Allergy Immunoassay Disease Testing SOW.docx

STATEMENT OF WORK

TITLE: Automated Allergy and Autoimmune Disease Testing CPT

I. SCOPE:

The Contractor shall provide a cost-per-test (CPT) fully automated autoimmune analyzer testing system, reagents, supplies, and consumables capable of performing FDA-approved patient testing for VISN 08 facilities, Tampa VA Healthcare Network (TVAHCN) and Bay Pines VA Healthcare System (BPVAHCS), Department of Pathology and Laboratory Medicine Service (P&LMS). P&LMS requires equipment in at least two (2) separate locations, including but not limited to, the following locations, with the flexibility and ability to expand testing / add instrumentation to future locations throughout the VISN Healthcare Network as needed to meet the healthcare system’s demand and growth:

1) Tampa VA Healthcare Network, James A. Haley Veterans Hospital (JAHVH), 13,000 Bruce B. Downs Blvd, Tampa, Florida 33612

2) Bay Pines VA Healthcare System, C.W. Bill Young VA Medical Center (CWBY VAMC), 10,000 Bay Pines Blvd, Bay Pines, FL 33744

The contractor shall provide equipment and test kits that meet all the minimum physical, functional, and performance features of the listed salient characteristics in this section. These salient characteristics are essential to the technical requirements to continue to meet the needs of the government.

All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances. FDA and manufacturer's guidelines, with all terms, conditions, provisions, schedules, and specifications provided herein. The Contractor selected is responsible for system installation, maintenance coordination and supply procurement for all equipment.

II. REQUIRED TEST MENU:

A. The Contractor shall provide all equipment, equipment operating systems, LIS interface, total lab automation (TLA) connection (as applicable / if available), and all other items defined within the CPT all-inclusive price as described herein.

B. Mandatory Test Menu by Facility: Annual test volumes are based upon prior history and are not a guaranteed. There shall be no minimum monthly or annual obligation.

Test Volume

CWBY VAMC

Test Volume Estimated Total Annual Volume

Test Volume

CWBY VAMC

Test Volume Estimated Total Annual Volume

Anti-neutrophil Cytoplasmic Antibodies (ANCA PANEL)

Antiphospholipid Syndrome (APS) PANEL

Celiac Disease PANEL

Autoimmune Liver Disease

Rheumatoid Arthritis Disease

Autoimmune Thyroid Disease

Connective Tissue Diseases

III. GENERAL REQUIREMENTS:

A. Cost per Test (CPT): Under the CPT contract, the contractor is required to furnish all of the following as a single price, standardized at all facilities, based on collective estimated test volumes:

1. All reagents and supplies necessary to operate the contractor's equipment for the testing menu as defined, including calibrators and or calibration material, reagents, reagent strips, linearity testing material, 2 levels of tests control material, disposables, consumables, cleaning solutions, diluent solutions, sheath fluids, and any instrument part required for operating all analyzers and equipment (as applicable to the test system and test menu).

ADDITIONAL NOTES:

· Contractor may be required to provide 3rd party controls at no additional cost to the government in case manufacturer controls do not meet Laboratory’s requirements.

· Contractor shall provide enough reagents sufficient to perform testing at each location for a minimum of 30 days.

· Reagent quality must be high enough to satisfy proficiency testing of the College of American Pathologists and the Joint Commission.

2. Software licenses and Interface to the Lab Information System / middleware.

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. 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.

8. Costs for the DI water system and system maintenance (if required).

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

10. Contractor to perform equipment and assay installation including 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).

a. Contractor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., Contractor is to provide all manpower and reagents/supplies to do correlation studies).

b. Accuracy studies for each analyte. A minimum of 30 samples, spanning the reportable range, will be run by the present and the new contracted method. Contractors will analyze numbers and provide statistical data to accept the new method. Statistics will consist of at least mean, bias, slope, y-intercept, correlation coefficient, analysis, and meet current standards defined by CLSI.

c. Linearity analysis will be performed on new contracted instrument(s) for each analyte to determine reportable range. A 5-point linearity analysis that adheres to the Beer Lambert Law should be performed as a minimum.

d. Precision study utilizing normal and abnormal control material will be performed. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control.

e. Calibration verification will be performed using samples of known value. These can be calibrators or CAP assayed survey samples, or equivalent.

f. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

g. Reference Range: Determine a reference range for each analyte following CLSI guidelines. Samples used for the reference range study shall be representative of the patient population being tested. Reference range assessment shall be performed for each lab. One of the following protocols should be used:

1) 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.

2) If the suggested manufacturer's range is not appropriate for the patient population, a reference range shall be established. Establishing a reference shall follow CLSI guidelines. This requires a minimum of 120 reference individuals be used to establish a reference range. The reference interval should be determined using the nonparametric method.

3) 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, then an alternate test shall be provided.

h. Therapeutic range validation studies shall be performed by Contractor for applicable analytes, using CLSI guidelines.

i. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Contractor will provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms.

j. All technical procedures shall be provided by Contractor on diskette in CLSI format, using software compatible with each Laboratory's computer system, for local modification to meet CAP requirements.

11. All shipping costs for reagents, consumables, supplies and equipment (install and removal at the end of contract) including delivery to the clinical laboratory at all sites. Note: includes emergency, overnight delivery as necessary.

12. Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery with no shipping expenses.

B. There shall be no minimum monthly or annual purchase requirements. CPT 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 a guaranteed minimum.

2. New tests will be added as requested as baseline cost per test (CPT) without instrumentation hardware and software or service costs added.

3. All reagents for instrument verification and test method validation, per The Joint Commission and VA guidelines, 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.).

5. Annual review of test volumes shall be done to determine accurate tiered pricing and/or the need to upgrade equipment based on increased workload. If necessary, a request for modification to the contract may be required to make the necessary changes to CPRR pricing and/or equipment.

IV. EQUIPMENT – SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES:

A. The vendor must provide NAME BRAND OR EQUIVALENT for all the following list of equipment:

1. Thermo Fisher Scientific – Phadia™ 250 Analyzer

2. AESKU.GROUP – Helios HTC System (CWBY VAMC ONLY)

B. Vendor to provide NEW state-of the art instrumentation hardware and software system necessary to product a test results (analyzers, operating system, UPS, etc.).

Note: Equipment to be billed as a separate line item: 50% at the time of delivery and 50% at the completion of installation and following the acceptance for use.

C. Vendor must include the following software licenses for the life of the contract. (CWBY VAMC ONLY) Note: Software licenses to be billed once annually for the life of the CPT contract.

1. End Point Titer Software License

2. ANA Pattern Recognition Software License

D. System preventative maintenance and Technical Service (including parts, labor, travel) to be billed annually as a separate line item for the life of the contract.

Note: Maintenance and Service to be billed once annually for the life of the CPT contract.

E. Minimum System Components Per Facility:

1. James A. Haley Veterans Hospital (JAHVH): One (1) complete, Thermo Fisher Scientific – Phadia™ 250 Analyzers, including table/wagon and plumbed drain kit.

2. C.W. Bill Young VA Medical Center (CWBY VAMC): One (1) complete, Thermo Fisher Scientific – Phadia™ 250 Analyzer, including table/wagon and plumbed drain kit and one (1) AESKU.GROUP – Helios® HTC System.

F. General System Requirements – Thermo Fisher Scientific – Phadia™ 250 Analyzer:

1. All equipment provided must be new.

2. System must come with a cart, wagon, or table for analyzers to sit on and capable of housing reagents.

3. System must be able to be plumbed directly to a floor drain.

4. Test Methodologies:

a. Allergy: ImmunoCAP™

b. Immunoassay: EliA™

5. Systems must be barcode driven (Code 39, Code 93, Code 128).

6. Test system must be a fully automated closed immunoassay system

7. Must be 100% “walk-away” system, monitoring during specimen analysis must be minimal.

8. Throughput: up to 60 results/hour

9. Sample Types: Serum and plasma

10. Must accept sample tubes: Height 50–110 mm and Diam. 10–17 mm

11. The system must be able to do onboard dilutions for both allergy and autoimmune testing.

12. The system must have a level and clot detection.

13. The system must have the capability to prioritize STAT testing.

14. On-board reagent storage: 180 Carrier Storage with 10-16 assays per carrier.

15. Calibration: One master isotype calibration curve per assay group (IgG, IgE, IgM, IgA) with storage up to 28 days.

16. The system shall come ready for Auto-verification of results.

17. The system shall suspend or turn off the Auto verification process automatically upon QC failures or QC time limits are exceeded.

18. Analyzers shall have accurate capability of monitoring reagent usage, and provide reagent inventory upon request, in real time.

19. An electronic operator’s manual shall be furnished with each model supplied.

20. Ambient Operating Temperature Requirements: Between I8 - 32° Celsius

21. Electrical Characteristics: Dedicated 120V, 20 Amp, 60 Hz circuit

22. Space (per instrument on table): 186 x 127 x 75 cm (HxWxD)

23. Weight: Less than 600lbs

24. Must have Remote Troubleshooting and Support

G. General System Requirements – AESKU.GROUP – Helios® HTC System (CWBY VAMC ONLY)

1. All-in-One, Fully automated solution

a. Process to reduce manual interventions and potential transcription errors

b. Processing and imaging reader on one system

c. Onboard system predilutions

d. Screening, reading, and titration

e. Pipette mounting media onto completed wells to preserve results

2. Throughput: Up to 190 samples, 20 slides, and 4 substrates per run

3. FDA-cleared to identify at least 7 immunofluorescence patterns and end-point titer analysis.

4. Must have an integrated LED microscope with automated digital image capturing

5. Customizable rack configurations

6. Must have an integrated humidity and temperate control (HTC) module to ensure standardization of humidity and temperature regardless of environmental changes.

7. Must have a controlled liquid management system ensures consistent incubation times and avoid cross-contamination.

8. Must connect to LIS for seamless reporting, reflexing, and remote confirmation.

9. Large digital library, reference images and pattern atlases assist with classification

10. Computer-aided interpretation to reduce overall imprecision over manual interpretation

11. Intuitive software to organize samples by fluorescent intensity for confirmation of negative results

12. Ability to archive digital pattern resolution images

13. Space: 30 in x 25 in x 22.5 in (tabletop)

V. SYSTEM DATA MANAGEMENT HARDWARE / SOFTWARE

A. For equipment with a virtual server or provided middleware: 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.

B. Ability to manage rules for optimal specimen handling.

C. Bidirectional Interface - shall be able to interface and automate the urinalysis instruments with orders and results separately for optimal transmission. Shall be capable of automatically uploading test results to the LIS. Expected optimal transmission shall include the capability to transmit backlog data due to LIS downtime at an acceptable rate of 500 test results uploaded/ 15 minutes.

D. Back up to network data management handling and hands-free barcode scanning.

E. System shall interface instruments to Data Innovations or directly to the LIS, Vista.

F. Data Management with record storage, including instrument used for testing, for all patient results.

G. Shall include all software and software licenses, interfaces, and hardware (e.g., servers, printers, printer drivers, monitors, UPS, etc.) required for complete system operations. Result and control reports must be available to be printed.

H. Computer Patient Data Handling: No hardware, containing any VA patient information is to be removed from either location, without the approval and removal of data by the VA Information Technology Department. Failure to comply with this VA requirement may result in prosecution.

VI. 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. Preventative maintenance tasks must be completed within 2 weeks of the due date, based on the date of the previously completed task.

VII. SERVICE AND SUPPORT

A. Contractor shall provide full service on-site technical support, Monday – Friday, excluding federal holidays, 8am-5pm, to keep the equipment in good operating condition and subject to security regulations.

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.

C. Remote Instrument monitor: If possible, Contractor shall provide remote access method to meet HIPPA and VA confidentially requirements for customer support staff and remote diagnostic services.

1. Customer Support Staff of the Contractor shall obtain a VPN (virtual private network) to be able to configure the system and allow for diagnostics and troubleshooting support services. Contractor staff with access to VA medical records shall provide satisfactory documentation of receiving HIPAA training and compliance with all HIPAA and VA patient confidentiality requirements.

2. An approved remote network communication system shall be provided, in accordance with VA Handbook 6500, Information Security Program, 2007, to continuously collect and monitor performance data of the analytical systems. *Contracting officer must verify before awarding a signed contract to the vendor* D. Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable the maintenance representative to receive such notification. The contractor will perform emergency repair service within 24 hours of time of notification of the malfunction except when an ordering facility elects reduced service at contract agreed reduction. The contractor will provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair will be borne by the contractor. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, at a minimum, the following: (a) date and time of notification (b) date and time of arrival (c) serial number type and model numbers(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 of the sample run.

E. During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the contracting officer representative (COR) of the government to request a replacement the initial laboratory equipment with new equipment.

F. Credit for Prolonged and/or Frequent Equipment Malfunction/Downtime: If a piece of equipment remains inoperative (unable to process patient specimens, perform patient testing, and/or report a valid test result) due to a malfunction through no fault or negligence of the government for a total of 48 hours consecutive hours or more, the contractor shall be assessed damages at the rate of 1/30 of the preceding average three month CPT billings times the total number of days certified as downtime for each incident. The downtime shall start from the time the user makes a bona fide attempt to contact the contractor's designated representative (technical support hotline) until the equipment is returned to good operating order.

G. Failure Mean Time Disclosure: The contractor will state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. In addition, the Contractor will help establish normal ranges. The Contractor will provide emergency backup equipment. Only instruments which are FDA approved will be considered and shall be operational and interface with VA laboratory computer systems and upgrades. This shall be a "tum-key" system.

VIII. 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. Initial delivery of analyzers, at the time of award, must be received at the laboratory within 14 days from date of award.

4. “Acceptance” will normally be achieved upon delivery of equipment and, when applicable, following installation/validation of equipment/assays and after the completion of personnel training.

5. 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

a. “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. 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.

b. Standard acceptable performance for the life of the contract 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 governments expectations, the government, through the contracting officer, may request a replacement of the equipment / assay or terminate the order upon mutual agreement.

c. Removal of the any existing vendor-owned instrument by the Contractor shall be performed within 30 days following the acceptance of replacement equipment without additional charge to the government.

d. 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.

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

6. 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.

7. Government's Responsibility: The trained user will perform 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. Site Preparation: Site preparation specifications shall be furnished in writing by the contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications.

3. Space Requirements, System Specifications, etc.:

a. System specifications shall all be disclosed in the proposed space with limited adjustments. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to manufacturer’s claimed specifications. Crossover from current to new instrumentation shall be performed timely with no interruption in patient care laboratory services.

b. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor.

c. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which involve additional expense to the government, shall be made at the expense of the contractor.

4. 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.

5. 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. If 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.

6. Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guaranteed date commencing ten calendar days after installation.

7. 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.

8. For Vendor-Owned Equipment Only: 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 assure 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 Joint Commission.

3. If 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). The Contractor shall reimburse each facility for any costs/supplies related to tests performed by another Contractor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

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. Items Included: The Contractor shall provide all routine and specialty items required to operate and maintain the equipment analyzer in optimal condition, such as but not limited to, standards, controls, calibrators, chemical test strips, printers, consumable equipment parts, and required replacement parts for maintenance or service. Any items excluded by the Contractor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of the any excluded items shall be disclosed in the price proposal.

6. 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.

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

IX. TRAINING

A. The contractor, without additional charge to the government, shall provide training on- or off-site for at least two (2) key operating personnel per instrument module installed and all automation system components at the time of installation of the contractor's equipment. The contractor will also supply two (2) additional key operator training slots per year throughout the life of the contract.

B. The contractor shall provide supplemental operating training to (2) two government personnel, 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.

C. Contractor shall provide, install, and train users on the data management system with either on- or off-site training. Additional training will be provided for 2 additional operators throughout the life of the contract.

D. 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.

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

A. Patient Mean Analysis Quality Control Program: QC program available to monitor trends of test methods required.

B. Comprehensive on-board QC Program, including Troubleshooting or System Validation QC material

1. Shall have quality control data storage and reporting capabilities

2. Shall have ability to view and print daily and monthly QC results.

3. Shall have ability to view and print Levy Jennings graphs.

4. Shall have ability to visually alert the operator of QC failures.

5. Shall have documentation of out-of-range QC troubleshooting.

C. Ability to lock out suppress test analytes if there are QC failures.

D. Automatic software upgrades by remote access without operator intervention.

E. Technology, reagents, and methodology that reduces need of manual sample manipulation such as pre-warming and pre-dilutions.

XI. 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.

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

XIII. 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.

XIV. 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.

XV. 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.

XVI. 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 VA Hospital Network records.

· does not include personal materials.

· applies to records created, received, or maintained by Contractors pursuant to their VA network contract.

· may include deliverables and documentation associated with deliverables.

c) Requirements:

1) Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2) In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3) In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4) VA Hospital Network and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA Hospital Network or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report VA Hospital Network. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5) The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA Hospital Network control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6) The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA Hospital Network guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7) The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA Hospital Network policy.

8) The Contractor shall not create or maintain any records containing any non-public VA Hospital Network information that are not specifically tied to or authorized by the contract.

9) The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10) The VA Hospital Network owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA Hospital Network shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11) Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

d) Flowdown of requirements to subcontractors:

1) The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2) Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

XVII. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

a) Access To Va Information and VA Information Systems:

1) Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2) A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

3) All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

4) The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

5) 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 all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

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 National Agency Check (NACI) with written inquiries.

Contractor Responsibilities:

· The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.The web site which provides information on the cost of the security investigation is: www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01) The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S.