36C24726Q0645.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

VISN 7 Network Contracting Activity 501 Greene Street Hatcher Building - Suite 2 Augusta GA 30901

POINT OF CONTACT*

Contracting Officer Amanda Luckie Amanda.Luckie@va.gov

PLACE OF PERFORMANCE

1670 Clairmont Road Decatur, GA

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Department of Veterans Affairs, Network Contracting Office 07 (NCO 07), hereby provides notice of its intent to award a sole source, firm-fixed price task order under FAR Part 8, specifically GSAM Part 538.7104-3(b)(1)(ii) - Only One Source for CPT Hematology Analyzers to Sysmex America, INC., 577 Aptakisic Rd, Lincolnshire, IL 60069. This notice satisfies the posting requirements at FAR Part 5.1.

The contractor shall supply 2 hematology automated analyzers of the same type and model that is capable of accessing sample via an automated track. The analyzer must be able to provide all required parameters for a CBC’s and a 5-part WBC (white blood cell) classification known as a WBC differential via an automated system. The vendor/contractor shall provide an automated slide maker, stainer and a data management system containing user programmable rules.

The contractor shall provide hematology analyzers, service, repairs materials, data management system, technical assistance, reagents, quality control materials and a manual differential analyzer. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the performance work statement. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet 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). All test parameters currently available on current system to be continued. All parameters need to be FDA approved.

If the contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of the ATL VAMC. Preferred system should use state of the art technology, such as fluorescent flow cytometry for WBC, WBC differential, NRBC, reticulocyte and platelet identification and enumeration. It’s preferred that the system should offer fully reportable, FDA cleared immature granulocyte, providing a 6-part differential to provide more specific cellular information and to help reduce manual differentials. Preferring that the system offers fully reportable, FDA cleared Immature Platelet Fraction to assist with thrombocytopenia determinations. A system offering multiple on-board platelet methodologies is preferred to reduce manual reviews of flagged samples and platelet estimates.

NAICS code: 334516 (Analytical Laboratory Instrument Manufacturing) (size standard of 1,000 Employees).

PSC: Q515 (Medical- Pathology)

THIS IS NOT A SOLICITATION ANNOUNCEMENT. However, interested parties may identify their interest and capability to respond to this requirement within three (3) calendar days after publication of this notice. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for award and must submit a current authorized distributor letter from the manufacturer.

All Service-Disabled Veteran Owned and Veteran Owned Small Businesses must submit a self-certifying statement that their company meets all criteria established IAW 13 CFR 121.406(b)(1)(i) through (b)(1)(iii) thus demonstrating compliance with the Non-Manufacturer Rule.

Interested parties are encouraged to furnish information by email only with “RESPONSE TO INTENT TO SOLE SOURCE 36C24726Q0645” in the subject line. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to Amanda Luckie, Contracting Officer, by email at Amanda.Luckie@va.gov NO LATER THAN July 30th, 2026 @ 3:00 PM EST. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support these requirements.

See CLIN table below and provide the pricing information for market research purposes only.

PRICE/COST SCHEDULE

ITEM INFORMATION

CPRR based on 214,476 annual tests

LOCAL STOCK NUMBER: 15260

Appropriation: 508-3670160-2043-822300 Laboratory-2632 Other Medical and Dental-0100L0090

Cell Pack 20L Stk# DCL-300A

LOCAL STOCK NUMBER: 4002

Cell Clean Auto 20x4mL STK#CF579595

LOCAL STOCK NUMBER: 4003

XN Check 12x3 0mL Level 1,2,3 (4 each) STK#231499

LOCAL STOCK NUMBER: 4004

Flurocell Plt 2x12 mL STK#CD994563

LOCAL STOCK NUMBER: 4005

Flurocell RET 2x12 mL STK#BN337547

LOCAL STOCK NUMBER: 4006

Cell Pack DFL 2x1.5 STK#BT965910

LOCAL STOCK NUMBER: 4007

Flurocell WPC 2x12 mL STK#BU306227

LOCAL STOCK NUMBER: 4008

Lysercell WPC 2x1.5 STK#CS412800

LOCAL STOCK NUMBER: 4009

Flurocell WDF 2x42 mL STK#CV77552

LOCAL STOCK NUMBER: 4010

Lysercell WDF 5L STK#ZA90001

LOCAL STOCK NUMBER: 4011

Flurocell WNR 2x28mL STK#CP066715

LOCAL STOCK NUMBER: 4012

Lysercell WNR 5L (WNR-210A) STK#ZA900002

LOCAL STOCK NUMBER: 4013

Sulfolyser (5L) STK#SLS-220A

LOCAL STOCK NUMBER: 4014

CellPack DST 20L STK#DST300A

LOCAL STOCK NUMBER: 4015

Performance Work Statement Hematology Automated Analyzer

1.0 Background:

The hematology laboratory has a requirement to provide hematology services to the medical staff and VAHCS Atlanta patients. It is the intent of the Department of Veterans Affairs to establish a firm fixed task order for fully automated hematology instrumentation. The task order shall be Cost per Test (CPT)/Cost per Reportable Result (CPRR) and Clinical Laboratory Analyzers. The Government will award a CPRR task order to a single Contractor for automated Hematology instrumentation. The contractor agrees to the following terms of the task order exclusively with the Atlanta VA Health Care System and is awarded the final task order. Additional tests/reagents/instrumentation may be added to the task order as new technology becomes available.

Prices and terms:

Atlanta VAHCS will provide an estimated volume by test as reflected in Attachment A. Pricing is based on the average daily test volume. The Government estimates the volumes as listed in Attachment A but does not guarantee volumes as listed; they are estimates only. (Average increase of 10-15% yearly).

Term of agreement:

This will be a single award, firm-fixed price task order with one base year. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time there is a need to be a change in the contract. Please price a six-month extension after the end of the base and option years in case one is needed. If the Contractor fails to perform in a manner satisfactory to the CO, this task order may be canceled with thirty days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days’ notification to the CO. This task order shall be reviewed annually.

Ordering Method:

Atlanta VAHCS may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

Salient Characteristics:

The vendor/contractor will supply 2 hematology automated analyzers of the same type and model that is capable of accessing sample via an automated track. The analyzer must be able to provide all required parameters for a CBC’s and a 5-part WBC (white blood cell) classification known as a WBC differential via an automated system. The vendor/contractor shall provide an automated slide maker, stainer and a data management system containing user programmable rules.

Scope of Procurement:

The vendor/contractor shall provide hematology analyzers, service, repairs materials, data management system, telephone technical assistance, reagents, quality control materials and a manual differential analyzer. The desired instrumentation shall have the capability of performing or reporting have random access capability (if discrete testing is required) and the clinical parameters as defined in the performance work statement. The instrument shall be able to simultaneously perform the complete profile as described below and meet 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). All test parameters currently available on current system to be continued. All parameters need to be FDA approved.

If the contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of the ATL VAMC. Preferred system should use state of the art technology, such as fluorescent flow cytometry for WBC, WBC differential, NRBC, reticulocyte and platelet identification and enumeration. It’s preferred that the system should offer fully reportable, FDA cleared immature granulocyte, providing a 6-part differential to provide more specific cellular information and to help reduce manual differentials. Preferring that the system offers fully reportable, FDA cleared Immature Platelet Fraction to assist with thrombocytopenia determinations. A system offering multiple on-board platelet methodologies is preferred to reduce manual reviews of flagged samples and platelet estimates.

The contractor is required to provide a continuously stocked inventory of reagents, standards, controls, 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.

Special handling for emergency orders of supplies: In the event that the supplies are found to be defective or 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 regularly scheduled standing order/routine supplies delivery.

Definitions:

· Cost per Patient Reportable Result (CPRR) - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) five-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 of a patient reportable result. The cost per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (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 shall provide delivery, installation and removal of equipment at no additional charge.

· 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) five 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.

· 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) five 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. Primary Processing Automation Line – Pre-analytical processing equipment offered that will automate the pre-analytical specimen processing functions.

Equipment required:

A Hematology analyzer that can process a minimum of 60 patient samples per hour. The analyzer must produce acceptable CBC’s (Cell Blood Count) parameters to include a 5-part automated differential with abnormal flagging for immature granulocytes, blasts, indication of platelets clumping and other abnormal patient flags. Additional requirements will include a programmable data management system, an automated slide maker/stainer capable of receiving programmable rules, the system will be able to function as on or within an automation line. Slide maker/stainer should be physically connected as well as integrated with hematology analyzer decision rules to reduce operator hands-on, improve turn-around time, and reduce potential for error or injury from handling tubes of blood.

The vendor will provide manual digital automated differential analyzer. Integrated digital imaging devices are preferred to reduce operator handling and avoid error or exposure to biohazards. 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 Management System for the purposes of this solicitation, this is a separate component or module that electronically connects the testing instrumentation to manage data, results and workflow of two or more pieces of instrumentation. (Not to be confused with middleware for interfacing equipment with the hospital/laboratory information system (LIS).

· Barcoding stations located at key points along the line or track system must have the following capabilities:

· A barcode reading accuracy rate of 99% or greater for any component that requires barcode reading.

· Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

Testing Instrumentation – The testing instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

· Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A. The capability of performing analysis on the tests listed in Attachment A.

· Minimal personnel intervention for instrument maintenance, to reduce instrument downtime.

· A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

· An instrument management system (internal to testing instrumentation) that provides/maintains the following:

· On-board QC data management system with minimum storage capacity of QC files and includes Levy-Jennings graphs. Analyzer must have Ability to monitor instrument performance. The ability to capture, store and electronically transfer QC data. The ability to monitor instrument performance.

· Continuous monitoring of vital instrument functions with immediate operator notification of failure(s). A record(s) of the vital instrument function failure(s) must be maintained and stored electronically on-board the equipment.

· 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. 3 Level controls should include all instrument measurements for all whole blood parameters on system to reduce the various required control runs. Control should have the longest possible dating to minimize changes to controls. QC peer group data must have real time, automatic electronic data upload capability to analyzer quality control.

· Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

· Capability to capture, store and print the following information: instrument maintenance information, patient demographic information, and specimen results.

· On board reagent inventory management system, must have. Preferred system would offer a means to reduce reagent handling and inventory levels. This system can provide benefits though less handling of heavy reagent cubes, and less storage space required. The reduction of reagent packaging is also environmentally friendly.

· A system that provides reagent data to include but not limited to lot number, expiration date, and the number of remaining tests available for use on the analyzer (per analyte).

· Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology. A barcode reading accuracy rate of 99% or greater.

· Minimal operator intervention when introducing a STAT specimen or when changing a routine specimen to a STAT specimen. The introduction of a STAT specimen must not compromise existing programmed testing.

· On board reagent stability, sufficient to accommodate both high and low volume use. Minimal, or no reagent preparation (ready to use). The ability to detect and alert operators of low liquid levels and the potential of depletion.

· The capability to store, print and retrieve calibration data

· The ability to continuously load patient specimens.

· The ability to detect short samples-- clot detection and alert notification.

· Primary tube sampling from evacuated collection tube from various manufactures.

· The capability to program a test to perform a repeat analysis. The repeated analysis test result must be able to cross the interface and overlay the initial results.

· Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

· Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. Minimal Carryover. Long Calibration Stability (6) months.

· Contractor Middleware Management System must have sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.

· Ability to monitor patient moving averages; to stop validation of assays on individual analyzers if out of control

· 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).

· Integrated QC management tool to monitor and track QC; automatically suspend verification and instrument download by parameter in the event of a QC failure.

· The contractor shall collaborate with the lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

· The contractor shall assist customers with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

Hardware Features- The instrumentation shall have the following:

· All monitors/screens will clearly display information in all light conditions.

· A printer(s) that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

· An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units 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.

· Specific equipment requirements:

· Patient testing is disabled if QC failure occurs.

· The technology to electronically transmit quality control and instrument function checks and maintenance information to the Contractor Middleware Management system.

· The technology to print results in real time or on demand, as well as an option to print exception reports held in the middleware for auto verification purposes.

· Equipment relocation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost.

· Quality Control material is not required to be included in this task order; however, the CPRR price shall include assayed control products for lot changes and troubleshooting purposes.

2.0 Method Performance/Validation Requirements

Method performance/comparison shall be at the expense of the contractor, shall include linearity material and reagents, and be consistent with current the Clinical and Laboratory Standards Institute (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 laboratories to include serum, plasma, urine and body fluids, as applicable. These validation requirements are applicable to all new testing analyzers. Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range shall be run comparing 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 Clinical and Laboratory Standards Institute (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.

Precision study using normal and abnormal control material. This shall include, at a minimum, within-run precision study of ten normal and ten abnormal controls.

Sensitivity may be validated concurrently with correlation studies and 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.

Reference Range- A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

· 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. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 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 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.

Support Features

· 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. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

Start-Up Reagents

· The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this task order. The Contractor shall perform/assist, 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; to include new tests added to the test menu (contract modification), and the event of a reagent upgrade (new generation). The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section above and provide a hard-copy of data in an organized, clearly comprehensible format. The contractor will perform all the validation studies that are required, as determined by the laboratory director or designee.

Training – In addition to the training above, the following shall be provided:

· Basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable.

· Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization.

· The Contractor shall provide initial instrument hardware and software training, ongoing in-service training required for the routine operation of the instrument, printers, automation lines, refrigeration and other associated hardware as well as provide symposiums and Leaders Forum to enable operators, supervisors and managers keep up to date of advancements in testing and quality assurance. The training will ensure that VA is capable of performing routine servicing of hardware. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

Service Requirements

· Equipment Preventative Maintenance/Repair Service - The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, etc. offered according to the following terms:

· Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within two weeks of the scheduled due date. The vendor/contractor shall have proven experience or previous VA contracts and expertise in:

· Performing preventative maintenance (PM) bi-annually at a time mutually agreeable between the contractor and Contracting Officer’s Representative (COR). PM’s will be performed in accordance with the manufacturer’s instructions and will include, as a minimum, the following:

· Visual Inspections

· Calibration Checks

· Cleaning and Lubrication

· Performance Checks

· A technical assistance center shall be available by telephone 24 hours per day, seven days per week with a maximum callback response time of 1.0 hour(s).

· 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 and minimally equivalent to the terms and conditions for training defined in the Contractor’s Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator 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.

· Equipment repair service shall be provided during core business hours (8am to 5pm). Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

· Equipment repair response time shall be no more than one hour.

· 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 on repairs

· Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

Upgrades:

The contractor shall provide upgrades to both the equipment hardware and software 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 upgrades” that enhance the model of 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 Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the task order; however, it does refer to significant changes in the hardware operational capability.

Ancillary Support Equipment:

The Contractor shall provide, install and maintain through the life of the task order, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), printers, compressor (automation line) 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.

Interface Requirements:

· The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system.

· The Contractor shall provide all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

· If a site already has a universal interface system, the contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

· If there are any software upgrades in the instrument during its life, the contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

· The specimen management system must be computer interface compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

· 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 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 on 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.

The contractor shall provide a description of all waste 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, corrosiveness, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review.

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 the waste from each device can legally be disposed of via the sewerage system.

· Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the task order. This timeline is based on a reasonable attempt of the contractor to complete all of the necessary implementation requirements within the stated timeframe. The contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the contractor and is a result of delays due to the Government.

Upon award of the task order, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

The contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded task order including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate task order for cause under the Termination for Cause clause of the task order.

· Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the task order 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 installation 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 any proposal 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 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 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.

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 task order, should the repair record of any individual piece of laboratory equipment reflect a downtime of ten percent or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer 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. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this delivery order, i.e., water system UPS, etc.

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.

Ownership of Equipment Title to the equipment shall remain with the Contractor. 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.

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.

Prior to termination or completion of this task order, the contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this task order without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the task order.

All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the task order or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction, or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the task order or disposal or return of the IT equipment, whichever is earlier.

· Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

· Contractors must accept the system without the drive;

· VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or

· VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

· Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

· Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order.

· A statement needs to be signed by the Director (System Owner) that states that the drive cannot be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

3. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access.

· Position Sensitivity – The position sensitivity has been designated as Low Risk.

· Background Investigation – The level of background investigation commensurate with the required level of access is minimum background investigation.

Contractor…