2023 ABG SOW.docx

DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

SCHEDULE OF ITEMS

VISN 23 Pathology & Laboratory Medicine Service Line (PLMS) has a requirement for a Reagent Rental or Cost per Test Indefinite Delivery Indefinite Quantity (IDIQ) for Blood Gas analyzers. The desired analyzers must have the capability of performing or reporting the clinical parameters as defined in the statement of work. As requirements change, facilities within VISN 23 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market. The instrument must be able to perform as described and meet the performance characteristics for accuracy and precision as defined by the Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

It is anticipated that this will be a multi-station standardization with VA facilities listed in this solicitation participating in the awarded contract. However, the awarded contract does not obligate any funds and there is no obligation to the Government to purchase covered products until the individual participating VA facility issues a task order.

Blood Gas analyzers will be required at the following sites:

Black Hills VA Health Care System, Hot Springs, SD Black Hills VA Health Care System, Ft. Meade, SD Central Iowa VA Health Care System, Des Moines, IA Fargo VA Health Care System, Fargo, ND Iowa City VA Health Care System, Iowa City, IA Minneapolis VA Health Care System, Minneapolis, MN Nebraska-Western Iowa VA Health Care System, Omaha, NE Royal C. Johnson VA Medical Center, Sioux Falls, SD

DEFINITIONS

Cost Per Test (CPT) – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and

(4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

Bench Top analyzer(s) – Equipment offered that shall fully support the scope of operations (minimal requirements). The analyzer is considered stationary and remains in one location, generally Laboratory or Respiratory Therapy. There is no requirement for mobility, but portable options may also be considered in lieu of a bench top analyzer. A battery back-up is highly desirable.

Portable analyzer(s) - Equipment offered that shall fully support the scope of operations (minimal requirements). The analyzer is considered portable and can easily be moved to any department without affecting overall performance. The analyzer need not be waived and should have a battery back-up at minimum. Inclusion of a portable cart is highly desirable.

TEST MENU

Bid Schedule by Facility

The estimated yearly quantity is provided by VISN 23 based upon the previous twelve (12) month historical data and is considered accurate and in good faith.

Each facility will be responsible for the payment and billing for the analyzer(s) in their own facility. Vendors are asked to submit their proposal in the following format which exemplifies the most advantageous pricing structure for the government:

CPT – a CPT price based on the individual facility’s annual volume and instrumentation mix.

Pricing for All Ordering Periods

Site Name: VA Medical Center, Minneapolis, MN Hours of Operation: 24/7 Bench Top or Portable Analyzer: Two identical analyzers are required (portable may be considered in lieu of benchtop analyzer if all requirements are met, no cart needed) Analyzer Testing Menu: pH, PCO2, PO2, Bicarbonate, Oxygen Saturation, Base Excess, HGB, HCT, Whole Blood Sodium, Whole Blood Potassium, Ionized Calcium, O2HB%, COHB%, METHB% Analyzer Highly Desirable Testing Menu: Lactate

Blood Gas without Co-oximetry

Estimated QC per month: 186 per each analyzer

Note: If the contractor requires a minimum monthly charge per analyzer, please specify the minimum monthly charge and/or the minimum number of tests.

If applicable:

Minimum monthly fee:

monthly fixed amount (Includes tests/month)

Contractor proposes the following equipment (manufacturer, model, catalog #, etc.) for the VA Medical Center, Minneapolis, MN:

Bench Top or Portable Analyzers (2):

Site Name: Royal C. Johnson VA Medical Center, Sioux Falls, SD Hours of Operation: 24/7 Bench Top Analyzer: One Bench Top Analyzer Testing Menu: pH, pH temperature corrected, pO2, pO2 temperature corrected, pCO2, PCO2 temperature corrected, Base Excess, Bicarbonate, TCO2, O2HB%, COHB%, METHB%, Oxygen Saturation, Ionized Calcium Analyzer Highly Desirable Testing Menu: Lactate, pleural fluid pH Portable Analyzer: None Required

Estimated QC per month: 110 per analyzer

Note: If the contractor requires a minimum monthly charge per analyzer, please specify the minimum monthly charge and/or the minimum number of tests.

If applicable:

Minimum monthly fee:

monthly fixed amount (Includes tests/month)

Contractor proposes the following equipment (manufacturer, model, catalog #, etc.) for the VA Medical Center, Sioux Falls, SD:

Bench Top Analyzer:

Site Name: Fargo VA Health Care System, Fargo, ND Hours of Operation: 24/7 Bench Top Analyzer: One Analyzer Testing Menu: pH, pO2, pCO2, Base Excess, Bicarbonate, TCO2, O2HB%, COHB%, METHB%, Ionized Calcium. Temperature correction option.

Desirable Testing Menu: Sodium, Potassium and Chloride-direct measurement option Portable Analyzer: Not required but optional if available.

Estimated Patient Tests/Year

Direct Electrolyte Panel (Na,K,CL)

Estimated QC per month: 100 per analyzer

Note: If the contractor requires a minimum monthly charge per analyzer, please specify the minimum monthly charge and/or the minimum number of tests.

If applicable:

Minimum monthly fee:

monthly fixed amount (Includes tests/month)

Contractor proposes the following equipment (manufacturer, model, catalog #, etc.) for the VA Medical Center, Fargo, ND:

Bench Top Analyzer:

Site Name: Black Hills Health Care System, Hot Springs, SD Hours of Operation: 24/7 (On call hours: Midnight – 0600) Bench Top Analyzer: One Bench Top Analyzer Testing Menu: pH, pO2, pCO2, Base Excess, Bicarbonate, TCO2, HGB, O2HB%, COHB%, METHB%, oxygen saturation

Estimated Patient Tests/Year

Estimated QC per month: 90 per analyzer

Note: If the contractor requires a minimum monthly charge per analyzer, please specify the minimum monthly charge and/or the minimum number of tests.

If applicable:

Minimum monthly fee:

monthly fixed amount (Includes tests/month)

Contractor proposes the following equipment (manufacturer, model, catalog #, etc.) for the VA Medical Center, Hot Springs, SD:

Bench Top Analyzer:

Site Name: Black Hills Health Care System, Ft. Meade, SD Hours of Operation: 24/7 (On call hours: Midnight – 0600) Bench Top Analyzer: One Bench Top Analyzer Testing Menu: pH, pO2, pCO2, Base Excess, Bicarbonate, TCO2, HGB, O2HB%, COHB%, METHB%, oxygen saturation

Estimated QC per month: 90 per analyzer

Note: If the contractor requires a minimum monthly charge per analyzer, please specify the minimum monthly charge and/or the minimum number of tests.

If applicable:

Minimum monthly fee:

monthly fixed amount (Includes tests/month)

Contractor proposes the following equipment (manufacturer, model, catalog #, etc.) for the VA Medical Center, Hot Springs, SD:

Bench Top Analyzer:

Site Name: Nebraska-Western Iowa Health Care System, Omaha, NE Hours of Operation: 24/7 Bench Top Analyzer: Two identical analyzers are required Bench Top Analyzer Testing Menu: pH, pCO2, pO2, HCO3, base excess, ctHb, sO2, FO2Hb, FCO Hb, FMet Hb Portable Analyzer: None required

Estimated Patient

Estimated QC per month: 100 per each analyzer, every 8 hours

Note: If the contractor requires a minimum monthly charge per analyzer, please specify the minimum monthly charge and/or the minimum number of tests.

If applicable:

Minimum monthly fee:

monthly fixed amount (Includes tests/month)

Contractor proposes the following equipment (manufacturer, model, catalog #, etc.) for the VA Medical Center, Omaha, NE:

Bench Top Analyzers (2):

Site Name: VA Medical Center, Iowa City, IA Hours of Operation: 24/7 Bench Top Analyzer: None Bench Top Analyzer Testing Menu: NA Portable Analyzer(s): Two Identical portable analyzers required (portable carts highly desirable) Portable Analyzer Testing Menu: pH, pCO2, Bicarbonate, Oxygen saturation, Hgb, Sodium, Potassium, Chloride, Glucose, Ionized Calcium, O2HB%, COHB%, METHB%, Lactate, Base excess

Estimated Patient

Estimated QC per month: 190 per each bench top analyzer

Note: If the contractor requires a minimum monthly charge per analyzer, please specify the minimum monthly charge and/or the minimum number of tests.

If applicable:

Minimum monthly fee:

monthly fixed amount (Includes tests/month)

Contractor proposes the following equipment (manufacturer, model, catalog #, etc.) for the VA Medical Center, Iowa City, IA:

Portable Analyzers (2):

GENERAL REQUIREMENTS

Operational Features Required tests: As listed in Bid Schedule by Facility Meet performance characteristics for accuracy and precision as defined by CLIA and CLSI standards including satisfactory CAP peer group comparison. All tests, except pleural fluid pH and creatinine, must be FDA approved; however, FDA approved pleural fluid pH and creatinine is considered highly desirable.

Multiple specimen types with direct aspiration from blood gas syringes and other blood collection tubes/containers.

Sufficient capacity to meet volume and service demands.

A quality assurance program that includes the following:

Automatically performs system checks and/or system calibrations in accordance with minimum regulatory requirements.

Allow pre-programming quality control material.

Automatically perform corrective action on the system if the results of the quality control testing are not acceptable.

Customizable quality control data review program. Data review program must be VA OI&T approved (if external) and training must be provided.

Ease of calibration with calibration stability and reduced calibration frequency. Automatic calibration is required. Calibrators must be traceable to NIST standard reference materials as stated by the Clinical and Laboratory Standards Institute (CLSI) and/or College of American Pathologists (CAP).

Effective clot detection to avoid instrument malfunction and inaccurate analysis.

An error detection system that promptly notifies the operator a sample is not positioned properly or there is insufficient sample quantity.

Data management system capable of storing at least 500 patients; however, larger storage is preferable.

The system must not have a wireless 802.11x or Bluetooth interface or the interface must be capable of being disabled.

A bi-directional, bar-coded computer interface with ability to read standard barcode format such as Code 128 and Code

39. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA Veterans Health Information Systems and Technology Architecture (VistA) hospital information system (HIS) (Refer to Brief Summary of VistA Functionality below) at the time of contract award. If the host system software requires the use of non-proprietary universal interfacing system to provide bi-directional interfacing capabilities, the VISN23 facility laboratories currently use Data Innovations. To achieve connection with those systems, the awarded vendor will be responsible for the cost of the interface. Refer to the following section entitled “Support Features – Computer Interfacing Requirements” for specific details.

Brief Summary of VistA Functionality 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.

VistA is very limited in its functionality to manage laboratory quality control, provide Levy-Jennings plots or administer an instrument maintenance program.

Minimal recurring preventative maintenance and time spent on routine maintenance (daily, weekly, monthly, etc).

Ease of operation with state of the art technology.

Barcode scanning required for operator, patient IDs, reagent and quality control lot numbers including expiration.

A consumable supply system that maximizes efficiency and productivity.

Ready to use reagents, when applicable Long reagent shelf-life of disposable units and components Ability to maintain reagent stability while on the analyzer Packaging that is maximized to accommodate the varying specimen volumes at each facility but does not require frequent exchange of on-board inventory.

Optional/Highly Desirable Features – The following are desirable features and are NOT required. More weight may be awarded at the time of technical review for Offerors with the ability to provide. However, in awarding the IDIQ, the VA may include some, all, or none of the optional capabilities at some, all, or none of the locations.

PC computer diskette of procedure manual or on-line procedure manual in the instrument software. Updates provided as system updates occur. The procedure manual shall be formatted in accordance with current, approved CLSI guidelines (QMS02-A6).

Multiple specimen types suitable for measurement (arterial, whole blood, capillary, mixed venous, venous, etc.).

Minimal reagent storage space preferred.

Hardware Features – The instrumentation must have the following:

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.

Built-in printer preferred.

An on-board, adjustable screen/ monitor that is easily readable.

An uninterruptible power supply with line conditioner for each instrument provided under this contract. Replacement uninterruptible power supply with line conditioners shall be provided as needed, at no additional charge, for the duration of this contract.

Support Features

Computer Interfacing Requirements –The fully operational/bi-directional interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system at the time of contract award. All facilities require interfacing and utilize Data Innovations.

The vendor is responsible for providing all hardware required for implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to the existing universal interface system. Likewise, the vendor will provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of the interfacing equipment is supplied in the chart below.

If there is any identifiable patient information stored on the equipment hard drive it must be destroyed by the VA. The equipment will be returned to the vendor minus any hard drives associated with the system or its subsystems. The VA must be able to retain the hard drives associated with the system or its subsystems.

If the site already has a universal interface box, the vendor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, serial convertors – DIGI, Lantronix, cables, software, etc.) to the universal interfacing system. If the site does not have a universal interface and one is needed to optimally interface the instrument, the vendor is responsible for the acquisition of the universal interface box and everything else needed to connect with VistA. If there are any software upgrades in the instrument during its life, the vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VistA.

Computer interface documents, technical specifications and supporting documentation will be reviewed by the VISN- 23 IT, Biomed, and ISO support group before any contract is awarded. The vendor (s) will identify any employees that will need access to the VA network to support the selected equipment and interfaces immediately upon award to begin the VA network access process, if applicable.

Remote Access for Troubleshooting - Remote access for system troubleshooting may be provided only through a Site to Site Interconnection Security Agreement/Memorandum of Understanding (ISA/MOU) with The Enterprise Security Operations (ESO) Specialized Device Security Division (SDSD).

Commercial marketing – 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 at the time of this solicitation. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Refurbished, used or current in house equipment is not acceptable.

Supplies – The vendor must provide all equipment, reagents, calibrators, linearity material, sufficient control material as described, consumable/disposable items, parts, accessories, shipping costs and any other item included on the list of supplies defined in the contract required to establish instrument operation. All shipping costs for all supplies shall be borne by the contractor and shall be included in the offer. A list of parts/consumables/components/reagents/etc. not included in CPT should be itemized and included for review.

Validation - The vendor will assist with the performance of all validation studies in accordance with CAP standards including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, analytic interference, and determination of sensitivity and specificity at no cost to the Government. The vendor shall supply assistance with the establishment or verification of site specific reference ranges for each analyte and specimen source, when appropriate. The vendor will perform all statistical analysis and report data in an organized, clearly comprehensible format.

Green Environmental Management System (GEMS) compliance - The vendor must be in compliance with Executive Order 13423 and 13514, Federal Leadership in Environmental, Energy and Economic Performance. The goal is to establish an integrated strategy towards sustainability in the Federal Government and to make reduction of greenhouse gas emission (GHG) a priority for federal agencies. Products and services should be energy efficient, water efficient, biobased, environmentally preferable, non-ozone depleting, contain recycled content, and be non-toxic.

The vendor must provide additional subsequent waste determination studies in the case of any new test or new test formulations.

Technical Support - The Vendor must agree to provide technical support as requested by the Facility Lab Medical Technologist and/or Respiratory Therapy. This technical support may include determining methods to dispose of waste in compliance with federal, state and local waste rules and regulations.

Training – The vendor must provide an instrument training program to all sites that is coordinated with and timely to the equipment installation sufficient to the size and scope of the facility’s services. Utilization of the training slots will be mutually agreed upon between VISN23 and the vendor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant at the cost of the vendor. The vendor shall also provide in- house training during implementation. Additional on-site training may be required to accommodate staffing changes.

Equipment Preventative Maintenance/Repair Service – The vendor must be able to provide emergency equipment repair and preventative maintenance on all bench top and portable instrumentation according to the following terms:

A technical assistance center must be available by telephone: 24 hours per day with a maximum call back response time of 2 hours.

Equipment repair service that cannot be completed through telephone assistance will require on-site repair by qualified personnel supplied by the contractor. On-site repairs will be conducted during business hours, Monday – Friday, 0800-1700. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the vendor, VA laboratory personnel and VA Engineering.

Preventative maintenance calls per year as required by vendor.

Emergency repair service within twenty-four (24) hours of the time of notification of the malfunction. Vendor to provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair are the responsibility of the vendor.

Each notification for an emergency repair service call will be treated as a separate and new service call.

A malfunction incident report shall be furnished to the installed site upon completion of the repair call. The report shall include, as a minimum, the following:

Date and time notified Date and time or arrival Serial number, type and model number of equipment Time spent for repair Description of malfunction and repair Proof of repair that includes documentation of sample run of quality control verifying acceptable performance.

During the contract period, 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 will be made by the designated representative of the Government at the using facility to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the contractor.

Upgrades – The vendor must provide upgrades to equipment hardware and operating system software in order to maintain the system to manufacturer’s specifications at no additional charge to the Government. These must 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 the “system upgrades” that enhance the model of equipment 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. 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.

Ancillary support equipment – The vendor will provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house analyzer (if necessary), universal interface equipment, UPS, printers etc. In addition, the vendor will include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables, stands, etc.

PROPOSALS

It is the intent of the Government to award to a single IDIQ contract without discussions.

The Government will entertain proposals only for new equipment. Consideration of used equipment or current in-house equipment will not be accepted in the proposal. Vendors will be evaluated on what they propose for Blood Gas analyzers and will not be evaluated on any other offers made in connection with other instruments or services the vendor may provide to the VA.

Vendors are asked to submit their base proposals outlining the proposed equipment and pricing information per site. This equipment configuration should be based on the vendor’s best recommendation for equipment that meets the operational activities, required efficiencies and productivity of a laboratory of the size and scope defined herein.

Vendor may have the opportunity to submit a “best and final” proposal during negotiations and discussions, if applicable.

The quantities listed in Bid Schedule by Facility are the VA’s best estimate and will be used to evaluate quotations. However, the VA does not guarantee to order these quantities – neither the total for the entire VISN, nor the separate quantities for each individual site listed above.

Calibration performed per CAP or manufacturer requirements at minimum.

Vendors must provide commercial literature and other information describing their compliance with the technical specifications, certification of commercially available vendor computer interface to the VA VistA computer system, equipment installation schedule and completed attachments. If commercial literature does not directly address specific specifications identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format.

Vendor must provide documentation that the instrumentation offered will perform analyses with the precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI).

Vendors must provide a description of all ancillary support equipment that is needed to operate the Blood Gas analyzers as defined in the specifications and offered as part of this agreement.