Inactive Total Small Business Set-Aside (FAR 19.5)

STATEMENT OF WORK AUTOMATED BLOOD GAS INSTRUMENTATION 16 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: This procurement is for the capital purchase of automated blood gas instrume... STATEMENT OF WORK AUTOMATED BLOOD GAS INSTRUMENTATION 16 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: This procurement is for the capital purchase of automated blood gas instrumentation. Contractor shall be the original equipment manufacturer, not an authorized dealer, distributor, or reseller of the proposed equipment. Instruments shall come with a one-year warranty that includes preventative maintenance and emergency service repair. Instruments will be procured for each of the VA facilities listed below: Clement Zablocki VA Medical Center (Milwaukee) William S. Middleton VA Medical Center Laboratory (Madison) Tomah VA Medical Center (Tomah) Oscar G. Johnson VA Medical Center (Iron Mountain) Edward Hines, Jr. VA Hospital (Hines Lab and Respiratory Therapy) Jesse Brown VA Medical Center (Jesse Brown Lab and Anesthesia) Captain James Lovell Federal Health Care System (FHCC) VA Illiana Health Care System (Danville) The following number of instruments will be procured for each facility: Facility Number of Analyzers Milwaukee 2 Madison 2 Tomah 1 Iron Mountain 1 Hines Lab 2 Hines Respiratory Therapy 3 Jesse Brown Lab 2 Jesse Brown Anesthesia 1 FHCC 2 Danville 2 Each facility procuring more than 1 instrument shall receive identical instruments. TEST MENU: Each facility will have varied assay requirements. Refer to Attachment A. Instruments offered must, at a minimum, be able to report the following assays: pH pO2 pCO2 Hemoglobin Hematocrit Sodium Potassium Chloride Ionized calcium and/or normalized calcium Glucose Lactic acid Base excess Bicarbonate Total carbon dioxide (TCO2) Oxygen saturation Co-oximetry GENERAL REQUIREMENTS: Primary analyzer(s) All instruments required will be designed primary instruments and shall meet the minimum requirements and technical specifications of this solicitation. Technical Features - The desired automated blood gas instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the capability of performing or reporting the following parameters (FDA approved) on arterial, venous, or mixed venous whole blood specimens: pH, pO2, pCO2, hemoglobin, hematocrit, sodium, potassium, chloride, ionized calcium and/or normalized calcium, glucose, lactic acid, base excess, bicarbonate, total carbon dioxide (TCO2), oxygen saturation and co-oximetry. The instrument must be able to perform the complete profile described above discretely by either direct or indirect (calculated) measurement and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI). In addition, the analyses must take place on a single instrument and a single specimen. Operational Features The instrumentation offered shall have the following: Safety features to avoid unnecessary exposure to biohazardous and chemical material. The volume of biohazardous and chemical waste generated by the equipment must be minimal and require a minimum amount of handling. A sampling system that is automatic, easy to operate, safe and can accommodate various sample types without any additional adapter devices. The sampling system must have: The ability to aspirate directly from a syringe and an evacuated blood collection tube without additional sample manipulation. The capability of walk away processing that negates the need for additional instrument prompting. An error detection system that promptly notifies the operator that a sample is not positioned properly or there is insufficient sample quantity. An early clot detection feature that immediately alerts the operator to the suspected existence of a fibrin clot in the specimen. Ability to prioritize STAT testing without compromising existing programmed testing. A consumable supply system that maximizes the efficiency and productivity of the equipment. Cartridge based reagent system. Reagent stability once on the instrument. Packaging that is maximized to accommodate the varying specimen volumes at each VA facility and does not require a frequent exchange of inventory on the instrument. Minimal wastage of cartridges. A quality assurance system that will: Automatically perform system checks and/or system calibrations in accordance with the minimum regulatory requirements. Allow the operator to preprogram the analysis of quality control material, if required. Perform automatic corrective action on the system if the results of the quality control testing are not acceptable. A diagnostic error detection system that will: Alert the operator to a calibration drift. Provide troubleshooting help, guiding the operator toward corrective action. If the assistance is in the form of computer tutorials, the system must have the capability to print the procedures. Minimal daily and periodic maintenance Cartridge and/or sensor replacement must be accomplished easily. The new cartridge and/or sensor must be operational within two (2) hours of replacement. An on-board information management computer system. The information management system must have: Windows 10 based software. Capacity to store a minimum of 1000 patient results in a database for immediate recall. A quality program that evaluates quality control material for acceptability, provides Levy-Jennings charts and internal and external (peer group) statistical analysis of the quality control data as well as stores records for a period of three months. An instrument maintenance tracking system must also be available with the capability to store these records for a period of two years. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. Contractor must be able to interface through Data Innovations Instrument Manager. The accuracy of the barcode reading must have less than a 1% 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, 15 characters in the specimen identifier that is alpha and/or numeric, depending on the site. Contractor shall supply the following documents for each analyzer proposed: VA Directive 6550 Appendix A Pre-Procurement Assessment MOU/ISA for Data Management systems that will require vendor access. FIPS-140-2 Certification if analyzer utilizes wireless technology. Hardware Features The instrumentation offered shall have the following: A sample path design that allows for easy fibrin clot removal without hardware disassembly. An on-board, adjustable screen/monitor that is easily readable. A total equipment footprint that, when installed in the laboratory, shall not impact the functionality / operations of that laboratory. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract. An uninterruptible power supply with line conditioner for each instrument provided under this contract. Upgrades to both the equipment hardware and software in order to maintain the integrity of the system and state-of-the-art technology at no additional charge to the Government during the warranty period. This requirement only applies to system upgrades that enhance the model of the equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. If the vendor obtains FDA approval for body fluid pH analysis, this assay will be readily available to VISN12 at no additional cost. Support Features The equipment models being offered shall be in current production as of the date this offer 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. Warranty shall include: Telephone technical assistance 24 hours a day/7 days per week. On-site service 24 hours per day, 7 days per week on all instruments placed. The maximum response time for on-site service will be 12 hours for all VA locations. All such arrangements must be coordinated between the Contractor and VA laboratory personnel. Labor, parts, and/or replacement equipment necessary to repair operational or mechanical breakdowns of instrumentation and ancillary equipment (i.e. printer, computer, scanner, etc.). Preventative maintenance shall be performed on-site as frequently as published in the manufacturer s operator s manual and within 2 weeks of the scheduled due date. 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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Commercial offerings - 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. Characterization of 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. 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 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 Attachment A Estimated Annual Volumes by Facility Facility Blood Gas Co-oximetry Electrolytes (Sodium, Potassium, Chloride) Glucose Lactic Acid Ionized Calcium Milwaukee 6000 6000 6000 7000 7800 7800 Madison 3660 3715 428 3851 7420 1017 Tomah 250 250 0 0 0 0 Iron Mountain 100 100 0 0 150 0 Hines Lab 0 0 0 0 0 5600 Jesse Brown Lab 3843 3843 3843 0 0 1318 Jesse Brown Anesthesia 576 576 576 576 0 0 FHCC 515 515 515 515 0 445 Danville 180 180 180 0 0 0 Hines Respiratory Therapy 5000 5000 5000 0 0 0

Inactive

STATEMENT OF WORK AUTOMATED BLOOD GAS INSTRUMENTATION 16 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: This procurement is for the capital purchase of automated blood gas instrume... STATEMENT OF WORK AUTOMATED BLOOD GAS INSTRUMENTATION 16 DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK SCOPE OF PROCUREMENT: This procurement is for the capital purchase of automated blood gas instrumentation. Contractor shall be the original equipment manufacturer, not an authorized dealer, distributor, or reseller of the proposed equipment. Instruments shall come with a one-year warranty that includes preventative maintenance and emergency service repair. Instruments will be procured for each of the VA facilities listed below: Clement Zablocki VA Medical Center (Milwaukee) William S. Middleton VA Medical Center Laboratory (Madison) Tomah VA Medical Center (Tomah) Oscar G. Johnson VA Medical Center (Iron Mountain) Edward Hines, Jr. VA Hospital (Hines Lab and Respiratory Therapy) Jesse Brown VA Medical Center (Jesse Brown Lab and Anesthesia) Captain James Lovell Federal Health Care System (FHCC) VA Illiana Health Care System (Danville) The following number of instruments will be procured for each facility: Facility Number of Analyzers Milwaukee 2 Madison 2 Tomah 1 Iron Mountain 1 Hines Lab 2 Hines Respiratory Therapy 3 Jesse Brown Lab 2 Jesse Brown Anesthesia 1 FHCC 2 Danville 2 Each facility procuring more than 1 instrument shall receive identical instruments. TEST MENU: Each facility will have varied assay requirements. Refer to Attachment A. Instruments offered must, at a minimum, be able to report the following assays: pH pO2 pCO2 Hemoglobin Hematocrit Sodium Potassium Chloride Ionized calcium and/or normalized calcium Glucose Lactic acid Base excess Bicarbonate Total carbon dioxide (TCO2) Oxygen saturation Co-oximetry GENERAL REQUIREMENTS: Primary analyzer(s) All instruments required will be designed primary instruments and shall meet the minimum requirements and technical specifications of this solicitation. Technical Features - The desired automated blood gas instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the capability of performing or reporting the following parameters (FDA approved) on arterial, venous, or mixed venous whole blood specimens: pH, pO2, pCO2, hemoglobin, hematocrit, sodium, potassium, chloride, ionized calcium and/or normalized calcium, glucose, lactic acid, base excess, bicarbonate, total carbon dioxide (TCO2), oxygen saturation and co-oximetry. The instrument must be able to perform the complete profile described above discretely by either direct or indirect (calculated) measurement and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI). In addition, the analyses must take place on a single instrument and a single specimen. Operational Features The instrumentation offered shall have the following: Safety features to avoid unnecessary exposure to biohazardous and chemical material. The volume of biohazardous and chemical waste generated by the equipment must be minimal and require a minimum amount of handling. A sampling system that is automatic, easy to operate, safe and can accommodate various sample types without any additional adapter devices. The sampling system must have: The ability to aspirate directly from a syringe and an evacuated blood collection tube without additional sample manipulation. The capability of walk away processing that negates the need for additional instrument prompting. An error detection system that promptly notifies the operator that a sample is not positioned properly or there is insufficient sample quantity. An early clot detection feature that immediately alerts the operator to the suspected existence of a fibrin clot in the specimen. Ability to prioritize STAT testing without compromising existing programmed testing. A consumable supply system that maximizes the efficiency and productivity of the equipment. Cartridge based reagent system. Reagent stability once on the instrument. Packaging that is maximized to accommodate the varying specimen volumes at each VA facility and does not require a frequent exchange of inventory on the instrument. Minimal wastage of cartridges. A quality assurance system that will: Automatically perform system checks and/or system calibrations in accordance with the minimum regulatory requirements. Allow the operator to preprogram the analysis of quality control material, if required. Perform automatic corrective action on the system if the results of the quality control testing are not acceptable. A diagnostic error detection system that will: Alert the operator to a calibration drift. Provide troubleshooting help, guiding the operator toward corrective action. If the assistance is in the form of computer tutorials, the system must have the capability to print the procedures. Minimal daily and periodic maintenance Cartridge and/or sensor replacement must be accomplished easily. The new cartridge and/or sensor must be operational within two (2) hours of replacement. An on-board information management computer system. The information management system must have: Windows 10 based software. Capacity to store a minimum of 1000 patient results in a database for immediate recall. A quality program that evaluates quality control material for acceptability, provides Levy-Jennings charts and internal and external (peer group) statistical analysis of the quality control data as well as stores records for a period of three months. An instrument maintenance tracking system must also be available with the capability to store these records for a period of two years. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. Contractor must be able to interface through Data Innovations Instrument Manager. The accuracy of the barcode reading must have less than a 1% 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, 15 characters in the specimen identifier that is alpha and/or numeric, depending on the site. Contractor shall supply the following documents for each analyzer proposed: VA Directive 6550 Appendix A Pre-Procurement Assessment MOU/ISA for Data Management systems that will require vendor access. FIPS-140-2 Certification if analyzer utilizes wireless technology. Hardware Features The instrumentation offered shall have the following: A sample path design that allows for easy fibrin clot removal without hardware disassembly. An on-board, adjustable screen/monitor that is easily readable. A total equipment footprint that, when installed in the laboratory, shall not impact the functionality / operations of that laboratory. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract. An uninterruptible power supply with line conditioner for each instrument provided under this contract. Upgrades to both the equipment hardware and software in order to maintain the integrity of the system and state-of-the-art technology at no additional charge to the Government during the warranty period. This requirement only applies to system upgrades that enhance the model of the equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. If the vendor obtains FDA approval for body fluid pH analysis, this assay will be readily available to VISN12 at no additional cost. Support Features The equipment models being offered shall be in current production as of the date this offer 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. Warranty shall include: Telephone technical assistance 24 hours a day/7 days per week. On-site service 24 hours per day, 7 days per week on all instruments placed. The maximum response time for on-site service will be 12 hours for all VA locations. All such arrangements must be coordinated between the Contractor and VA laboratory personnel. Labor, parts, and/or replacement equipment necessary to repair operational or mechanical breakdowns of instrumentation and ancillary equipment (i.e. printer, computer, scanner, etc.). Preventative maintenance shall be performed on-site as frequently as published in the manufacturer s operator s manual and within 2 weeks of the scheduled due date. 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. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Commercial offerings - 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. Characterization of 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. 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 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 Attachment A Estimated Annual Volumes by Facility Facility Blood Gas Co-oximetry Electrolytes (Sodium, Potassium, Chloride) Glucose Lactic Acid Ionized Calcium Milwaukee 6000 6000 6000 7000 7800 7800 Madison 3660 3715 428 3851 7420 1017 Tomah 250 250 0 0 0 0 Iron Mountain 100 100 0 0 150 0 Hines Lab 0 0 0 0 0 5600 Jesse Brown Lab 3843 3843 3843 0 0 1318 Jesse Brown Anesthesia 576 576 576 576 0 0 FHCC 515 515 515 515 0 445 Danville 180 180 180 0 0 0 Hines Respiratory Therapy 5000 5000 5000 0 0 0