Draft SON Microbial Incubation ID and Susceptibility CPT.docx

DRAFT STATEMENT OF NEED

TITLE: Microbial Incubation, Identification (ID) and Susceptibility Cost-per-Test (CPT)

1. SCOPE:

The contractor shall provide complete Microbiology Specimen Incubation, Identification and Antimicrobial Susceptibility (ID/AST) testing system cost-per-test (CPT) with automated instrumentation and software for an integrated, automated platform for flexibility, simplicity and improved productivity for the James A. Haley Veterans Hospital (JAHVH), 13000 Bruce B. Downs Blvd., Tampa, Florida 33612, Department of Pathology and Laboratory Medicine Service (P&LMS).

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:

The Vendor must be able to provide the following test menu as defined.

a) Microbiology Culture Specimen Incubation

1) Routine Blood Cultures (Aerobic and Anaerobic) – 15,000 sets annually

2) Fungal Cultures – 2,000 annually

b) Microorganism Identification / Antimicrobial Susceptibility (ID/AST)

1) Bacterial identification – 15,000 annually

2) Yeast identification – 2,000 annually

3) Bacterial Gram-positive and Gram-negative antimicrobial susceptibility – 15,000 annually

c) Mass Spectrometry (MS) for Microorganism Identification

1) Bacterial identification, Gram-positive and Gram-negative – 15,000 annually

2) Yeast identification – 2,000 annually

3. GENERAL REQUIREMENTS:

a) Under the CPT contract, the contractor is required to furnish all of the following:

1) New instrumentation hardware and software (analyzers, operating system, UPS, etc.).

2) All Reagents, Calibrators, and Quality Control materials, including the use of 3rd-party Quality Control material, as applicable. Vendor must provide an all-inclusive list with response to RFQ, including cost per unit, part number and quantities based on estimated test volume.

3) All consumables and user-defined replacement parts necessary to operate the contractor's equipment. Vendor must provide an all-inclusive list with response to RFQ, including part number, price per item, and quantities based on estimated test volume.

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

5) On- and/or 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 system operating 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) Standard Operating Procedures (SOP) for all assays, maintenance tasks, and equipment operation shall be provided by the vendor.

b) CPT pricing shall be based on the ESTIMATED annual test volume, with no expected minimum volume.

1) A tiered pricing structure should be utilized with additional savings as testing volume increases.

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

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

4) 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.

5) 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.).

6) Failure to adequately charge for estimated cost on volume as disclosed will not incur additional charges.

4. EQUIPMENT – SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES:

a) Microbiology Culture Specimen Incubators

1) Vendor must provide two (2) integrated blood culture automated analyzers for routine and fungal blood culture testing.

2) Must be fully automated with barcode label recognition capability for accurate identification of blood culture bottles. The equipment must provide scan error alerts.

3) Must have blood fill level sensor for each individual specimen media bottles for notification of over filled and under filled bottle (blood volume requirement).

4) Must have the ability to manage testing workflow of high-volume laboratory with over 400 individual bottle incubator capacity.

5) Must use plastic media bottle design for blood culture collection to reduce exposure to blood-borne pathogens.

6) Minimal maintenance and calibration requirements. All responses to the RFQ must include a list of all user-defined maintenance and estimated hands-on tech time / automated procedure times.

7) Faster time to detection (TTD) for positive blood cultures.

8) Audible and visual on-screen alerts for positive bottles.

9) Must include a Warning Light Tower, including the capability to have a remote warning in a separate room from the incubator.

10) Automatic unloading of final negative bottles in batch or on-demand.

11) Scalable instrumentation - capable of attaching additional incubator units to the primary analyzer if testing volume increases.

12) Environmental Requirements:

· Temperature Range: 59° to 82°F (or 15° to 28°C), with no wide temperature fluctuations

· Room Relative Humidity: 20% to 80%, non-condensing

13) Must have the following Reporting Capabilities:

· Contamination rates

· Blood volume tracking and bottle fill volume report

· Time to detection statistics

· Temperature monitoring report

· Calibration report

14) RFQ response must specify required electrical connection type.

15) RFQ response must specify water consumption per analyzer.

16) RFQ response must specify heat production per analyzer.

17) RFQ response must specify any water consumption per analyzer.

b) Microorganism Identification / Antimicrobial Susceptibility (ID/AST) Analyzers

1) Analyzer General Specifications:

· Vendor must provide 2 instruments for redundancy and to meet workload volume, one large capacity (> 100 cards) and one medium capacity (>50 cards) for the isolation of bacteria for automated identification and susceptibility.

· Both instruments must connect to one computer operating system or middleware.

· Both instruments must have bi-directional interfaces.

· Both instruments must be table-top models (table included).

· Must have full traceability with pre-applied barcodes.

· Must allow multiple users simultaneously from individual workstations.

· Must link patient demographics to patient results.

· Vendor shall provide all hardware and software for up to 10 workstations, including workstation barcode scanners.

· Must include a quality control module to manage, report and store quality control results.

· Must be able to search software for results by searches by patient demographics, bench, date tested, organism, technician, and accession number.

2) Systems must have the following, but not limited to, identification capabilities:

· Rapid microorganism identification (ID)

· Gram negative bacilli identification – >150 organisms

· Neisseria, Haemophilus and other fastidious Gram-negative bacteria identification – >30 organisms

· Gram positive cocci and bacilli identification – >100 organisms

· Anaerobic bacteria and coryneform bacteria identification – >75 organisms

· Yeast identification – >50 organisms

3) Systems must have Antibiotic Susceptibility Testing (AST) and resistance mechanism detection.

· Gram negative antibiotic susceptibility testing (AST) cards – >36 antimicrobials and Extended-spectrum-beta-lactamase (ESBL) tests

· Gram positive antimicrobial susceptibility testing (AST) cards

· Streptococci – >10 antimicrobials and ICR test

· Streptococcus pneumoniae – >15 antimicrobials

· Staphylococci &/or Enterococci – >20 antimicrobials, 2 high level aminoglycoside screens and Inducible clindamycin resistance (ICR) tests

· Fungal – Fluconazole antimicrobial susceptibility testing (AST) card for yeast susceptibility testing – At least 2 antimicrobials, including Candida auris.

4) Systems must have epidemiologic trending and reporting.

5) Systems must have resistance detection by phenotype identification.

6) Systems must have rapid, same-day antimicrobial susceptibility testing.

7) The systems must include a system that analyzes minimum inhibitory concentration (MIC) patterns and detects phenotypes for most organisms tested.

8) The system must have at least:

· 2,000 described phenotypes

· 20,000 MIC distributions

· 100 resistance mechanisms detected.

· 75 organisms

9) The systems must have an extended MIC range to detect low-level resistance.

10) The systems must have resistance-oriented results for rare phenotypes.

11) The systems must understand the antibiotic results to meet formulary requirements.

12) RFQ response must specify required electrical connection type.

13) RFQ response must specify water consumption per analyzer.

14) RFQ response must specify heat production per analyzer.

15) RFQ response must specify any water consumption per analyzer.

c) Mass Spectrometry (MS) for Microorganism Identification

1) Mandatory Methodology – Matrix Assisted Laser Desorption Ionization-Time of Flight (MALDI-TOF).

2) Instrument must be a table-top model (table included).

3) The system must provide the capability of performing rapid bacterial identification using MALDI-TOF technology for common, clinically relevant organisms including (but not limited to) Gram-positive, Gram-Negative, and Yeast without an offline extraction process.

4) Automated, continuous load

5) Walk-away system with the ability to load up to 15 slides.

6) Urgent slide prioritization for critical patient samples.

7) Fast, easy protocols including on-slide sample preparation for bacteria and yeast.

8) An average of at least 10 strains per species to represent microbial variability.

9) Option for single choice results with differentiation between closely related species.

10) Must have end-to-end traceability with automatic barcode scanning.

11) Must have Automated system calibration.

12) The system must have the ability to be connected to up to ten (10) workstations (sample prep stations) installed at individual benches in the lab for the set-up of the target slides.

13) The system must allow for full sample traceability using uniquely barcoded disposable target slides and software-based guidance to deposit samples.

14) Each target slide should have a dedicated QC control spot per acquisition group of 16 clinical samples.

15) The system must not need any further manual sample extraction steps other than on target slide addition of matrix (CHCA) for GP and GN or formic acid (FA) and matrix (CHCA) for Yeast.

16) The matrix (CHCA) and formic acid (FA) must be ready to use and light stable at +4C.

17) The system must report the ID result with a confidence value.

18) The system must be able to distinguish Streptococcus pneumonia from non-pneumococcal species of the Streptococcus mitis group.

19) The mass spec system must provide a mass range no less than 1Da – 500kDa.

20) The MALDI TOF system must have a linear flight tube (TOF) length of greater than 1.19 meters. The “time of flight” tube must accommodate a larger spectrum than is required for organism identification, so that the technology has the potential for expansion (i.e. antimicrobial susceptibility testing).

21) The MALDI TOF system must have the ability to run in both positive and negative ion modes (standards).

22) The MALDI TOF system must meet the minimum sensitivity of 250 amol Glu-Fib peptide, 250 fmol BSA protein with a resolution of 5000 FWHM ACTH 18-39 peptide.

23) Expiration dating period of the consumables shall not be less than six months at the time of delivery to the facility.

24) The system shall use disposable slides to avoid cross contamination.

25) Traceability of each sample on the slide is easy and flexible.

26) The system shall not require cleaning materials or decontamination of target slides for reuse.

27) The database must include clinically relevant microorganisms for the identification of samples from a clinical microbiology laboratory (common organisms isolated from human samples).

28) RFQ response must specify required electrical connection type.

29) RFQ response must specify water consumption per analyzer.

30) RFQ response must specify heat production per analyzer.

31) RFQ response must specify any water consumption per analyzer.

d) Upgrades / Replacement of Equipment: 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 governments 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.

e) 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 3, General Requirements for a CPT 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 production 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 patient records, including instrument identification (houses PHI and PII). 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.

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 is not required for vendor’s who connect directly to the government’s LIS and when the vendor’s middleware is the primary rule management software.

b) The contractor is responsible for the complete system software verification, including initial rule build and validation, including but not limited to test rules and auto-verification rules 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) The vendor must provide all printers, including all components for printer functionality and printing (excluding printer paper).

d) 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.

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

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

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

h) 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. Evidence of compliance with VA IT requirements must be submitted with RFQ response.

i) The contractor shall provide a minimum of 15 thin client middleware licenses, if applicable, for system access throughout the healthcare network.

j) 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.

k) 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. All scheduled maintenance must be completed within 2 weeks of the scheduled due date (based on previously completed task).

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

7. SERVICE AND SUPPORT:

a) 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.

b) Contractor shall provide full service on-site technical support, 7-days per week, 7:00am-7:00pm for all vendor-owned equipment to keep the equipment in good operating condition to prevent patient care delays.

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 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 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.

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, except for previously defined equipment (by model and serial number) at the time of contract award. 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) 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 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. In addition, 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. The contractor will supply two (2) additional training slots per year throughout the life of the contract.

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. 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.

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

12. 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.

13. 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.

14. 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.

15. 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.

16. 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. Haley Veterans’ Hospital Network records.

· does not include personal materials.

· applies to records created, received, or maintained by Contractors pursuant to their James A. Haley 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) James A. Haley Veterans’ 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 James A. Haley Veterans’ 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 to James A. Haley Veterans’ 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 James A. Haley Veterans’ 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 James A. Haley Veterans’ 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 James A. Haley Veterans’ Hospital Network policy.

8) The Contractor shall not create or maintain any records containing any non-public James A. Haley Veterans’ 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 James A. Haley Veterans’ 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 James A. Haley Veterans’ 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.

17. 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. citizenship and are able to read, write, speak, and understand the English language.

· The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address. The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

· The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

· Standard From 85P, Questionnaire for Public Trust Positions

· Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

· FD 258, U.S. Department of Justice Fingerprint Applicant Chart

· VA Form 0710, Authority for Release of Information Form

· Optional Form 306, Declaration for Federal Employment

· Optional Form 612, Optional Application for Federal Employment

· The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

· Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

b) VA Information Custodial Language:

1) Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

2) VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

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

4) The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5) The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

6) If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

7) If…