36C24822R0059.pdf

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Attached to: 6640--Molecular Diagnostics Analyzer Reagent Rental Federal contract opportunity
Solicitation number: 36C24822R0059
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 8

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36C24822R0059 Amendment 0001.pdf	PDF	Apr 22, 2022
Attachment D.1 Security.pdf	PDF	Apr 6, 2022

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PAGE 1 OF1. 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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C24822R0059 04-06-2022

Camille Alderman 813-972-2000 x3133 06-24-2022

10:00 EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 525 Tampa FL 33637

334516

1000 Employees

N/A

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

See B.2 Price/cost schedule for items required. Instructions and Evaluation criteria under Section E of this solicitation

Any questions must be emailed to Camille.Alderman@va.gov by Friday 06/17/2022. Questions must be in bulleted format.

Base 08/01/2022 - 07/31/2023 Option Year One 08/01/2023 - 07/31/2024 Option Year Two 08/01/2024 - 07/31/2025 Option Year Three 08/01/2025 - 07/31/2026 Option Year Four 08/01/2026 - 07/31/2027

$0.00 See CONTINUATION Page

X X

36C24822R0059

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

STATEMENT OF NEED

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (AUG 2020)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

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

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...51

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.8 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.9 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.10 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

C.14 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: Attachment D.1 Security Exhibit D.2 SUB-CONTRACTING MODEL PLAN

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.3 52.216-1 TYPE OF CONTRACT (APR 1984)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

E.6 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

E.9 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

ITEMS

E.10 ADDENDUM TO FAR 52.212-2 EVALUATION—COMMERCIAL ITEMS

(OCT 2014)

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:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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:

AMENDMENT NO DATE

STATEMENT OF NEED

1. GENERAL: The Contractor shall provide Cost-Per-Test (CPT) Food and Drug Administration (FDA)-approved, fully automated, and integrated molecular diagnostic testing systems capable of performing patient testing for Hepatitis C Virus (HCV), Human Immunodeficiency Virus Type 1 (HIV-1), and Hepatitis B Virus (HBV) Viral Loads, Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG), Human Papillomavirus (HPV) Genotyping, and SARS-CoV-2 utilizing FDA-approved and FDA Emergency Use Authorization (EUA)-approved reagents, calibrators, controls, supplies and consumables for the James A. Haley Veterans’ Hospital (JAHVH), Pathology & Laboratory Medicine Service, Molecular Diagnostics Department, Tampa, Florida.

2. BACKGROUND: The JAHVH Molecular Diagnostics Department of the Pathology & Laboratory Medicine Service has a requirement for an FDA-approved, reliable, user-friendly, high-throughput automated molecular diagnostic systems including vendor provided equipment, reagents, calibrators, controls, supplies, and consumables for Molecular testing for our patient population.

3. PURPOSE: The ability to perform Molecular Diagnostics testing using FDA-approved automated analyzer systems, reagents, calibrators, controls, supplies and consumables, in order to provide our VA patient population.

4. SCOPE: James A. Haley is requesting contractors provide new equipment that meets all the minimum physical, functional and performance features of the listed salient characteristics in this section. These salient characteristics are essential to the technical requirements to meet the needs of the government.

5. EQUIPMENT: Contractor shall provide FDA-approved, new, fully automated, and integrated analyzer testing systems, printers, computers, Uninterruptable Power Supplies (UPS) for all analyzers, and accessories required for equipment usage.

Below are the salient characteristics of the Molecular Diagnostics FDA-approved instrument(s) and reagents capable of performing HCV, HIV-1, and HBV Viral loads, SARS-CoV-2 detection from nasopharyngeal swab samples, Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) from urine, vaginal, endocervical, rectal and oral samples, and the detection of human papillomavirus (HPV) Genotypes in patient specimens with specific functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications for the testing systems and assay requirements:

a. General instrument characteristics include ability to run FDA-approved patient testing for HCV, HIV-1, HBV Viral Loads, Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG), Human papillomavirus (HPV) Genotyping, and FDA EUA-approved SARS-CoV-2 detection from nasopharyngeal swab samples on RT-PCR technology-based platforms.

See below our Molecular Diagnostic Annual Estimated Test Volumes:

Test Annual Estimated Test Volume

HCV Viral Load 5,000

HIV-1 Viral Load 6,000

HBV Viral Load 2,000

CT/NG Qualitative Testing 20,000

HPV Genotyping 5,000

SARS-CoV-2 Qualitative Testing 120,000

b. The CT/NG assay must be FDA-approved for testing on CDC recommended specimen types: male and female urine, clinician-collected vaginal, endocervical, rectal and oral swab specimens.

c. An Internal Control/Quantitation Standard (IC/QS) must be incorporated into each individual sample and carried through the sample preparation, testing and result phases of analysis for each assay.

d. The HPV assay must detect high-cancer-risk HPV Genotypes present in each test specimen.

e. The HCV, HIV-1, and HBV Viral Load assays must include a method for the elimination of PCR product carryover during analysis.

f. The HCV Viral Load assay must accurately detect and quantify the HCV genotypes 1 through 6 to provide accuracy in HCV viral load test results.

g. The HIV-1 quantitative nucleic acid test must detect HIV-1 variants for higher quantification accuracy.

h. The HIV-1 Viral Load test must have a minimum linear range of 20 copies/mL - 10,000,000 copies/mL for greater range assessment of patient treatment efficacy.

i. Positive and Negative Controls must be included for all tests.

j. The instrument systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste and improving efficiency and conserving Tech time.

k. The instrument systems must be fully enclosed automated systems with air lock doors and HEPA filtration providing confined extraction processing reducing aerosolization in order to eliminate contamination of testing.

l. Bar-coded sample entry capabilities.

m. The instrument systems must provide automated onboard storage and refrigeration system for ease of access and inventory maintenance of consumables and reagents improving efficiency and conserving Tech time.

n. All assays must utilize pre-calibrated reagents, requiring no user calibration for improved efficiency and conservation of Tech time.

o. No preparation, ready to use reagents that can be loaded directly onto the instrument and tracked by the analyzer for remaining test quantity and stability improving efficiency and conserving Tech time.

p. Overnight operation capabilities of analyzer systems from start of sample testing to finish

– requiring no Tech intervention.

q. The Contractor’s systems must process a minimum of 96 results in 3.5 hours for a total of 192 results in a 7 hour period per instrument for efficiency and conservation of Tech time.

r. The instrument systems must offer open channels for both IVD assays and high-volume laboratory developed tests (LDTs).

s. Third-party instrument systems are not acceptable for uniformity of service and support needs in keeping with improving efficiency and conserving Tech time as listed in m.

above and per throughput requirement as listed in q. above.

t. Contractor to provide all test kits, reagents, calibrators, controls, supplies, consumables, and Contractor assistance required for instrument and method validations.

u. The Contractor’s molecular media collection kits must deactivate SARS-CoV-2 virus for safer collection, transport and processing of media post patient nasal and nasopharyngeal swab specimen collection. The instrument shall employ Uni- and bi-directional LIS interface to simplify order and result handling.

v. Additional testing may be added in support of patient care needs as determined by care providers.

w. Computer systems (CPUs, Monitors, Keyboards, Printers), and UPS’s provided for all instruments throughout contract period.

x. Our laboratory working space dimensions in inches (“) are listed below. Contractor to offer analyzer system(s) that fit within one or both separated spaces below which includes working space:

120” Width x 90” Height x 96” Depth

135” Width x 90” Height x 60” Depth.

y. Electrical Characteristics: Voltage: 110 – 120 and 220 – 240 VAC; Frequency: 50/60 Hz; Delayed-action fuse: 115 VAC: 6.3 A, 230 VAC: 3.15 A; Power interruption: </= 10 ms [Uninterruptable Power Supply (UPS) required for each analyzer].

6. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Must provide the following functional and performance capabilities to ensure new equipment is utilized and maintained according to requirements of the system:

a. Preventive Maintenance shall be performed per manufacturer’s guidelines.

b. Instrument service to be provided 24 hours per day, 7 days per week including holidays.

Expected response to service call time from initial call to Contractor to service engineer arriving on site should be no more than 24 hours including weekdays, weekends, and holidays.

c. 24/7 Technical Support Hotline must be available for in-house troubleshooting.

The Cost per-test includes costs covering (a) new FDA-approved instrument systems, (b) equipment use, computers, printers and accessories including Uninterruptable Power Supplies for all instruments (UPS) [reagent rental], (c) Software, (d) all aspects of computer interfacing for all analyzer systems, (e) reagents, calibrators and controls offered by vendor, (f) all necessary supplies and consumables, (g) all necessary service, maintenance and parts to keep the equipment in good operating condition to fulfill the test requirements and produce high quality patient results, (h) operational hardware and software upgrades, (i) user training for government personnel, and (j) upon expiration of order(s) and/or termination and/or replacement of equipment, will provide equipment decontamination and return packing and shipping at no additional charge. 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 new analyzers or testing systems, parts and 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.

Discontinued or refurbished analyzers or testing system models are not acceptable.

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 laboratory relative humidity of 10 to 70%. 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 decontaminate and remove the equipment and turn in any hard drives containing VA sensitive information to VA IT Department. The contractor will disconnect the equipment and will be responsible for all decontamination, packing, shipping, and charges required to remove the equipment within ten business days.

With all new equipment, 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's Representative (COR) for on-site orientation and training for 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. Off-site training to be provided at no additional cost to the VA, if available, for 2 designated personnel initially and 2 additional training slots per year for each subsequent contract year.

9. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE:

a. 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 cost 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).

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, parts and shipping) 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 VA Hospital, Pathology & Laboratory Medicine Service is open 24 hours a day, 7 days a week including 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, labor and shipping 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. TECHINCAL UPGRADES: 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 to be delivered within 30 days after Receipt of Order (ARO) processing and placement. Any required initial equipment staging, setup, installation, correlation, and transition, to be completed within six (6) months ARO processing and placement. All reagents, consumables, supplies, to be delivered within ten (10) days ARO processing and placement.

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

The quantities listed in the below Price Schedule below are estimates only and are not to be considered a minimum or maximum. Order limitations minimum and maximum are listed under C.2 52.216-19 of this solicitation. A delivery order shall be issued at the start of each performance period. The Government is not obligated to purchase any specified amount of supplies under this contract, but will be obligated to make payment for all supplies requested and received in the quantities requested. The Government does not guarantee or imply that any fixed number of orders for supplies will be placed under the resultant contract. All orders will be placed by a warranted Contracting Officer in issuance of a delivery order. Drop ship schedule will be communicated by designated Laboratory point of contact.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12.00 MO ______________

Molecular Diagnostics Reagent Rental Lease includes all instruments, equipment, service, maintenance, training, shipping and handling required to produce high quality patient results and keep equipment in optimum condition. All line items in accordance with the below statement of need.

Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): To be determined

0002 23.00 KT ______________

HPV AMP/DET ASSAY KIT 240T US-IVD

MANUFACTURER PART NUMBER (MPN): 5235880190

0003 91.00 KT ______________

CT/NG AMP/DET ASSAY KIT 240T US-IVD

MANUFACTURER PART NUMBER (MPN): 7102569190

0004 40.00 KT ______________

HCV VIRAL LOAD ASSAY KIT 192T IVD

Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 9040765190

0005 30.00 KT ______________

HIV-1 VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040803190

0006 5.00 KT ______________

HBV VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040820190

0007 230.00 KT ______________

SARS-COV-2 MOLECULAR FDA-EAU ASSAY KIT 480T

MANUFACTURER PART NUMBER (MPN): 9343733190

0008 62.00 BX ______________

Tip CORE TIPS with Filter, 1mL Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 4639642001

0009 100.00 KT ______________ ________________

PCR URINE 100 PKT IVD

MANUFACTURER PART NUMBER (MPN): 5170486190

0010 23.00 EA ______________

Extraction Plate 1.6mL Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232716001

0011 23.00 EA ______________

AD-plate 0.3mL Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232724001

0012 14.00 EA ______________

Reagent reservoir 50mL Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232732001

0013 12.00 EA ______________

Reagent reservoir 200mL Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232759001

0014 114.00 KT ______________

SYS SAMPLE PREP 240T IVD

MANUFACTURER PART NUMBER (MPN): 5235782190

0015 37.00 KT ______________

SYS LIQ CYT PREP 240T IVD

MANUFACTURER PART NUMBER (MPN): 5235812190

0016 114.00 EA ______________

SYS WASH BUFFER 240T IVD

MANUFACTURER PART NUMBER (MPN): 5235863190

0017 91.00 KT ______________

SYS CTL DIL 10 SETS IVD

MANUFACTURER PART NUMBER (MPN): 5235847190

0018 92.00 EA ______________

Processing Plate Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5534917001

0019 184.00 EA ______________

Pipette Tips Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5534925001

0020 46.00 EA ______________

Amplification Plate Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5534941001

0021 488.00 KT ______________

WASH IVD

MANUFACTURER PART NUMBER (MPN): 6997503190

0022 124.00 KT ______________

SPEC DIL REAGENT IVD

Contract Period: Base

POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 6997511190

0023 122.00 KT ______________

LYS REAGENT IVD

MANUFACTURER PART NUMBER (MPN): 6997538190

0024 293.00 KT ______________

MGP IVD

MANUFACTURER PART NUMBER (MPN): 6997546190

0025 1,410.00 EA ______________

PCR MEDIA DUAL SWB 100 Package IVD Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 7958021190

0026 23.00 KT ______________

HPV CONTROLS 10 SETS IVD

Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory

PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5235855190

0027 91.00 KT ______________

CT/NG CTL 10 SETS IVD

MANUFACTURER PART NUMBER (MPN): 5235928190

0028 86.00 KT ______________

HBV/HCV/HIV RMC IVD

MANUFACTURER PART NUMBER (MPN): 9040773190

0029 43.00 KT ______________

NHP NEG RMC IVD

MANUFACTURER PART NUMBER (MPN): 9051554190

0030 81.00 KT ______________

Buffer Negative Control Kit Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 7002238190

0031 81.00 KT ______________

SARS-COV-2 Control Kit Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 9175440190

0032 20.00 EA ______________

Solid Waste Bags Contract Period: Base POP Begin: 08-01-2022 POP End: 07-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 8030073001

1001 12.00 MO ______________

Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): To be determined

1002 23.00 KT ______________

HPV AMP/DET ASSAY KIT 240T US-IVD

MANUFACTURER PART NUMBER (MPN): 5235880190

1003 91.00 KT ______________

CT/NG AMP/DET ASSAY KIT 240T US-IVD

MANUFACTURER PART NUMBER (MPN): 7102569190

1004 40.00 KT ______________

HCV VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040765190

1005 30.00 KT ______________

HIV-1 VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040803190

1006 5.00 KT ______________

HBV VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040820190

1007 230.00 KT ______________

SARS-COV-2 MOLECULAR FDA-EAU ASSAY KIT 480T

Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024

PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 9343733190

1008 62.00 BX ______________

Tip CORE TIPS with Filter, 1mL Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 4639642001

1009 100.00 KT ______________

PCR URINE 100 PKT IVD

MANUFACTURER PART NUMBER (MPN): 5170486190

1010 23.00 EA ______________

Extraction Plate 1.6mL Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232716001

1011 23.00 EA ______________

AD-plate 0.3mL Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232724001

1012 14.00 EA ______________ ________________

Reagent reservoir 50mL Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232732001

1013 12.00 EA ______________

Reagent reservoir 200mL Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232759001

1014 114.00 KT ______________

SYS SAMPLE PREP 240T IVD

MANUFACTURER PART NUMBER (MPN): 5235782190

1015 37.00 KT ______________

SYS LIQ CYT PREP 240T IVD

MANUFACTURER PART NUMBER (MPN): 5235812190

1016 114.00 EA ______________

SYS WASH BUFFER 240T IVD

Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5235863190

1017 91.00 KT ______________

SYS CTL DIL 10 SETS IVD

MANUFACTURER PART NUMBER (MPN): 5235847190

1018 92.00 EA ______________

Processing Plate Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5534917001

1019 184.00 EA ______________

Pipette Tips Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5534925001

1020 46.00 EA ______________

Amplification Plate Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

MANUFACTURER PART NUMBER (MPN): 5534941001

1021 488.00 KT ______________

WASH IVD

MANUFACTURER PART NUMBER (MPN): 6997503190

1022 124.00 KT ______________

SPEC DIL REAGENT IVD

MANUFACTURER PART NUMBER (MPN): 6997511190

1023 122.00 KT ______________

LYS REAGENT IVD

MANUFACTURER PART NUMBER (MPN): 6997538190

1024 293.00 KT ______________

MGP IVD

MANUFACTURER PART NUMBER (MPN): 6997546190

1025 1,410.00 EA ______________

PCR MEDIA DUAL SWB 100 Package IVD Contract Period: Option 1

POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 7958021190

1026 23.00 KT ______________

HPV CONTROLS 10 SETS IVD

MANUFACTURER PART NUMBER (MPN): 5235855190

1027 91.00 KT ______________

CT/NG CTL 10 SETS IVD

MANUFACTURER PART NUMBER (MPN): 5235928190

1028 86.00 KT ______________

HBV/HCV/HIV RMC IVD

MANUFACTURER PART NUMBER (MPN): 9040773190

1029 43.00 KT ______________

NHP NEG RMC IVD

Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory and Supplies

MANUFACTURER PART NUMBER (MPN): 9051554190

1030 81.00 KT ______________

Buffer Negative Control Kit Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 7002238190

1031 81.00 KT ______________

SARS-COV-2 Control Kit Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 9175440190

1032 20.00 EA ______________

Solid Waste Bags Contract Period: Option 1 POP Begin: 08-01-2023 POP End: 07-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 8030073001

2001 12.00 MO ______________

Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

MANUFACTURER PART NUMBER (MPN): To be determined

2002 23.00 KT ______________

HPV AMP/DET ASSAY KIT 240T US-IVD

Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5235880190

2003 91.00 KT ______________

CT/NG AMP/DET ASSAY KIT 240T US-IVD

MANUFACTURER PART NUMBER (MPN): 7102569190

2004 40.00 KT ______________

HCV VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040765190

2005 30.00 KT ______________

HIV-1 VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040803190

2006 5.00 KT ______________

HBV VIRAL LOAD ASSAY KIT 192T IVD

MANUFACTURER PART NUMBER (MPN): 9040820190

2007 230.00 KT ______________

SARS-COV-2 MOLECULAR FDA-EAU ASSAY KIT 480T

MANUFACTURER PART NUMBER (MPN): 9343733190

2008 62.00 BX ______________

Tip CORE TIPS with Filter, 1mL Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 4639642001

2009 100.00 KT ______________

PCR URINE 100 PKT IVD

MANUFACTURER PART NUMBER (MPN): 5170486190

2010 23.00 EA ______________

Extraction Plate 1.6mL Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025

PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232716001

2011 23.00 EA ______________

AD-plate 0.3mL Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232724001

2012 14.00 EA ______________

Reagent reservoir 50mL Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232732001

2013 12.00 EA ______________

Reagent reservoir 200mL Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): 5232759001

2014 114.00 KT ______________

SYS SAMPLE PREP 240T IVD

Contract Period: Option 2 POP Begin: 08-01-2024 POP End: 07-31-2025 PRINCIPAL NAICS CODE:…

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