36C24821Q0333 0002.docx

36C24821Q0333 0002

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 02-09-2021 None 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Suite 525 8875 Hidden River Pkwy Suite 525 Tampa FL 33637 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Suite 525 8875 Hidden River Pkwy Tampa FL 33637 To all Offerors/Bidders

36C24821Q0333 01-25-2021

X x x ** HOUR & DATE for Receipt of Offers is EXTENDED to: TUESDAY FEBRUARY 16TH, 2021, 4PM EST See CONTINUATION Page X The purpose of this amendment is to provide a B.4 Final Statement of need, updated B.2 Price/Cost Schedule, Attachment D.2 LOS Certification document and extend the due date for quotes. See below details of this amendment:

1. The COVID SARS testing is removed from the Statement of need. Vendors please see below B.4 Final Statement of need.

2. Line items 0008, 1008, 2008, 3008, 4008 were removed. Vendors complete and submit the below B.2 Price/Cost Schedule.

3. Attachment D.2 Limitations on Subcontracting. Vendors to complete in accordance with Paragraph CFR 13 C.F.R 125.6, date, sign, and submit with your quote.

4. Questions in response to this solicitation may be emailed to Camille.Alderman@va.gov NLT 02/11/2021 4 PM EST.

Submit your questions in bulleted format, include statement of need paragraph #, header, that question applies too.

Answers to all questions will be posted via amendment to solicitation no later than 02/12/2021.

5. Quote due date is extended from 02/10/2021 to 02/16/2021 @ 4PM EST to allow vendors additional time to prepare quote.

Camille Alderman Contracting Officer

CONTINUATION PAGE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment rental, 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.

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

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment rental, 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

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment rental, 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

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment rental, 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

One Real-Time (RT) Polymerase Chain Reaction (PCR) System Cost-Per-Test (CPT) to include equipment rental, 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

GRAND TOTAL

B.4 FINAL 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 lease capable of cancer detection. The need is for a cost per test (CPT), 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), and GeneFusion testing.

2. SCOPE: The scope CPT supply solution shall include cost of equipment lease, reagents, controls and consumables necessary for RT PCR cancer detection testing, all 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, all shipping and handling delivery costs. The contractor is required to provide decontamination, de-installation, removal, and turn-in of hard-drive to JAHVH information technology (IT) staff, return packaging, and shipment of equipment at no additional charge at contract completion.

3. EQUIPMENT SPECIFICATIONS: Contractor shall provide one (1) molecular analyzer instrument. The instrument is based on a molecular diagnostic testing platform featuring samples-in and results-out capability necessary to operate the contractor’s equipment. The instrument must be capable of performing RT PCR testing for KRAS, BRAF, EGFR, MSI, NRAS3, and GeneFusion on patient tissue and plasma specimens for cancer detection including specific functionality and performance-based requirements of the system. Contractor’s RT PCR instrument must meet or exceed the below salient characteristics:

· 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.

· System must fit within general physical space dimensions of benchtop instrument: NTE 28” x 36” x 30” (W x D x H).

4. TEST ASSAY SPECIFICATIONS: The contractor shall provide the reagents, controls and consumables necessary to perform these tests: KRAS, BRAF, EGFR, MSI, NRAS3, and GeneFusion. The cost per test solution allows for the ability to add new test assays. 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. Test assays must meet or exceed the below salient characteristics:

· 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.

5. GENERAL REQUIREMENTS: The contractor is required to maintain the equipment. 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.

Reagents Delivery terms, Quality of Reagents, Supplies and Consumables: The VA shall require the delivery of reagents, supplies and consumables for all services required under this contract. The contractor shall deliver reagents, supplies and consumables, shipping and handling costs included, from monthly call orders placed by JAHVH representative. The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce high-quality, accurate patient results. The FDA-approved reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC).

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 Representative 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.

6. MAINTENANCE: The contractor shall provide maintenance (includes all 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

7. 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.

8. 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. Any 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 contract period of performance.

The contractor shall provide a malfunction incident report to the government lab point of contact 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.

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.

10. ORDERING/DELIVERY: All equipment to be delivered within thirty (30) calendar days. The contractor shall deliver reagents, supplies, disposables within 7 days of order placement, FOB destination shipping cost included.

11. PLACE OF PERFORMANCE: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612.

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: Attachment D.2 LOS Solicitation Certification.

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