36C24821Q0333_1.docx

36C24821Q0333

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

36C24821Q0333 01-25-2021 Walida Moore - walida.moore@va.gov 813-631-2856 02-09-2021 4pm

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 X N/A X Department of Veterans Affairs James A. Haley Veterans Hospital (90C) Warehouse 13000 Bruce B. Downs Blvd Tampa FL 33612 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Suite 525 8875 Hidden River Pkwy Tampa FL 33637

TBD

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page Real-Time (RT) polymerase chain reaction (PCR) analyzer and reagents for cancer and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection Cost Per Test IAW Statement of Need under B.4.

Quoters please see Instructions under E.4 and Evaluation under E.5.

Questions in response to this solicitation are due no later than February 1st , 2021 . Submit questions in bulleted format, reference paragraph in statement of need.

Quote due no later than February 9th, 2021 by 4PM EST.

See CONTINUATION Page X X Camille Alderman 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 Contract Specialist walida.moore@va.gov 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

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment, service, maintenance, training and reagents required to produce a high quality patient result and keep equipment in optimum condition. Qty 1: One Idylla console with 6 CE-IVD, Product # P0010. Includes Idylla Service Contract Gold, Product # S3019.

ALL LINE ITEMS ARE BRAND NAME OR EQUAL IAW BELOW STATEMENT OF NEED. THIS LINE ITEM IS FOR ESTIMATED QUANTITIES.

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

BRAF Mutation Assay

THIS LINE ITEM IS FOR ESTIMATED QUANTITIES.

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): A0011/6

KRAS Mutation Assay

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): A0021/6

EGFR Mutation Assay

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): A0061/6

NRAS3 Mutation Assay

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): A0031/6

MSI Mutation Assay

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): A0101/6

GeneFusion Assay

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): A0121/6

SARS-CoV-2 Assay (COVID-19 Testing)

Contract Period: Base POP Begin: 03-21-2021 POP End: 09-30-2021 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): A1043/6

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment, service, maintenance, training and reagents required to produce a high quality patient result and keep equipment in optimum condition. Qty 1: One Idylla console with 6 CE-IVD, Product # P0010. Includes Idylla Service Contract Gold, Product # S3019.

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022

BRAF Mutation Assay

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

KRAS Mutation Assay

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

EGFR Mutation Assay

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

NRAS3 Mutation Assay

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MSI Mutation Assay

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

GeneFusion Assay

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

SARS-CoV-2 Assay (COVID-19 Testing)

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment, service, maintenance, training and reagents required to produce a high quality patient result and keep equipment in optimum condition. Qty 1: One Idylla console with 6 CE-IVD, Product # P0010. Includes Idylla Service Contract Gold, Product # S3019.

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023

BRAF Mutation Assay

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

KRAS Mutation Assay

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

EGFR Mutation Assay

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

NRAS3 Mutation Assay

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MSI Mutation Assay

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

GeneFusion Assay

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

SARS-CoV-2 Assay (COVID-19 Testing)

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment, service, maintenance, training and reagents required to produce a high quality patient result and keep equipment in optimum condition. Qty 1: One Idylla console with 6 CE-IVD, Product # P0010. Includes Idylla Service Contract Gold, Product # S3019.

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024

BRAF Mutation Assay

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

KRAS Mutation Assay

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

EGFR Mutation Assay

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

NRAS3 Mutation Assay

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MSI Mutation Assay

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

GeneFusion Assay

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

SARS-CoV-2 Assay (COVID-19 Testing)

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment, service, maintenance, training and reagents required to produce a high quality patient result and keep equipment in optimum condition. Qty 1: One Idylla console with 6 CE-IVD, Product # P0010. Includes Idylla Service Contract Gold, Product # S3019.

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025

BRAF Mutation Assay

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

KRAS Mutation Assay

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

EGFR Mutation Assay

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

NRAS3 Mutation Assay

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MSI Mutation Assay

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

GeneFusion Assay

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

SARS-CoV-2 Assay (COVID-19 Testing)

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

B.3 DELIVERY SCHEDULE

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

813.972.2000 x4914 Anna.Chetlain@va.gov

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

813-972-2000 x 4914

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Warehouse 13000 Bruce B. Downs Blvd.

Tampa, FL 33612 4798

USA

Page 1 of Page 1 of

B.4 STATEMENT OF NEED

1. GENERAL: The James A. Haley Veterans’ Hospital (JAHVH), Pathology and Laboratory Medicine Service, Molecular Diagnostics Department, is seeking Real-Time (RT) polymerase chain reaction (PCR) analyzer and reagents for cancer and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection. The need is for a Cost Per Test (CPT or Reagent Rental) solution to perform these tests: Kirsten rat sarcoma viral oncogene homolog (KRAS), B-Raf (BRAF), Estimated glomerular filtration rate (EGFR), Microsatellite instability (MSI), Neuroblastoma RAS viral (v-ras) Oncogene homolog (NRAS3), GeneFusion and SARS-CoV-2 testing.

2. SCOPE: The contractor must maintain the JAHVH laboratory instrument system for RT PCR cancer detection and SARS-CoV-2 testing. The instrument based on a molecular diagnostic testing platform featuring samples-in and results-out capability necessary to operate the contractor’s equipment. The scope includes all hardware and software upgrades, personnel training, and equipment maintenance required to fulfill the test requirements. The CPT price to include costs of equipment reagent rental, RT PCR cancer detection testing, all necessary maintenance, and service to keep the equipment in good operating condition, operational hardware and software upgrades, user training for government personnel, yearly preventive maintenance per manufacturer’s recommendations, complete service support, including all shipping and handling delivery costs. The contractor is required to provide decontamination, de-installation, removal, and turn-in of hard-drive to VA IT, return packaging, and shipment of equipment at no additional charge at contract completion.

3. EQUIPMENT SPECIFICATIONS: Below are the salient characteristics of RT PCR instrument capable of performing RT PCR testing for KRAS, BRAF, EGFR, MSI, NRAS3, GeneFusion on patient tissue and plasma specimens for cancer detection and SARS-CoV-2 from patient nasopharyngeal swab specimens including specific functionality and performance-based requirements of the system.

Salient Characteristics of the Laboratory Instrument:

· The Molecular instrument must be a fully automated system, with random access technologies on integrated platform that improves workflow processes in the laboratory.

· Must be able to reduce turnaround times, minimize individual analyzer and maximize efficiency.

· The analyzer to provide a high throughput with sample-to-answer within 3 hours maximum.

· The contractor shall provide all upgrades to the equipment hardware and operating system software, all-inclusive with established cost.

· The equipment must be able to run individual samples without the need for batching or running external daily Quality Control (QC), provide for reagents room temperature storage conditions, and run different assays simultaneously.

· Configuration includes on-board QC program capable of printing/displaying all internal QC/calibrations to facilitate the detection of outliers or failures.

· The instrument provides closed-cartridge technology which dramatically reduces cross-contamination issues.

· Performs bar-coded data entry.

· Transmits data through a network connection.

· Prints, displays all internal QC calibration.

· Fast, easy setup and walkaway operation.

· Offers contamination-controlled design.

· Between minimum of 2 to maximum of 5 minutes hands-on time.

· Instrument Operator’s and Service manuals provided as well as procedures in accordance with the Clinical and Laboratory Standards Institute (CLSI) format.

· Physical space dimensions of benchtop instrument: NTE 28” x 36” x 30” (W x D x H).

· All work shall be performed in accordance with the guidelines established by Federal, State and local ordinances, FDA manufacturer’s guidelines, and with all terms, conditions, provisions and specifications provide herein.

Salient characteristics of the Laboratory Assays needed:

· The contractor provides the reagents, controls and consumables necessary to perform these tests: KRAS, BRAF, EGFR, MSI, NRAS3, GeneFusion and SARS-CoV-2.

· Self-contained, single-use disposable test cartridges.

· All reagents integrated in a single cartridge.

· No front-end sample preparation.

· On demand access.

· Room temperature reagents.

· Detection of up to 52 relevant mutations in one cartridge.

· For KRAS mutation testing, must be able to detect at least 21 mutations in KRAS exon 2, 3, and 4.

· For BRAF mutation testing, must be able to detect at least 7 mutations in BRAF exon 15.

· For EGFR mutation testing, must be able to detect at least 51 mutations in EGFR exon 18, 19, 20, and 21.

· For NRAS3 mutation testing, must be able to detect at least 23 mutations in NRAS exon 2, 3, 4, and BRAF exon 15.

· For MSI mutation testing, must be able to detect at least 7 MSI loci.

· For GeneFusion assay testing, must be able to detect Anaplastic lymphoma kinase gene (ALK), c-ros oncogene 1 gene (ROS1), Rearranged during transfection (RET), Neurotrophic Tropomyosin-Related Kinase (NTRK) 1,2,3 rearrangements and MET exon 14 skipping.

· For tissue testing, should only require 1 slice of Formalin-Fixed Paraffin-Embedded (FFPE) tissue.

· For plasma testing, should only require 1 ml of plasma for testing.

· The SARS-CoV-2 RT PCR testing is for qualitative detection of Ribonucleic acid (RNA) from the SARS-CoV-2 in patient nasopharyngeal swab specimens.

· Ability to add new tests. If any new tests are added as requested, the contractor shall provide reagents for the validation and implementation of new assays at no additional cost.

4. GENERAL REQUIREMENTS: The contractor is required to maintain the equipment. The contractor will provide all operational upgrades to the equipment hardware and operating system software that materially affects the equipment’s performance, at no 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 86-degrees F (15 and 30 degrees Celsius). All models shall perform satisfactorily at any relative laboratory humidity between 10 and 70%. An electronic operator’s manual must be included with each model supplied.

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

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

5. 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. The contractor’s preventive maintenance will provide regular, scheduled maintenance to ensure the equipment’s continued reliable operation. These preventative maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment

6. TRAINING: The contractor shall provide supplemental operating training to the government assigned key-operator personnel, at no additional charge to the government, upon installing an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

7. SERVICE: Emergency repairs shall be performed within 48 hours after notification that the equipment is inoperative. The scheduled maintenance and service shall be repaired by a qualified engineer with notice to the Contracting Officer Representative (COR). James A Haley's regular business hours are (6:00 a.m. - 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 arrange to enable his maintenance representative to receive such notification. The contractor will provide all parts and labor needed to repair the malfunction. The contractor will bear the travel, per diem, and other expenses associated with the repair. At no charge to the Government during this period, all services will be performed 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.

8. ORDERING/DELIVERY: The contractor shall deliver reagents, supplies, disposables within seven (7) days of order placement, FOB destination shipping cost included. The contractor will ensure 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 The Joint Commission (TJC).

9. WARRANTY OF EQUIPMENT: The Government requirement for standard manufacturer industry warranty term shall remain active. The government does not accept the extended warranty, which requires advance payment.

SECTION C - CONTRACT CLAUSES

C.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2020)

(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 2020) (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 (JUN 2020), 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 (JUN 2020) (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 (JUN 2020) (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. (JUN 2020) (31 U.S.C. 6101 note).

[X] (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 (MAR 2020) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-3.

[X] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-4.

[] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) 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 (JUN 2020) (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 (JUN 2020) of 52.219–9.

[] (v) Alternate IV (JUN 2020) of 52.219–9.

[] (18)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[] (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (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 (MAR 2020) (15 U.S.C. 657f).

[X] (22)(i) 52.219-28, Post Award Small Business Program Rerepresentation (NOV 2020) (15 U.S.C 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219-28.

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (MAR 2020) (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 (MAR 2020) (15 U.S.C. 637(m)).

[] (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

[] (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)) [] (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[X] (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126).

[X] (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

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

[X] (31)(i) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

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

[X] (32)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

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

[X] (33) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X] (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (35)(i) 52.222-50, Combating Trafficking in Persons (OCT 2020) (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).

[] (36) 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.)

[] (37)(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.)

[] (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (40)(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.

[] (41)(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.

[] (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

[] (43)(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] (44) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

[] (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).

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

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

[] (48) 52.225-1, Buy American—Supplies (MAY 2014) (41 U.S.C. chapter 83).

[] (49)(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] (50) 52.225–5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (51) 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).

[] (52) 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).

[] (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[] (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[X] (55) 52.229–12, Tax on Certain Foreign Procurements (JUN 2020).

[] (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[] (57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[X] (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

[] (59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

[] (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

[] (63)(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) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (3) 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).

[] (4) 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).

[] (5) 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).

[] (6) 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).

[] (7) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020).

[] (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

[] (9) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (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, as defined in FAR 2.101, on the date of award of this contract, 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 (JUN 2020) (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 2020) (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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219–8 in lower tier subcontracts that offer subcontracting opportunities.

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

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

(viii) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(ix) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(x) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xi) 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.

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

(xiii)(A) 52.222-50,…