36C24820Q0400-002.docx

36C24820Q0400

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24820Q0400 02-14-2020 Camille Alderman 813-972-2000 3133 03-02-2020 5 pm EST 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637 X 334516 1000 Employees N/A X Department of Veterans Affairs James A. Haley Veterans Hospital (90C) 13000 Bruce B. Downs Blvd Tampa FL 33612 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Tampa FL 33637

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page Vendor shall provide JAK2 Gene Mutation Analyzers Cost per test (CPT) in accordance with Statement of Need under B.4 and Price/Cost Schedule under B.2. The quantities of supplies are estimates only effective for Base plus Four Options:

Base Year 3/9/2020 - 3/8/2021 Option Year One 3/9/2021 - 3/8/2022 Option Year Two 3/9/2022 - 3/8/2023 Option Year Three 3/9/2023 - 3/8/2024 Option Year Four 3/9/2024 - 3/8/2025 Brand name or equal, salient characteristics under B.4.

Basis for award & Instructions to Vendors under Sect E.

Questions in response to solicitation must be emailed to Camille.Alderman@va.gov in bulleted format by 02/20/2020.

Email Quote, Technical specifications, and estimated Delivery and Installation date to Camille.Alderman@va.gov no later than 03/02/2020 5 pm EST.

See CONTINUATION Page X Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

BASE YEAR - GENE MUTATION PCR SYSTEM COST PER TEST TO INCLUDE: EQUIPMENT, REAGENTS, SERVICE, TRAINING, CONSUMABLES AND ANCILLARY ITEMS REQUIRED TO PRODUCE A HIGH-QUALITY PATIENT RESULT AND KEEP EQUIPMENT IN OPTIMUM CONDITION.

All line items Brand or Equal Qiagen, and in accordance with B.4 Statement of Need below.

BASE YEAR - TEST KIT, MOLECULAR BIOLOGY, JAK2 V617F / G1849T,PCR

MANUFACTURER PART NUMBER (MPN): 673633

BASE YEAR - TEST KIT, THERASCREEN, FGFR, RGQ, RT-PCR MANUFACTURER PART NUMBER (MPN): 874721

BASE YEAR - TEST KIT, THERASCREEN, PIK3CA, RGQ, PCR MANUFACTURER PART NUMBER (MPN): 873121

BASE YEAR - TEST KIT JAK2, PCR

MANUFACTURER PART NUMBER (MPN): 673613

BASE YEAR - STRIP TUBES AND CAPS

MANUFACTURER PART NUMBER (MPN): 981103

BASE YEAR - LOADING BLOCK 72 X 0.1 ML TUBES

MANUFACTURER PART NUMBER (MPN): 9018901

BASE YEAR - LOCKING RING,72 WELL ROTOR

MANUFACTURER PART NUMBER (MPN): 9018904

BASE YEAR - RNEASY, DSP, FFPE, KIT

MANUFACTURER PART NUMBER (MPN): 73604

BASE YEAR - QLAMP, DSP, DNA BLOOD MINI KIT

MANUFACTURER PART NUMBER (MPN): 61104

OPTION YEAR ONE - GENE MUTATION PCR SYSTEM COST PER TEST TO INCLUDE: EQUIPMENT, REAGENTS, SERVICE, TRAINING, CONSUMABLES AND ANCILLARY ITEMS REQUIRED TO PRODUCE A HIGH-QUALITY PATIENT RESULT AND KEEP EQUIPMENT IN OPTIMUM CONDITION.

OPTION YEAR ONE - TEST KIT, MOLECULAR BIOLOGY, JAK2 V617F / G1849T, PCR

OPTION YEAR ONE - TEST KIT, THERASCREEN, FGFR, RGQ, RT-PCR

MANUFACTURER PART NUMBER (MPN): 874721

OPTION YEAR ONE - TEST KIT, THERASCREEN, PIK3CA, RGQ, PCR

MANUFACTURER PART NUMBER (MPN): 873121

OPTION YEAR ONE - TEST KIT JAK2, PCR

OPTION YEAR ONE - STRIP TUBES AND CAPS

OPTION YEAR ONE - LOADING BLOCK 72 X 0.1 ML TUBES

OPTION YEAR ONE - LOCKING RING,72 WELL ROTOR

OPTION YEAR ONE - RNEASY, DSP, FFPE, KIT

OPTION YEAR ONE - QLAMP, DSP, DNA BLOOD MINI KIT

OPTION YEAR TWO - GENE MUTATION PCR SYSTEM COST PER TEST TO INCLUDE: EQUIPMENT, REAGENTS, SERVICE, TRAINING, CONSUMABLES AND ANCILLARY ITEMS REQUIRED TO PRODUCE A HIGH-QUALITY PATIENT RESULT AND KEEP EQUIPMENT IN OPTIMUM CONDITION.

OPTION YEAR TWO - TEST KIT, MOLECULAR BIOLOGY, JAK2 V617F / G1849T, PCR

OPTION YEAR TWO - TEST KIT, THERASCREEN, FGFR, RGQ, RT-PCR

OPTION YEAR TWO - TEST KIT, THERASCREEN, PIK3CA, RGQ, PCR

OPTION YEAR TWO - TEST KIT JAK2, PCR

OPTION YEAR TWO - STRIP TUBES AND CAPS

OPTION YEAR TWO - LOADING BLOCK 72 X 0.1 ML TUBES

OPTION YEAR TWO - LOCKING RING,72 WELL ROTOR

OPTION YEAR TWO - RNEASY, DSP, FFPE, KIT

OPTION YEAR TWO - QLAMP, DSP, DNA BLOOD MINI KIT

OPTION YEAR THREE - GENE MUTATION PCR SYSTEM COST PER TEST TO INCLUDE: EQUIPMENT, REAGENTS, SERVICE, TRAINING, CONSUMABLES AND ANCILLARY ITEMS REQUIRED TO PRODUCE A HIGH-QUALITY PATIENT RESULT AND KEEP EQUIPMENT IN OPTIMUM CONDITION.

OPTION YEAR THREE - TEST KIT, MOLECULAR BIOLOGY, JAK2 V617F / G1849T, PCR

OPTION YEAR THREE - TEST KIT, THERASCREEN, FGFR, RGQ, RT-PCR

OPTION YEAR THREE - TEST KIT, THERASCREEN, PIK3CA, RGQ, PCR

OPTION YEAR THREE - TEST KIT JAK2, PCR

OPTION YEAR THREE - STRIP TUBES AND CAPS

OPTION YEAR THREE - LOADING BLOCK 72 X 0.1 ML TUBES

OPTION YEAR THREE - LOCKING RING,72 WELL ROTOR

OPTION YEAR THREE - RNEASY, DSP, FFPE, KIT

OPTION YEAR THREE - QLAMP, DSP, DNA BLOOD MINI KIT MANUFACTURER PART NUMBER (MPN): 61104

OPTION YEAR FOUR - GENE MUTATION PCR SYSTEM COST PER TEST TO INCLUDE: EQUIPMENT, REAGENTS, SERVICE, TRAINING, CONSUMABLES AND ANCILLARY ITEMS REQUIRED TO PRODUCE A HIGH-QUALITY PATIENT RESULT AND KEEP EQUIPMENT IN OPTIMUM CONDITION.

OPTION YEAR FOUR - TEST KIT, MOLECULAR BIOLOGY, JAK2 V617F / G1849T, PCR

OPTION YEAR FOUR - TEST KIT, THERASCREEN, FGFR, RGQ, RT-PCR

OPTION YEAR FOUR - TEST KIT, THERASCREEN, PIK3CA, RGQ, PCR

OPTION YEAR FOUR - TEST KIT JAK2, PCR

OPTION YEAR FOUR - STRIP TUBES AND CAPS

OPTION YEAR FOUR - LOADING BLOCK 72 X 0.1 ML TUBES

OPTION YEAR FOUR - LOCKING RING,72 WELL ROTOR

OPTION YEAR FOUR - RNEASY, DSP, FFPE, KIT

OPTION YEAR FOUR - QLAMP, DSP, DNA BLOOD MINI KIT

B.3 DELIVERY SCHEDULE

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

60 Days ARO Equipment Delivery and Install All reagents, test kits, consumables, supplies, minimum 10 days ARO of order processing and order placement

B.4 STATEMENT OF NEED

1. GENERAL: The Contractor shall provide Molecular Diagnostics analyzers and reagents capable of running Phosphatidylinositol 3-Kinase Catalytic subunit Alpha (PIK3CA), Fibroblast Growth Factor Receptor 3 (FGFR) and United States Food and Drug Administration (FDA) approved Janus Tyrosine Kinase 2 (JAK2) genetic mutation assays at the James A. Haley Veterans’ Hospital (JAHVH), Tampa, Florida.

2. BACKGROUND: The JAHVH Molecular Diagnostics department of the Pathology & Laboratory Medicine Service has a requirement for Molecular Gene Mutation equipment and test kits.

3. PURPOSE: The FDA-cleared Janus Kinase 2 (JAK2) assay; will process mutation detection JAK2 valine-to-phenylalanine substitution testing at position 617 (V617F) allowing the JAHVH Molecular Diagnostic lab reliable detection of the JAK2 V617F/G1849T allele. The JAK2 V617F/G1849T allele is a genetic mutation, which when present, confirms the diagnosis of polycythemia vera disorder in patients.

4. SCOPE: James A Haley is requesting contractors provide brand name or equal equipment that meets or exceed the physical, functional and performance of the listed salient characteristics in this section. The equipment feature is essential to the technical requirements to meet the need of the government. James A. Haley is requesting a Reagent Usage (Cost Per Test) agreement to include instrument, supplies, installation, training, and service of the equipment (for life of agreement).

Scope inclusive of (a) laboratory instrument system, (b) reagents, (c) computer and accessories including UPS for the life of the contract, and (d) to include genetic mutation testing kits for PIK3CA, FGFR and FDA approved JAK2 testing. The kits will be determined by user based on tests to be performed, on a multiplexed molecular diagnostic testing platform featuring sample in and results out capability necessary to operate the contractor’s equipment, hardware and software upgrades, training for personnel and equipment maintenance necessary to fulfill the test requirements. James A Haley will select the equipment and associated package tailored to its requirements and only will pay for the test assays run on the contractor’s equipment (payment rate is at an established average “cost-per test” figure). Additional testing may be added based on Veteran care need and availability.

5. BRAND NAME QIAGEN OR EQUIVALENT: Below are the salient characteristics of equipment capable of meeting the VA needs. Vendor quote response must provide descriptive literature that meets the following specifications for PIK3CA, FGFR and FDA approved JAK2 instrument:

· A real-time cycler capable of deciphering complex class IV Single Nucleotide Polymorphisms (SNPs) by High Resolution Melting analysis (HRM).

· Fast ramping and negligible equilibration times for short run-times.

· Have high thermal and optical uniformity, with short equilibration times.

· The following testing performed on the instrument must be fully automated and available at the time of bid: To include but not limited to PIK3CA, FGFR and FDA approved JAK2 genetic mutation testing.

· General instrument characteristics include a simple, touch-screen user interface, with easy-to-use software.

· General instrument characteristics include, but not limited to a real-time nucleic acid amplification and detection system, which measures nucleic acid signals from amplified Deoxyribonucleic Acid (DNA) using fluorescent detection.

· With a choice of up to 6 excitation sources and 6 detection filters, combined with a short, fixed optical path, and can be used for multiplex reactions, ensuring minimum fluorescence variability between samples and eliminating the need for calibration or compensation.

· Fixed optical path ensuring consistent excitation of every sample, which means that there is no need to use a passive internal reference dye such as ROX.

· Minimum maintenance capabilities.

· Cost-effective and easy temperature-accuracy verification.

· Optical calibration not being required at installation, or when the instrument is moved.

· "Plug and play" connectivity between the computer and the instrument for ease of use.

· Physical characteristics: includes no more than 60 lbs., and the Dimensions (H x W x D) should be no more than 15" x 37" x 25" to accommodate our limited space.

· Capable of detecting at least 1 to 14 patients simultaneously.

· The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste. The system should not require monitoring during run and should be 100% “walk-away” system.

· All in one compact, benchtop unit.

6. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Equipment must provide the following functional and performance capability to ensure the false reading or results from the equipment during prevention of test:

· Accurate quantitation of the JAK2 V617F/G1849T mutation.

· FDA approved JAK2 Polymerase Chain Reaction (PCR) kit.

· The kit is for real-time PCR on real-time PCR instruments.

· The kit provides reagents optimized for reliable and sensitive detection and quantitation of the JAK2 V617F/G1849T mutation in genomic DNA.

· The FDA approved JAK2 sensitivity should have a limit of detection (LOD) of 0.042%.

· This optimal sensitivity should be able to be obtained on specimens containing at least 10,000 copies of the JAK2 gene (wild-type and V617F mutation).

· The FDA approved JAK2 Quant Kit should be a ready-to-use kit for the detection and quantification of the JAK2 V617F/G1849T somatic mutation due to a single nucleotide polymorphism.

· The FDA approved JAK2 Quant Kit should provide 4 plasmid standard dilutions for mutant JAK2 V617F and 4 for the wild-type JAK2 allele. Use of the standards enables accurate quantification of transcripts.

· Results are expressed as a percent of JAK2 V617F in total JAK2.

· FDA approved JAK2 Kit should include at least 24 reactions: V617F Positive Control, V617F Negative Control, 2 sets of standards plasmid dilutions JAK2 wild-type and JAK2 V617F, 2 Primers and Probe Mixes JAK2 wild-type and JAK2 V617F.

· Accurate quantitation of the phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation.

· Accurate quantitation of the FGFR mutation for urothelial cancer (UC).

The Cost per-test price includes costs covering (a) equipment use (reagent rental), (b) genotyping kits, (c) all necessary maintenance to keep the equipment in good operating condition, (d) operational hardware and software upgrades, (e) user training for government personnel, (f) yearly preventive maintenance per manufacturer’s recommendations, (g) complete service support, (h) reagents delivery cost. Contractor is required to provide delivery and installation of equipment at no additional charge. 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.

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.

All models shall perform satisfactorily at any laboratory temperature between 59- and 89-degrees F (15 and 32 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity <80% at 32C (89F) without condensation. An electronic operator’s manual must be furnished with each model supplied. Trade-in of existing equipment will be negotiated at James A. Haley, and not included in the scope of this contract.

Site Preparation specifications shall be furnished in writing by the contractor as 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 manufacturers claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation which are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor.

With all new equipment, Ownership of Equipment shall remain with the contractor for the life of the contract. 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 and turn in any hard drives containing VA sensitive information to VA IT. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days.

If new equipment is to be installed, the 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 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.

Operational use time for performance testing for a system is defined as the accumulated time during which the equipment 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.

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

7. GOVERNMENT’S RESPONSIBILITY: The user will perform daily routine operator maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

8. TRAINING OF OPERATING PERSONNEL: The contractor shall provide the services of a qualified technical person, at the time of new 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: (1) operation and care of equipment; (2) 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.

9. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE: The VA shall require the contractor to deliver the equipment ordered under this contract not later than SIXTY (60) calendar days after receipt of notice of award.

a. Reagents Delivery terms, Quality of Reagents, Supplies and Disposables: The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, monthly from call orders of a JAHVH representative. The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality slide product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC).

b. Installation procedures: 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 progress of the installation is interrupted through no fault of the contractor, the installation may be suspended until such time as the cause of delay has been eliminated. The Contractor shall resume the subject installation within 24 hours after the contractor has been notified.

10. MAINTENANCE: The contractor shall provide maintenance (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. Preventive maintenance by contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment.

11. SERVICE: Emergency repairs shall be performed within 24 hours after notification that the equipment is inoperative. The scheduled maintenance and service shall be performed by a qualified engineer with notice to the Contracting Officer Representative (COR). James A Haley normal business hour are 6:00 am - 6:00 p.m., excluding weekends and holidays. Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification. The contractor will provide all parts and labor needed to repair the malfunction. The travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the Government during this period.

The contractor shall furnish a malfunction incident report to the installation 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.

12. TRAINING AND TECHINCAL UPGRADES: Contractor is to provide a one-time training for two (2) operating personnel at installation of equipment. Contractor shall provide supplemental operating training to the 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.

13. WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.

14. DELIVERY SCHEDULE: All equipment and installation 60 days ARO. All reagents, test kits, consumables, supplies, minimum 10 days ARO of order processing and order placement.

15. PLACE OF DELIVERY: Warehousing Department, James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612.

SECTION C - CONTRACT CLAUSES

C.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[X] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509).

[] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

[] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a).

[] (ii) Alternate I (NOV 2011) of 52.219-3.

[X] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (JAN 2011) of 52.219-4.

[] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).

[] (ii) Alternate I (NOV 2011).

[] (iii) Alternate II (NOV 2011).

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

[] (ii) Alternate I (Oct 1995) of 52.219-7.

[] (iii) Alternate II (Mar 2004) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219-9, Small Business Subcontracting Plan (AUG 2018) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JAN 2017) of 52.219-9.

[] (v) Alternate IV (AUG 2018) of 52.219-9.

[] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).

[] (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2019) (15 U.S.C. 657f).

[X] (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C 632(a)(2)).

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (DEC 2015) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (DEC 2015) (15 U.S.C. 637(m)).

[] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[X] (26) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (OCT 2019) (E.O. 13126).

[X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (28)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[X] (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

[X] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (33)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[] (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C. 8259b).

[] (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[X] (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) [] (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (45) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[] (46) 52.225-1, Buy American—Supplies (MAY 2014) (41 U.S.C. chapter 83).

[] (47)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[] (ii) Alternate I (MAY 2014) of 52.225-3.

[] (iii) Alternate II (MAY 2014) of 52.225-3.

[] (iv) Alternate III (MAY 2014) of 52.225-3.

[X] (48) 52.225–5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (49) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[] (50) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

[] (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[] (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[] (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[] (54) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[X] (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

[] (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

[] (57) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (58) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

[] (60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

[] (ii) Alternate I (Apr 2003) of 52.247-64.

[] (iii) Alternate II (FEB 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[] (1) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495).

[] (2) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[] (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

[] (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

[] (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(iv) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115–232).

(v) 52.219–8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219–8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(vii) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(viii) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

(ix) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

(x) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

(xi) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

(xii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xiii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xiv)(A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

(B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvii) 52.222-54, Employment Eligibility Verification (OCT 2015) (E. O. 12989).

(xviii) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

(xix) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xx)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xxi) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxiii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

C.2 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 03/09/2020 through 03/08/2025.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause) Ordering officers (OOs) will be authorized to place orders against this agreement. The Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OOs, by separate memorandum upon issuance of the agreement. When OOs are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this Blanket purchase agreement. Any deviation from the terms of the agreement must be approved in writing by the CO responsible for this agreement. The Contractor shall accept orders against this agreement only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders.

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than , the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of ;

(2) Any order for a combination of items in excess of ; or

(3) A series of orders from the same ordering office within days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 15.