 2. The Contractor is required to provide a continuously stocked inventory of reagents, standards, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Equipment: All equipment shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for each of the stations located at the following VISN 22 facilities: See section 1.6 Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Chemistry/Immunochemistry equipment, supplies and related services. Definitions Cost per Test (CPT) Individual billing cost on a per test basis inclusive of all reagents, consumables, instrumentation, standard shipping, labor/services and installation as defined throughout section 1.7. CPT pricing is billed per test as per Attachment A and Section 1.7. Business Associate Agreement (BAA) A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Primary Processing Automation Line Pre-analytical processing equipment offered to each of the VA laboratories listed in section 1.6 that will automate the pre-analytical specimen processing functions, as indicated in the general requirements section. Specimen Management System A component of the Processing Automation Line that directs and manages the operation and components of the pre-analytical processing/automation system. Contractor 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 Dawning). Throughput The speed that the equipment processes and/or operates reported in units per hour. TEST MENU: Test 5 yr Volume Test 5 yr Volume Test 5 yr Volume Alpha 1 Antitrypsan 22,982 Ethanol, Urine and Blood 346,656 Oxycodone 741,148 Acetaminophen 56,944 Ferritin 349,633 PARATHYROID HORMONE (Intact) 141,466 ALBUMIN, Blood 3,889,577 FOLIC ACID (Folate) 354,851 Phencyclidine 243,849 ALBUMIN, Urine 236,970 Free T4 696,066 Phenobarbital 15,308 Alkaline Phosphatase 3,792,986 Follicle-Stimulating Hormone (FSH) 61,203 PHENYTOIN, (Dilantin) 30,911 ALPHA-FETO PROTEIN (AFP) 87,320 Gamma-Glutamyl Transferase (GGT) 335,652 PHOSPHORUS, Urine, Blood 1,462,104 Alanine Aminotransferase (ALT) (SGPT 3,889,326 Gentamicin 14,466 POTASSIUM, Urine, Blood 5,575,763 Amikacin 8,457 GLUCOSE, Urine, Blood, Fluid, CSF 5,414,752 Prealbumin 55,417 Ammonia 52,970 Haptoglobin 35,343 Prolactin 57,296 Amphetamines 985,694 HDL Cholesterol 2,486,357 Prostate Specific Antigen (PSA) 1,122,216 Amylase, Blood and Urine 154,583 Hepatitis A IgM 42,768 PSA, Free 17,803 Aspartate Aminotransferase (AST) (SGOT) 3,694,662 Hepatitis A IgG 11,171 Protein, TOTOAL Blood, Urine and Fluid 2,661,879 Barbiturates 603,204 Hepatitis A Total 81,350 Rheumatoid Factor 62,647 Benzodiazepines 984,952 Hepatitis B Core AB Total 146,818 Salicylate 68,099 Benzoylecgonine 488,318 Hepatitis B Core IgM 48,950 SODIUM, Urine and Blood 5,658,055 Beta-Hydroxybutyrate 25,911 Hepatitis B Surface Ab 188,248 TESTOSTERONE, Total 217,325 Beta 2 Microglobulin 16,350 Hepatitis B Surface Ag 188,009 Testosterone, Free 51,191 Bicarbonate (CO2) 4,917,945 Hepatitis C Ab 399,330 Theophylline 20,230 Bilirubin, Direct 767,677 Hiv- 1/2 Antibody with antigen ("4th generation" HIV testing) 247,138 Thyroid-Stimulating Hormone (TSH) 1,889,217 Bilirubin, Total 3,824,784 Homocysteine 41,592 Tobramycin 4,125 Blood Urea Nitrogen (BUN) 4,816,398 Human Chorionic Gonadotropin, Beta, Quant (HCG. Beta) 51,465 Total T-3 41,062 B-type Natriuretic Peptide (BNP) 260,891 IgA 74,917 TRANSFERRIN 344,655 Buprenorphone 531,476 IgE 33,096 Triglycerides 2,485,321 CALCIUM, Urine and Blood 4,047,901 IgG 67,135 Troponin 574,813 Cannabinoids 863,878 IgM 65,485 UREA NITROGEN, Urine and Blood 3,632,014 CARBAMEZAPINE 26,920 IRON 368,586 URIC ACID, Urine and Blood 293,095 Carcinoembryonic Antigen (CEA) 46,916 Kappa light chain, free 49,157 Valproic Acid 69,677 CHLORIDE, URINE, BLOOD and, CSF 4,972,068 LACTIC ACID, BLOOD and CSF 255,902 Vancomycin 89,383 Cholesterol, Total, Blood and Fluid 2,807,443 Lactate Dehydrogenase, Blood, Fluid, CSF (LDH) 236,982 Vit-D-25 Hydroxy Total 1,237,939 CK-MB 69,905 Lambda light chain, free 53,104 Vitamin B-12 618,919 Complement Component 3 (C3) 38,192 LDL Cholesterol, Direct 474,320 Cyclosporine 8,579 Complement Component 4(C4) 38,877 Lipase 253,349 Free T3 20,910 Cortisol 55,724 Lithium 58,556 Hemoglobin A1c 2,220,527 C-REACTIVE PROETIN 51,392 Lutenizing Hormone (LH) 61,092 NT-pro-B-type Natriuretic Peptide (NT-proBNP) 73,378 C-REACTIVE PROTEIN, High Sensitive 274,203 Magnesium, Blood and Urine 1,506,734 Procalcitonin 71,907 Creatine Kinase (CK) 329,609 Methadone 625,029 Quantiferon TB 128,979 CREATININE, Urine and Blood 7,380,716 Microalbumin 829,845 Sirolimus 7,007 DIGOXIN 52,295 Microprotein/M-TP (CSF) 13,870 Tacrolimus (EK506) 39,697 Estradiol 36,859 Opiates 986,073 Total T-4 10,742 Instrumentation Requirements Analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all technical specifications of this contract. Contractor shall provide an Integrated Clinical Laboratory Chemistry/ Immunochemistry Instrumentation and Robotics System (Automated track or line). Equipment shall have sufficient capacity and throughput to meet the volume and service demands as defined in the table above during peak workload analysis. The solution should allow for 3% growth in volume per year for the term of the contract with options. The capability of performing analysis on 100% of the required tests listed in above. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. System shall include a patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation. All monitors/screens will clearly display information in all light conditions. Ability to prioritize STAT testing without compromising existing programmed testing. Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run. The ability to continuously load patient specimens. The ability to detect specimen clots with alert notification. The capability to auto dilute a test when defined limits are exceeded. The capability of incorporating third party reagents through the use of open channels on chemistry analyzers. Calibration and Reagent Management System must have on board reagent stability sufficient to accommodate volumes above. The ability to detect and alert operator of low reagent and consumable levels. The ability to calibrate more than one lot of a reagent at a time. The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations. The capability to calibrate assays during test run without aborting the run. The capability to store, print, and retrieve calibration data from the instrument. Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor. Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration Single lot of reagent for each test/analyte per monthly shipment with a minimum reagent expiration date of 120 days unless otherwise specified and approved by COR prior to shipping. Ability to reduce out-of stock issues and on-hand inventory. System shall maximize on-shelf availability and expiration date management. Specimen Management System / Automated Track The system shall be capable of or possess the following: A line or track system will be provided to connect all testing analyzers with the capability of incorporating new technologies via automated line expansion. Specimen management system to manage and track sample progress and position to maximize efficiency and turnaround times. The system shall also be able to sort specimens based on test requests (Line/track system/ Specimen Management System) Specimen archival through mapping of specimens to racks for room temperature samples or to a refrigerated stock yard for easy retrieval once moved off-line. Send processed specimens by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. (Line/track system/ Specimen Management System) The ability to prioritize STAT specimens when introduced to automation. Minimize operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen. (i.e. Stat specimen lane for introduction of sample/ Specimen Management System) The ability to detect processing errors and provide error notification. (Specimen Management System) The ability to isolate connected analyzers from the automation and processing equipment when necessary (Specimen Management System). The ability to process both spun and unspun specimens simultaneously (Inlet or similar device). The instrumentation shall be capable of handling 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. The ability to separate the serum/plasma from the blood cells through the process of centrifugation. For high volume labs, a second centrifuge or as many as appropriate shall be integrated into the line. Capper/Decapper/Aliquoter The ability to remove the collection caps from a variety of types and sizes of blood collection tubes. (Decapper) The ability to cap and/or seal a variety of types and sizes of blood collection tubes. (Recapper) When available option to add the ability to remove a segment of serum or plasma from the primary tube to another specimen tube (Aliquoter module). An aliquoter module should be a modular addition that can be removed from final designs if needed. The aliquot tube should be standard size (i.e. 13 mm diameter and 75 mm length). Aliquot tubes must meet Department of Transportation (DOT) and International Air Transport Association (IATA) regulations for shipping. Refrigerated Stock Yard (Move to Automation Potentially) Refrigerated stock yard will have storage for 7 days worth of samples as defined by the volumes to be determined. The refrigerated stock yard will maintain and store specimens from 2-8 degrees centigrade. (Refrigerated Storage) Barcoding Barcoding stations located at key points along the line or track system must have the following capabilities The accuracy of the barcode reading must have less than a 1.0 % failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric and may be concurrently. Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology. Track reagent inventory by bar code or radio-frequency identification (RFID). Testing Capability IDMS traceable Creatinine reagent. Less than 5% of test menu will require sample pre-treatment. Required Analytes- The combined instrumentation and automation track must be capable of analyzing the analytes identified above in section 1.2.7; if not available directly, then available via the manufacturer and the contractor will assist with set up and validation for third party assays. Printers and Other Support Items (Support Items) A printer(s) that has the capability of printing a patient report with patient demographic information that includes the patient s name, medical record number (SSN) and accession or unique identifier number (UID). The contractor must repair or replace the printer if malfunctioning within 24 hours for the duration of the contract. 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 after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. Software, Connectivity and Conformance Standards Instrument Software Internal to testing instrumentation that provides/maintains the following: Ability to monitor instrument performance. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records. 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. Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 72 hours in case of interface outage. Capability to record, store and print the following information: Required quality control, calibration, and instrument maintenance information. Patient demographic information and specimen results. The capability to program a test as a repeat with interfacing of results to overlay initial result. Ability to retransmit patient records to universal interface system (including middleware) in case of interface outage. Customization Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing) Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology). Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity. At a minimum consultation should include auto-verification workflows and/or an auto-verification rules library to be used during setup. The contractor shall provide education to key personnel on how to maintain functionality of these operations. At minimum this education should include middleware training for standard operations and rules writing. Interface A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software as needed) shall be immediately available for implementation to the VA computerized hospital information system. The Contractor shall provide all system configuration options and diagrams for any hardware and/or software with annotation of whether contractor provided, or VA provided required for the connection, implementation, and operation of the interface to the VA licensed Data Innovations Instrument Manager. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. The contractor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements. Any wireless equipment must be FIPS 140-2 compliant as well, and contractor must provide the FIPS 140-2 certification for any wireless equipment upon request. If there are software upgrades in the instrument during its life, the Contractor is responsible for ensuring that the interface can accommodate any changes in the data stream going to the VA Laboratory Interface Middleware. Technology must interface to VA licensed Data Innovations Instrument Manager sending all appropriate information in order to complete auto verification rules processing within the VA licensed IM. Preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA licensed DI IM. Connectivity and Conformance Contractor must have existing VA MOU/ISA prior to award which must include remote monitoring and support. Contractor should use remote monitoring to prevent instrument or testing issues as possible in addition to troubleshooting and support. The Contractor shall include a copy of the MOU/ISA as part of their quote with the file named VA MOU/ISA . The Contractor shall provide all hardware and software in order to implement the remote support system. The Contractor supplies responses to required documents in order to add systems to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication Protocol, MSD2, and the Risk Analysis Tool. The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network (Windows 10 and Server 2012/2016). Must be capable of connecting to an HL7 interface and must comply with the VHA Lab HL7 Interface Specifications Document. https://www.va.gov/vdl/application.asp?appid=71 https://www.va.gov/vdl/application.asp?appid=75 The contractor s performance must be in compliance with all applicable state, federal and local laws and regulations. Any software solutions supplied and installed on VA workstations by the contractor must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must be within 2 lifecycles of the most recent TRM approved version. Or the contractor must have the capability obtain a TRM approval without impacting installation timeframes in section 4. https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx. Contractor must have a Memorandum of Understand/Information Security Agreement (MOU/ISA) with the VA or the capability to obtain an MOU/ISA without impacting installation timeframes in section 4. https://vaww.portal2.va.gov/sites/infosecurity/FY15CRISPAudit/CRISPRemediationContract/WorkSite/SitePages/MOU-ISA_Version2.aspx Support Features Service Maintenance / Warranty The Contractor shall be able to provide equipment repair and preventative maintenance on all primary instrumentation and ancillary equipment within the provided system. The contractor provides 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 All equipment, including ancillary equipment, repair service shall be provided Monday through Friday from 07:00AM to 07:00PM. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. If one analyzer is down service converts to 24/7 to maintain all operations. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than 4 hours. Delivery of parts and equipment to fix instrumentation must be within 24 hours to prevent excessive downtime at the cost of the contractor. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date or more frequently based on instruments performance. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a 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 that includes documentation of a sample run of quality control verifying acceptable performance. Cause (i.e. user error, part failure, etc ) Each notification for an emergency repair service call shall be treated as a separate and new service call. The Contractor shall provide, install, maintain, and repair through the life of the IDIQ, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. UPSs with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, deionizers, filters, preventative maintenance and repair, etc.), and universal interface equipment, etc. 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, tables/stands, etc. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. Government s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. This section establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or IDIQ] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the go live date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in the IDIQ at an effectiveness level of 90% or more. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement at no charge or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the IDIQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination may be made by the COR and contracting officer to replace the malfunctioning equipment with new equipment at no additional charge. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the contract. The same terms and conditions apply to ancillary/support equipment provided under this IDIQ, i.e., water system, printers, UPS, etc. The Contractor shall provide a warranty for all items and services provided under the IDIQ for the duration of the IDIQ and all associated delivery orders Reports All reports must be approved by the medical director. Additional studies will be at the expense of the contractor until results meet the criteria defined by the medical director. The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. At the end of each IDIQ year (base and each option), an annual report of sales by participating facility as well as a VISN total will be provided. In addition, a total IDIQ sales/savings report will be provided at the expiration of the IDIQ, to include any extensions. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the IDIQ. These reports will be in an Excel spreadsheet, multiply tabs may be used, to include a VISN summary tab. Training The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services. The CPT shall include key operator training for minimally 2 operators per each instrument installed. Training shall be provided on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally two operators per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. In addition, operator training shall be provided by Contractor on-site for all operators on all shifts (day shift: 7:00 p.m. 3:30 p.m., evening shift: 3:00 p.m. 11:30 p.m. and midnight: 11:00 p.m. 7:30 a.m.), as applicable. Additional onsite training will be provided 60-90 days after instrumentation s go live date. Contractor shall at minimum provide on-site training for up to 8 hours per site as requested by the facility. Contractor will provide example policies and procedures such as standard operating procedure templates. Waste The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation 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 Regulations Title 40 to make a determination if the waste is a 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 contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Contractor 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), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, 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, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system Upgrade/Updates: The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system updates that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability. Should the VISN decide to upgrade their current equipment ie. - replacement of existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement. SECTION D PACKAGING & MARKING Packaging All equipment and supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor s expense. Marking All items shall be marked clearly with the IDIQ Number, Delivery Order Number, Obligation number and delivery location within the hospital i.e. Emergency Room. For major Equipment, the Obligation number shall begin with an A after the station number i.e. 600A20000. All other service items shall be marked with a C number i.e. 600C20001. The Delivery Order number shall have a format similar to this example: 36C26221N0001. SECTION E/F INSPECTION AND ACCEPTANCE / DELIVERIES & PERFORMANCE Installation/Implementation Implementation/transition timeframe: All sites shall have complete installation and go live of their system within one year of award of this IDIQ. Contractor shall execute an implementation plan which includes: Installation - Contractor shall make every effort to conduct a concurrent implementation at all sites with weekly collaborative meeting. Contractor shall provide a dedicated project manager throughout the entire implementation. Installation shall also include conversion of all current data minimally including operator profiles. Testing- Shall include at minimum a test of all analytes in addition through all testing phases (pre- analytical, analytical, and post-analytical). In addition, training must be provided to all sites. Acceptance-Must meet the approval requirements of accrediting agencies and laboratory medical director approval at each facility to meet accreditation standards. Go-Live- Dedicated project management and technical support must be available above the requirements of Section 3.4.1 the day of go-live at each site for 3 days. Post Go-Live Follow Up- Check-in should include at least a two week and 30 day after go-live date. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. This applies to equipment as well as additional or replacement equipment placed under the terms and conditions of this IDIQ. The Contractor shall perform/, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all statistical analysis as stated in the Method Performance/Validation section below and provide a hard copy of data in an organized, clearly comprehensible format. Onsite Go live Instrument and Automation Support Requirements shall consist of 48 hours of continuous support. Daily onsite support for a total of five business days for each phase of implementation. Must support successful implementation and a non-manual method of uploading historical data, i.e. operators and meters/analyzers in the transition from different system. Post Implementation 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. This shall include sending personnel to the site to optimize the analyzer, automation and data management work flows six months and twelve months after the system has gone live. Optimization must include supplier to provide minimum staffing levels for pre-analytical, analytical and post-analytical test performance. Method Performance / Validation Carryover for studies will meet CAP and CLSI guidelines. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (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 body fluids as applicable and must be approved by the medical director. Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range, shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum. Precision study using normal and abnormal control material. This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal controls. Intra-VISN facility variations should be kept at an absolute minimum. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge. A verification of the manufacturer s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects with medical director approval. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 40 reference individuals shall be used to verify the manufacturer s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification. If the suggested manufacturer s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method. If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed. Completion of Contract Ownership of Equipment - Title to the equipment shall remain with the Contractor unless otherwise agreed. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. Should The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. Delivery: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in section 1.6. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Contracting Officer Representative (Hereafter referenced as COR) shall be required to notify the Contractor when delivery locations have been changed. All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, IDIQ number, shipping address, delivery location, items/quantity ordered and items/quantity shipped. Standard orders shall be delivered within no more than 30 working days after receipt or placement of order. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please state your company s DUNS number. (9) Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (9) should show clear, compelling and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to Daniel.Ruiz@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Wednesday, March 30, 2022 at 12:00 p.m. PDT. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.
