DRAFT SON - Chemistry CPRR and Automation .docx

DRAFT - STATEMENT OF NEED

TITLE: Chemistry CPRR with Laboratory Automation System

1. SCOPE:

The contractor shall provide Clinical Chemistry and Immunochemistry cost-per-reportable-result (CPRR) with clinical laboratory automation with instrumentation and software for an integrated, automated platform for flexibility, simplicity and improved productivity for the Tampa VA Healthcare Network (TVAHCN), Department of Pathology and Laboratory Medicine Service (P&LMS). P&LMS requires equipment at the following four (4) locations, with the ability to add future testing locations within the Healthcare System:

· James A. Haley Veterans Hospital (JAHVH), 13000 Bruce B. Downs Blvd., Tampa, Florida 33612

· New Port Richey VA Outpatient Clinic (NPROPC), 7900 Little Road, New Port Richey, FL 34654

· Lakeland Community-Based Outpatient Clinic (LCBOC), 2080 Meadowland Park Blvd, Lakeland, FL 33803

· Temple Terrace VA Clinic and Mental Health Facility (TTMHF), 8451 Temple Terrace Highway Tampa, FL 33637

All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the FDA and manufacturer's guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

2. REQUIRED TEST MENU (referred to as Attachment A):

a) Response must provide a completed Attachment A as evidence the proposed solution can meet the following:

1) At least 90% of the required test menu must be available on the vendor’s integrated chemistry / immunochemistry analytical system with FDA-approved vendor-specific reagents.

2) The proposed High-sensitivity Troponin assay must meet the IFCC definition of high sensitivity i.e. can be detected in at least 50% of normal reference population.

* Please note, volumes listed are estimated workload based on historical data and are not guaranteed minimums.

Shaded assays are not required but if available would be included in the final test menu.

CBOC

Tampa VA Mental Health Center

Estimated Annual Quantity

3. GENERAL REQUIREMENTS:

a) The contractor is required to furnish all of the following to all locations defined within the contract (as a single price, CPRR):

1) Instrumentation hardware and software (analyzers, track line system, operating system, UPS, etc.).

2) All Reagents, Calibrators, and Quality Control materials, including the use of 3rd-party Quality Control material at no additional cost to the government.

3) All consumables and user-defined replacement parts necessary to operate the contractor's equipment, including secondary, aliquot tubes.

4) Upgrades to and maintenance of hardware or software necessary to fulfill the test requirements.

5) On- and Off-site training for end users and key operators.

6) Delivery and installation of equipment at no additional charge as well as return shipping costs at end of contract (removal).

7) Equipment / assay installation and full validation of system hardware and software as well as assay performance studies (assay correlations to existing instrumentation, carryover, linearity, dilution validation, precision, accuracy, reference range studies, and normal range studies).

8) Complete system software verification, including initial rule build and validation, including but not limited to routing rules and auto-verification for the entire defined test menu. This applies to the initial test menu and any new assays added via modification of the contract throughout the life of the contract.

9) Automation system support for the modification to vendor software (track software) for the addition of or modification to 3rd-party connections.

10) Standard Operating Procedures (SOP) for all assays, maintenance tasks, and equipment operation shall be provided by the vendor.

b) CPRR pricing shall be based on the collective annual test volume for all 4 testing locations (same price regardless of test location).

c) The Tampa VA Healthcare Network facilities will only pay for the patient test results reported to the patient’s medical record. There shall be no minimum monthly charge.

d) CPRR shall be based on a tiered volume with additional savings as testing volume increases. Failure to adequately charge for estimated cost on volume as disclosed will not incur additional charges. Inflated reagent estimates if not consumed will not be charged.

1) Annual test volumes provided are based upon historical reported result data and are not guaranteed a minimum.

2) New tests will be added as requested as baseline cost per test (CPT) or reduced pricing on the cost per reportable result (CPRR) without instrumentation hardware and software or service costs added.

3) All Reagents, Consumables, Calibrators, Linearity, and Quality Control materials for instrument verification and test method validation, per CLIA, College of American Pathologists (CAP), The Joint Commission and/or VA guidelines (based on most stringent), are to be supplied by the contractor at no additional cost to the government.

4) If at any time during the contract period, testing for the defined test menu is not available on this list, the Contractor shall provide, or reimburse the government, any additional costs associated with the procurement of another source of satisfactory test performance (i.e. reference laboratory, alternate testing instrument, etc.).

e) Space Allocations per Facility:

Response must provide evidence the proposed solution can fit within the allocated space at all locations.

1) James A. Haley Veterans Hospital (within the shaded blue area)

2) New Port Richey VA Outpatient Clinic – Must fit within a 20’ by 7’ rectangular space

3) Lakeland Community-Based Outpatient Clinic – Must fit within a 16’ by 7’ rectangular space

4) Temple Terrace VA Clinic and Mental Health Facility – Both instruments must fit within a 13’ by 13’ square space with both instruments facing each other.

4. EQUIPMENT – SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES:

a) Minimum System Components Per Facility

1) James A. Haley Veterans Hospital

· A minimum of 4 clinical chemistry and 2 immunochemistry high-volume analyzers, configured and integrated to maximize throughput, productivity, and result turn-around time for estimated workload.

· Automated Track System for specimen processing, delivery, testing, and storage.

· Input module for pre-analytic processing, including sample aliquoting and labeling of aliquot tubes.

· Refrigerated specimen storage.

· Output Module for ambient temperature sorting / specimen storage.

· Minimum of two (2) online centrifuges.

· Minimum of one (1) online specimen de-capper for automatic de-capping of all specimen tube cap types, including but not limited to; rubber stopper, twist/screw cap, push/pull cap.

· Minimum of one (1) online specimen sealer/re-capper

2) New Port Richey VA Outpatient Clinic

· one (1) integrated Clinical Chemistry/Immunochemistry high-volume Analyzer

3) Lakeland Community-Based Outpatient Clinic

· one (1) integrated Clinical Chemistry/Immunochemistry Low-To-Mid-Volume Analyzer

4) Temple Terrace VA Clinic and Mental Health Facility

· one (1) integrated Clinical Chemistry/Immunochemistry low-to-mid-volume Analyzer

· one (1) Clinical Chemistry Low-To-Mid-Volume Analyzer

b) General Specifications – Clinical Chemistry Analyzers

1) Test Methodology – All clinical chemistry analyzers at all locations must utilize the same methodology, reagent cartridges/packs, and produce test results within equal normal ranges for continuity of testing and patient care as patients travel throughout the healthcare network.

2) Minimal (<1% of test menu) requirements for sample pre-treatment.

3) Must have the ability to continuously load reagents, consumables, and patient samples, quality control (QC), and Calibrators.

4) Must be able to front load samples directly onto the instrument.

5) Assay calibrators must have 3 or more points for 75% of the defined test menu, as required by manufacturer reagent package inserts.

6) Analyzers shall be capable of handling primary tube sampling from collection tubes of various sizes and from various manufacturers.

7) Analyzers shall be capable of sampling from tubes of various types, i.e flat-bottom, round-bottom, sample cups, pour-off tubes, false-bottom tubes, and tube inserts.

8) Analyzer must have clot detection with alert notification.

9) Analyzer must have the ability to repeat and reflex test, auto-rerun and auto-dilute.

10) Analyzer must have an open channel availability for adaptation of commercially available reagents not produced by the Contractor.

11) Reagents

· Reagents, calibrators, and quality control shall be ready to use for 98% of all materials.

· Reagent cartridges shall be interchangeable between High- and Low-volume analyzers.

· Onboard stability greater than 21 days for 90% of vendor-specific reagents.

· Assay incubation times not to exceed 30 minutes.

· Minimum onboard reagent cartridge positions

· High-volume Analyzers: Minimum of 60 per module.

· Low-To-Mid-Volume Analyzers: Minimum of 25 per module

· Barcode or RFID technology for rapid on-board reagent placement and tracking.

· Reagent quality control frequency must be once per 24 hours or less frequent (exception, does not apply to electrolytes).

· Reagent calibration frequency must be once per 24 hours or less frequent for at least 90% of vendor-specific reagents.

· Software system must be able to disable patient testing in the event of expired or failed QC per assay.

· Software system must allow reagent calibration and QC testing when assay is disabled for patient testing.

· Must have programmable onboard quality control for auto-run capability.

· System must have a method to minimize carryover risks and meet CLIA guidelines for acceptable carryover studies. (Carryover study to be provided by vendor at time of installation)

12) Throughput

· High-volume Analyzers: Minimum throughput (per module) of 1000 tests per hour.

· Low-To-Mid-Volume Analyzers: Minimum throughput (per module) of 450 tests per hour.

13) Electrical

· No minimum or maximum required.

· Must include a stand-alone UPS with replacements, as necessary to maintain normal operations.

· Response must specify required connection type.

14) Water Consumption

· Response must specify water consumption per analyzer.

15) Heat Production

· Response must specify heat production per analyzer.

16) Noise Production

· Response must specify water consumption per analyzer.

17) Printing Capability / Lab Reports

· The system must have the ability to print test results on a paper non-network connected printer in the event of a complete hospital network outage.

· The analyzer system must have the capability to produce a chartable patient report, including the following mandatory characteristics:

· Facility Name

· Facility Address

· Facility Laboratory Medical Director

· Laboratory CLIA Number

· Test Result

· Test Normal Reference Range

· Test Unit of Measure

· Test Critical Values / Flags

c) General Specifications – Immunochemistry Analyzers

1) Reagents, calibrators, and quality control shall be ready to use for 98% of all materials

2) Test Methodology – All immunochemistry analyzers at all locations must utilize the same methodology, reagent cartridges/packs, and produce test results within equal normal ranges for continuity of testing and patient care as patients travel throughout the healthcare network.

3) Minimal assays (<1%) have a requirement for sample pre-treatment.

4) Must have the ability to continuously load reagents, calibrators, quality control, consumables, and patient samples, quality control (QC), and Calibrators.

5) Assay calibrators must have 3 or more points for 80% of the defined test menu, as required by manufacturer reagent package inserts.

6) Must be able to front load samples directly onto the instrument.

7) Analyzers shall be capable of handling primary tube sampling from collection tubes of various sizes and from various manufacturers.

8) Analyzers shall be capable of sampling from tubes of various sizes, i.e sample cups, pour-off tubes, false-bottom tubes, and tube inserts.

9) Analyzer must have clot detection with alert notification.

10) Analyzer must have the ability to repeat and reflex test, auto-rerun and auto-dilute.

11) Analyzer must have an open channel availability for adaptation of commercially available reagents not produced by the Contractor.

12) Reagents

· Reagents shall be ready to use with minimum preparation time.

· Onboard stability greater than 21 days 90% of vendor-specific reagents.

· Immunoassay incubation times do not exceed 30 minutes for 90% or more of immunoassay reagents.

· Minimum onboard reagent cartridge positions

· High-volume Analyzers: Minimum of 45 per module.

· Low-To-Mid-Volume Analyzers: Minimum of 25 per module.

· RFID technology for rapid on-board reagent placement and tracking.

· Reagent quality control frequency must be once per 24 hours or less frequent.

· Reagent calibration frequency must be once per 15 days or less frequent.

· Software system must be able to disable patient testing in the event of expired or failed QC per assay.

· Software system must allow reagent calibration and QC testing when assay is disabled for patient testing.

· Should have programmable onboard quality control for auto-run capability.

13) Consumables

· System must use disposable sample pipette tips, provided by the vendor, for immunoassays to eliminate carryover risks.

14) Throughput

· High-volume Analyzers: Minimum of Minimum throughput (per module) of 200 samples per hour and/or an overall throughput of 600 samples per hour (2 or more modules combined).

· Low-To-Mid-Volume Analyzers: Minimum of 100 samples per hour per module.

15) Electrical

· No minimum or maximum required.

· Must include a stand-alone UPS with replacements, as necessary to maintain normal operations.

· Response must specify required electrical specifications and connection type.

16) Water Consumption

· Response must specify water consumption per analyzer.

17) Heat Production

· Response must specify water consumption per analyzer.

18) Noise Production

· Response must specify water consumption per analyzer.

19) Printing Capability / Lab Reports

· The system must have the ability to print test results on a paper non-network connected printer in the event of a complete hospital network outage.

· The analyzer system must have the capability to produce a chartable patient report, including the following mandatory characteristics:

· Facility Name

· Facility Address

· Facility Laboratory Medical Director

· Laboratory CLIA Number

· Test Result

· Test Normal Reference Range

· Test Unit of Measure

· Test Critical Values / Flags

d) General Specifications – Automation Track System Components – JAHVH Only

1) Response MUST provide evidence that the entire proposed chemistry / immunochemistry testing solution can meet the space requirements provided. The maximum allowable height for any component of the automation system is 95 inches (allowing an 18” clearance from the ceiling for regulatory purposes).

2) The proposed solution MUST have the ability to connect the Sysmex XN9000/9100 Hematology Analyzer to the proposed automation track creating a maximized efficiency. Additional 3rd-party / existing laboratory equipment connections will be considered, but not mandatory, to maximize full laboratory automation with multiple disciplines: Werfen Instrumentation Laboratory ACL Top 750 Coagulation Analyzer, DiaSorin Liaison® XL, ThermoFisher Phadia, and/or Bio-Rad BioPlex Multiplex Analyzer. Vendor shall include with their response, what 3rd party connections are currently available at the time of response to the RFQ.

3) Comprehensive Input Module with Integrated pre-analytical functions, including but not limited to,

· Minimum Throughput – up to 750 tubes per hour.

· Specimen tube type identification (including test/tube association verification)

· Must have an aliquot module to automate the aliquot process and labeling of aliquot tubes.

· Ability to verify the centrifugation status (spun vs. unspun)

· Ability to verify liquid sample volume (minimum sample volume)

· Ability to verify sample quality (hemolysis, lipemic and icteric)

· Must have method / process to prioritize the processing of STAT samples from input to analyzer for testing.

4) Refrigerated specimen storage:

· Minimum storage capacity – 20,000 sample tubes

· Maximum Height Allowed – 95 inches.

· Programmable for auto-disposal of specimens per defined criteria, i.e. specimen type, department, accession area, specimen UID, and/or test name.

· Storage module MUST have “as needed” access to stored specimens to prevent delays in additional testing or unnecessary phlebotomy due inability to access the stored specimens.

5) Ambient room temperature sorting/specimen storage

· Ability to sort specimens by defined criteria for disciplines not connected to the track, including specimens being sent to the reference laboratory.

6) On-line Centrifuge

· Minimum Throughput – up to 350 specimen tubes per hour.

· Must be capable of handling different tube sizes simultaneously.

· Must have adjustable time and RPM settings.

· Must be able to produce adequate centrifugation in 5 minutes or less for test performance of all assays.

7) On-line Specimen De-Cappers

· Must be able to remove the following types of specimen cap types, including but not limited to, rubber stopper, twist/screw cap, push/pull cap.

· De-capping must be in an enclosed environment to prevent biohazardous aerosols.

· Minimum Throughput – up to 1200 specimen tubes per hour.

8) On-line Specimen tube sealer/re-capper

· Must be capable of re-capping or sealing multiple sample tube types.

9) Complete Track Automation System

· The system must have the ability to route / process all chemistry specimens, including whole blood, pre-spun, uncentrifuged, and urine, simultaneously.

· The Track Control System Software must have the following capabilities: general line operation, retrieving specimens, sort specimens, and auto-disposal of old specimens.

· The system must be able to process/analyze STAT specimens from the input module to test completion in less than 45 minutes (to meet laboratory qualitative measures and hospital directives)

· Track systems which require the use of an air compressor, the vendor must provide a compatible air compressor, including all routine or unscheduled maintenance at no cost to the government. This includes replacement for the life of the contract.

e) Deionized Water System, as applicable.

1) The vendor must provide a deionized water system (at each location) compatible with the testing solution proposed, if required to operate the proposed equipment.

2) The vendor must provide a service contract to maintain the system, including scheduled maintenance, consumables, and repairs, per the manufacturers specifications, for the life of the contract, which is billable in annual installments.

f) Upgrades / Replacement of Equipment within the TLA System: Request for upgrades or replacement hardware/software, due to workload increase, excessive instrumentation failures will be evaluated as needed or at least annually with communication to the Contractor for modification of the contract. A high incidence of such problems with any equipment/analyzer or assay within the test menu supplied may indicate probable non-compliance with the terms of this contract and will entitle the government to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily.

1) “Downtime” is defined as any time the equipment is not available for patient testing due to malfunction, unacceptable quality control, software system errors, or hardware failures. This includes time used for end-user troubleshooting, conversations with technical support or on-site engineer repair/support.

2) Standard acceptable performance for the life of the contract, following acceptance as defined in section 8 below, is defined as a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification without prolonged downtime (>4 hours) per instance more than 3 times within 30 days or more than 10 instances of downtime (of any length of time) within 30 days. In the event the equipment or an assay does not meet the standard acceptable performance for 30 consecutive days, the government will notify the contractor of the ongoing unacceptable performance, and the performance will be monitored for an addition 90 consecutive days. If after 120 calendar days from the initial date of unacceptability, the vendor does not resolve the performance concerns to meet the government’s expectations, the government, through the contracting officer, may request a replacement of the equipment / assay or terminate the order upon mutual agreement.

3) Removal of the existing instrument by the Contractor shall be performed within 30 days following the acceptance of replacement equipment without additional charge to the government.

4) Enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

5) The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government.

g) Adding New Analyzers to the Total Lab Automation System: A contract modification may be used to connect additional laboratory equipment / analyzers to the TLA system. Upon completion of the modification, the contractor is responsible for providing technical support and applications specialist for the installation, connection, and/or validation of the modifications to the TLA system. Validations of the TLA system must be performed within the guidelines and acceptance criteria defined by the contractor. The COR will review all validation / installation documentation for acceptance. Enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days at no additional charge to the government.

h) Adding New Assays to the Existing Analyzers: A contract modification may be used to add additional assays to the existing test menu at any time during the contract period. Upon completion of the modification, the contractor is responsible for the assay installation and validation in accordance with Section 2, General Requirements for a CPRR contract. The assay shall be acceptable for use within 30 days from the completion of the contract modification.

5. SYSTEM DATA MANAGEMENT HARDWARE / SOFTWARE

a) The Data Management System must include a test environment and product account. The contractor is responsible for assisting the government with the initial virtual server build and on-going maintenance of both servers.

1) The system must have sufficient data storage for 2 years of workload data and provide immediate access to more than 7,500 patient records per day, including instrument identification (houses PHI and PII).

2) The Contractor’s equipment shall be compatible, or have the ability to, act as a pass-through to the government’s Data Innovations (DI) Instrument Manager for instances when the government’s DI is the primary rule management software. DI connection (driver provided by vendor) is required for all vendors. The contractor will work with DI to develop and maintain a fully functional driver (including upgrades), and pay any associated costs related to that driver, for the life of the contract.

b) The contractor is responsible for the complete system software verification, including initial rule build and validation, including but not limited to routing rules and auto-verification for the entire defined test menu. This applies to the initial test menu and any new assays added via modification of the contract throughout the life of the contract.

c) As the owner responsible of the track operating system, the contractor is responsible for assisting the government with track software modifications (i.e. routing rules) when 3rd-party connections are added and/or modified. The government agrees to assume the cost of connection license for any government-owned equipment that the government requests to connect to the track system.

d) The vendor must provide all non-network printers (and printer drivers), including all components for printer functionality and printing (excluding printer paper).

e) The contractor must provide all monitors (minimum 32”) for the vendor data management system (Command Center), as applicable.

f) All equipment / analyzers must have 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 CPRS/VistA.

g) Must have an HL7 (Health Level 7) interface in order to send comments to host.

h) Equipment shall be able to support barcode format code 128.

i) Equipment shall accept, at a minimum, 10 characters in specimen identifier that is alphanumeric.

j) Ability to manage rules for optimal specimen handling with ability to send automated comments based on the rules to patient host record. Linearity limits, repeats for critical value tests, review for specimen integrity and delta checks on previous patient results are examples of automatic rules functions required.

k) Shall be capable of supporting specimen integrity-based rules to cancel/edit tests based on the test performed and the interfering substance. Test notated as canceled shall transmit to the host along with the appropriate comment.

l) The contractor and lab information manager must have remote access connectivity for troubleshooting systems, interface connections, and analyzers. Contractors require network access to the instruments and to the interface manager. Contractor agrees to complete the VA required training as applicable and be knowledge of Information Security requirements specific to VA installations and work with government BioMed and OI&T personnel to meet these requirements.

m) Analyzers or software systems shall be able to access a network storage drive for backup or be able to work with VA to provide suitable backup solution. If needed, the VA agrees to provide the contractor with a local account. The device is not required to be on VA domain.

n) The contractor shall provide a minimum of 40 thin client middleware licenses, if applicable, for system access throughout the healthcare network.

o) The contractor’s system software must include a comprehensive Quality Control Data Manager or provide compatibility with Bio-Rad Unity Real Time Quality Control (QC) program. The proposed system must include real-time reports, printable monthly reports, and peer-group evaluations with like controls, instruments and assays.

p) All software and software licenses, interfaces, and hardware (e.g. servers, printers, monitors, UPS, etc.) shall be included with cost of hardware required disclosed for removal if needed.

q) Procurement of systems with unsupported operating systems is prohibited. Unsupported operating systems are software systems that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e., no further security patches will be released for the OS by the manufacturer after the OS end of life nor will be available by other methods such as extended warranty purchases from the OS manufacturer). If the proposed medical device runs an unsupported OS, the medical device vendor must provide a support plan for the device (i.e., purchase of extended warranty from the OS manufacturer, an upgrade path to a supported OS, etc.) prior to deployment of the system. Contractor is responsible for maintaining operating system software in compliance with VA TRM (Technical Reference Model) and agrees to upgrade or replace the OS for ongoing approval with OI&T and BioMed network guidelines.

6. PREVENTATIVE MAINTENANCE:

a) The contractor shall provide maintenance, at their expense (travel, labor and parts), to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services.

b) The preventive maintenance shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.

c) Contractor shall have remote access to system for troubleshooting purposes.

d) The contractor is responsible for performing all preventative maintenance, at their expense (as a part of CPRR pricing), for all intervals of Monthly – Annual, including bi-annual, to minimize operator intervention and maximize automated workflow thus resulting in less hands-on time and creating more flexibility to meet the changing demands of our lab.

7. SERVICE AND SUPPORT:

a) Contractor shall provide full service on-site technical support for all vendor-owned equipment, including the track automation system, to keep the equipment in good operating condition and subject to security regulations.

1) JAHVH: 12 hours/day, 7 days/week, including federal holidays.

2) NPROPC / LCBOC / TTMHF: 8 hours/day (8am-5pm), Monday – Friday.

b) Telephone technical support shall be available 24 hours/day, 7 days/week with follow-up on all calls within one hour of initial call. Following determination that service is required, technical on-site support must be provided within 24 hours, including weekends and holidays.

c) The government shall provide the contractor access to the equipment to perform the repair.

d) The contractor will provide all parts and labor needed to repair the malfunction.

e) Travel, per diem and other expenses associated with the repair will be borne by the contractor.

f) The contractor shall furnish a malfunction incident report to the institution upon completion of each maintenance call. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

8. DELIVERY, PERFORMANCE, INSPECTION AND ACCEPTANCE:

a) General:

1) The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract at all times and places throughout the term of the contract Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.

2) The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance.

3) Returned goods: The VA is responsible for inspecting all products shipped hereunder and will give the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor.

4) Standard and Acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order upon mutual agreement.

5) 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 fine 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.

6) During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

7) Government's Responsibility: The user will perform daily and weekly routine operation maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate daily records to satisfy the requirements of this paragraph.

b) Equipment:

1) The contractor is required to provide new state-of the art equipment. Previously used or discontinued models are not acceptable.

2) Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training.

3) The VA reserves the right to request a ninety (90) day test and evaluation of all pieces of equipment prior to placing a delivery order under the contract. If the test and evaluation is not successful as determined by the CO and COR, the VA will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.

4) The contractor shall be responsible for installation, which consists of in-house delivery, positioning and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

5) Upon completion of Installation Qualification (IQ) and Operation Qualification (OQ), the equipment will be turned over to the hospital for Performance Qualification (PQ). Final acceptance for use will be based upon acceptance criteria as defined by the Government and regulatory agencies. The contractor agrees to resolve any deficiencies in performance within ten (10) calendar days of written notification from the Government.

6) The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

7) Ownership of Equipment shall remain with the contractor. All equipment accessories (hardware and software) 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, will remove the equipment. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days. The hard drive will remain within the VA.

c) Reagents/Supplies/Consumables:

1) The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, as needed (including emergency over-night delivery orders) from CALL orders within 24 hours.

2) The contractor will ensure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The VA .

3) In the event that the supplies, to include consumables, are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order for priority delivery from the government activity. This will be done at no cost to the government and in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).

4) The Contractor is required to provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology or technology will be at the expense of the Contractor. Alert and Notification of all technical advisory recalls and, or alerts, prior to or simultaneously with field alerts should be forwarded to Laboratory Supervisor and the Laboratory Manager. On or about the first day of each month, the contractor will ensure that each site is furnished with sufficient consumable supplies to produce a volume of tests for that month. Separate deliveries of products will be shipped to each testing site, as applicable. Failure to reserve adequate inventory will result in default.

5) If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival of the monthly standing order and routine supplies are delivered.

6) All deliveries (routine and emergent) of reagents, supplies, consumables must be delivered directly to the laboratory at the expense of the contractor.

9. TRAINING:

a) The contractor, without additional charge to the government, shall provide training on- or off-site for the following list of key operating personnel. In addition, the contractor shall provide supplemental operating training, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. The contractor will also supply two (2) additional training slots per year throughout the life of the contract.

1) Clinical Analyzer Key Operator / Advanced Operation Training

· JAH: 8 Training slots initially, at the time of installation and 4 annually for the life of the contract

· NPR: 2 Training slots initially, at the time of installation and 1 annually for the life of the contract

· Lakeland: 2 Training slots initially, at the time of installation and 1 annually for the life of the contract

· TTMH: 2 Training slots initially, at the time of installation and 1 annually for the life of the contract

2) Automation / Pre-Analytic System

· JAH: 8 Training slots initially, at the time of installation and 2 annually for the life of the contract

· NPR: 2 Training slots initially, at the time of installation and 1 annually for the life of the contract

3) Data Management System – 2 Training Slots annually

b) Training of Operating Personnel: The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Representative (COR) to on-site orientation and training to designated personnel in: operation and care of equipment; techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training.

10. ADDITIONAL SYSTEM SUPPORT – Items are not required but are considered an ADDED VALUE

a) Data Management Support (Above and Beyond the requirements of Section 5 above)

1) Major software modifications and upgrades to meet changes in VA OI&T guidelines or laboratory operations shall be supported by the contractor with a predefined cost (rate per hour) at the time of contract award. The contractor is responsible for, at no cost to the government, any upgrades to meet Section 5 above, i.e. unsupported or unapproved operating systems on contractor-owned data management system or equipment.

b) Provide a Lean Workflow Analysis to create a LEAN process and adapt total lab automation, incorporating multiple lab disciplines for maximized productivity and efficiency.

c) Provide a New Workspace Solution at no cost to the government, including but not limited to, ergonomic workbenches / seating, storage solutions, and task lighting to maximize work processes in a limited footprint

11. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under.

12. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

13. MANUFACTURED PRODUCTS: Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. Shelf-life of all consumables shall be at least ONE YEAR from shipping date unless FDA requires different expiration date.

14. REFERENCE SPECIFICATIONS AND PUBLICATIONS: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

15. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

16. CONTRACT ADMINISTRATION DATA: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof.

17. RECORDS MANAGEMENT OBLIGATIONS

a) Applicability: This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

b) Definitions:

1) “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

2) The term Federal record:

· includes James A.