36C24824Q0012_1.pdf

36C24824Q0012

COMBINED SYNOPSIS/SOLICITATION RFQ 36C24824Q0012

General Information

Action Code: Combined Synopsis Solicitation

Document Type: RFQ

RFQ Number: 36C24824Q0012

Posted Date: 9/26/2023

Response Date: 10/05/2023 by 4:30PM EST

Classification Code: 6640

Set Aside: Full and Open

NAICS Code: 334516

Contracting Office Address

NCO 8

ATTN: Heidi Parrish 1601 SW Archer RD Gainesville, FL 32608

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with Part 13, as supplemented with additional information included in this notice. This procurement is being conducted under Subpart 13.5 Simplified Procedures for Certain Commercial items. This announcement constitutes the only solicitation for this action. Quotes are being requested, and a written solicitation will not be issued.

This solicitation is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-05 Effective September 7, 2023.

The Network Contracting Office 8-SAO East intends to award a firm fixed priced contract, providing for all supplies, materials, equipment, labor, supervision, management, and transportation, necessary to furnish Flow Cytometry Testing Cost Per Test in accordance with the attached Price Schedule.

Prospective offerors shall be a registered in the System for Award Management (SAM) at http://www.sam.gov to be considered for an award of a federal contract, and registration shall be complete and not missing elements such as representations and certifications.

VENDOR QUESTIONS: All questions regarding this RFQ must be in writing and may be sent by e‐mail to heidi.parrish@va.gov by 4:30 PM on 09-28-2023.

ANSWERS TO VENDOR QUESTIONS: Answers to vendor questions will be posted on SAM.gov by

NOON 09-29-2023.

You are reminded that representatives from your company SHALL NOT contact any North Florida/South Georgia Veterans Health System staff to discuss this RFQ during this RFQ process. All questions and concerns regarding this RFQ shall be directed to Heidi Parrish, the Contracting Officer.

QUOTE SUBMISSION: Offers are due on/or before 10/05/2023 by 4:30 PM Eastern. Quotes shall be sent by e‐mail “only” to the Contracting Officer (Heidi Parrish) at heidi.parrish@va.gov. The Government intends to award a Firm Fixed Priced (FFP) contract resulting from this RFQ.

Table of Contents

COMBINED SYNOPSIS/SOLICITATION RFQ 36C24824Q0010

SECTION B - CONTINUATION

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF NEED

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 24

C.3 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.4 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(OCT 2019)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 26

C.6 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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

E.4 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (NOV 2021)

E.5 52.227-17 RIGHTS IN DATA—SPECIAL WORKS (DEC 2007)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Heidi Parrish, Contracting Officer 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) North Florida/South Georgia VHS 1601 SW Archer Road Gainesville FL 32608-1197

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

[X] 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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

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

AMENDMENT NO DATE

B.2 STATEMENT OF NEED

1. INTENT

1.1 It is the intent of the Malcom Randall VA Healthcare System (MRVAHCS) to establish a Cost Per-Test (CPT) Agreement for an Automated Flow Cytometry System. It is the intent of the Government to award this contract to a single contractor for a flow cytometry system. The CPT shall Open Market. Contractor agrees to the following terms of the CPT exclusively with the MRVAHCS facility.

1.2 All products ordered under this agreement, are subject to the terms and conditions of the contract. This agreement does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the agreement by authorized individuals.

1.3 Prices and Terms: Malcom Randall VAHCS estimates the volume of tests performed as reflected in Section 4. Firm fixed pricing shall be based on the AVERAGE DAILY TEST VOLUME Per INSTRUMENT /ANALYZER. Pricing shall be based on the Cost per Test Result. The Government estimates the volumes listed in the test menu (#4 below) per facility but does not guarantee volumes as listed; they are ESTIMATES ONLY.

1.4 TERM OF AGREEMENT: The agreement shall be effective for up to five (5) years. This agreement is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this CPT may be canceled with thirty (30) days written notice to the Contractor by the CO. This CPT shall be reviewed annually. Malcom Randall VAMC intends to establish the base year of the agreement for the period of November 1st, 2023 through September 30th, 2024.

1.5 IDENTIFICATION: Orders issued shall be identified by Purchase Order Number and Contract Number.

1.6 ORDERING METHOD: Malcom Randall VAHCS may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1 The desired instrumentation/system shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

2.2 The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted.

These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control bottles. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals, lab manager and/or service chief.

2.3 Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the contractor’s equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the contractor shall deliver to the government site in the most expeditious manner possible without additional cost to the government, the necessary consumables in sufficient quantity as required to allow operation of the contractor’s equipment for one week (under normal government test load volume). If additional requests for emergency supply delivery are required by the government, they shall be honored by the contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

3. DEFINITIONS

3.1 Cost per Test (CPT) – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a test result,

(c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

3.2 Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation/system, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation/system and must meet all of technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment.

3.3 Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule).

HIPAA regulations require VHA to execute HIPAA-compliant BAAs with everyone that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

4. TEST MENU

Malcom Randall VAMC Laboratory Estimated Annual Volumes for Flow Cytometry

TEST PANELS

(Refer to Required Panel Tests in Section 5.1 J below)

LEUKEMIA/LYMPHOMA PANELS

Malcom Randall VA Test 10-01-2023 to 09-30-

Malcom Randall VA Test 10-01-2024 to 09-30-

Malcom Randall VA Test 10-01-2025 to 09-30-

Malcom Randall VA Test 10-01-2027 to 09-30-

Malcom Randall VA Test 10-01-2028 to 09-30-

Note: All quantities are estimated – an increase of 10% has been added to each option year to plan for anticipated increase in quantities. The Government estimates the volumes listed in the test menu per facility but does not guarantee volumes as listed; they are ESTIMATES ONLY.

5. GENERAL REQUIREMENTS

5.1 Operational Features - The instrumentation/system offered shall have the following:

A. The ability to efficiently and productively meet the operational demands of the clinical Laboratory.

B. A minimum of 10-color fluorescence with an additional 2 channels for light scatter properties

C. A fully load/walk-away continuous, random capability for automated lymphocyte enumeration or CD4/CD8 counts with no sample preparation required and minimal maintenance or analyzer start up. This should be available for 24/7 operation and run safely with minimal specialty training or experience required.

D. Temperature Control mechanism that can regulate internal temperature and humidity fluctuations.

E. Flexibility of running any 12x75 tubes including glass or plastic.

F. Capable of individually mixing each sample tube before being delivered to the system

G. FDA approved system and software; windows-based operating system

H. A single or dual laser with fixed optical alignment

I. Capability to start interpreting data while instrument is still sampling and acquiring data from other patient samples on board

J. The minimal capability of reporting the following tests:

7AAD CD23 CD79a

CD10 CD25 CD8

CD103 CD3 FMC7

CD117 CD30 Glycophorin‐A

CD11b CD33 HLA‐DR

CD11c CD34 IgG1 Mouse

CD123 CD36 IgG2a Mouse

CD13 CD38 KAPPA

CD138 CD4 LAMBDA

CD14 CD43 MPO

CD15 CD45 sIgA

CD16 CD5 sIgD

CD19 CD56 sIgG

CD1a CD57 sIgM

CD2 CD64 TCR‐ab

CD200 CD7 TCR‐gd

CD22 CD71 TDT

T/B‐CELL PANEL TESTS

CD45/CD4/CD8/CD3

CD45/CD4/CD56/CD19CD/3

LEUKEMIA/LYMPHOMA PANEL TESTS

K. Minimal daily maintenance such that the analyzer is not required to be down for more than 60 minutes per day (this is not to exclude longer times for periodic maintenance).

L. A stand-alone, automated/semi-automated sample preparation system capable of reagent addition, incubation, washing (if necessary) and fixative addition; or an integrated sample prep module, automated reagent monitoring and barcode scanning, continuous loading with pipeline sample processing, data analysis, bidirectional LIS connectivity and automated QC

5.2 Technical Features – The instrumentation/system must be approved by the Food and Drug Administration (FDA) and shall have the following:

A. Data Management System with:

1. An automatic and manual system compensation

2. A real time compensation, data analysis and gating

3. A fully digital electronics for linear, log, etc. for all collected parameters, with post-acquisition electronics

4. The ability to create custom test panels

5. Software for remote data analysis, manipulation and interpretation by technologists and Hematopathologists (optional).

6. A quality control package used for daily monitor of system performance and operator notification upon QC failure

B. Automated Sample Preparation and Management with:

1. Features that can verify and track barcode labeled specimens and tubes through the sample process.

2. Full bi-directional LIS connectivity and user-friendly interface.

3. Cap piercing probe and processes 80 or more tubes per hour.

4. Continuous processing – can load and unload carousels and samples without halting operation.

5. Closed-tube sampling; ability to run whole blood and body fluids.

6. Capacity to have full range of on-board reagents including antibodies, lysing reagent, flow-count, buffers and diluents.

6. Minimal sample carryover % for sample pipetting

7. Adjustable flow rates

8. An integrated sample prep module, automated reagent monitoring and barcode scanning, continuous loading with pipeline sample processing, data analysis, bidirectional LIS connectivity and automated QC; or

9. A fully load/walk-away continuous, random capability for automated lymphocyte enumeration or CD4/CD8 counts with no sample preparation required and minimal maintenance or analyzer start up. This should be available for 24/7 operation and run safely with minimal specialty training or experience required, and approved for use in the USA.

5.3 Hardware Features - The instrumentation/system shall have the following:

A. Uninterrupted Power Supply (UPS) to provide uninterruptible electrical power without electrical voltage fluctuation.

B. An efficient, simple use color printer that will use a single toner with no additional waste units and displays minimally two forms of patient identification on the test report.

C. Accurate barcode reading with less than 5% read failures.

D. A 24” Widescreen LCD Display.

5.5 Support Features

A. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

B. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

C. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the contract. This shall include training of both the technical staff and pathologists on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation/system placed Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel for 2 primary operators, shall include the cost of airfare, room and board for each participant.

In addition, the Contractor shall provide additional on-site training 6-12 months after test implementation, if requested.

All training shall be provided by the Contractor at no additional cost to the Government.

D. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on primary and back-up instrumentation/system (if available) and any incremental support equipment, e.g. water system, offered according to the following terms:

A technical assistance center must be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hours.

Equipment repair service must be provided during core business hours.

Business hours are defined as Monday-Friday, 7:30AM-4:00PM . Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the contractor and VA laboratory personnel.

Equipment repair response time shall be no more than 4 hours.

Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

o date and time notified o date and time of arrival o serial number, type and model number of equipment o time spent for repair, and o proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

During the term of the CPT, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement.

Each notification for an emergency repair service call shall be treated as a separate and new service call.

E. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the CPT; however, it does refer to significant changes in the hardware operational capability.

F. Ancillary support equipment - The Contractor shall provide, install and maintain , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the vendor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

G. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g. PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software.

H. Characterization of hazardous waste – The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) Waste ignitability (Reference 40CFR261.21) Waste corrosivity (Reference 40CFR261.22) Waste reactivity (Reference 40CFR261.23) Hazardous waste from non-specific sources (F-listed) (Reference

40CFR261.31)

Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

(Reference 40CFR261.33) I. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the CPT. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

K. Upon award of a CPT, the transition period for the awarded CPT to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

L. Offerors shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded CPT including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the contractor to confirm to the transition period shall be considered as sufficient cause to terminate CPT for cause under the Termination for Cause clause of the CPT.

M. At the end of 90 days from award of the CPT, the awarded contractor shall have full and sole responsibility for services under the awarded CPT.

6. Standard and Quality of Performance - This paragraph establishes a standard of performance that shall be met before any equipment listed on the delivery order [or CPT] is accepted by the government. This also includes replacement, substitute equipment and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the contractor’s technical specification or as quoted in any CPT at an effectiveness level of 90% or more.

In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR.52.212-4 entitled “Termination for cause.” (The contractor shall receive revenue for tests reported during the 90-day acceptance period.)

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 equipment in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the contractor’s designated representative at the prearranged contact point until the system or equipment 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 shall 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.

During the term of the CPT, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement.

7. Government’s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user will maintain appropriate records to satisfy the requirements of this paragraph and will 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

8. Ownership of Equipment: Title to the equipment shall remain with the contractor. All accessories (unused consumables, etc) 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, shall remove the equipment. The contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

The vendor/contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any vendor/contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

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

All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the CPT or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per

6500.1 requirements. This must be completed within 30 days of termination or completion of the CPT or disposal or return of the IT equipment, whichever is earlier.

Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

a. Vendor must accept the system without the drive;

b. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

c. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

a. The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

b. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation.

Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or CPT.

c. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed.

The ISO needs to maintain the documentation.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

400.00 EA __________________ __________________

LEUKEMIA/LYMPHOMA PANELS Flow Cytometry testing- estimates based on last 12 months testing but will vary as patient needs.

Invoicing based on actual test ordered and performed.

Contract Period: Base POP Begin: 10-15-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

440.00 EA __________________ __________________

based on last 12 months testing but will vary as patient needs.

Invoicing based on actual test ordered and performed.

Contract Period: Option 1 POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

484.00 EA __________________ __________________

based on last 12 months testing but will vary as patient needs.

Invoicing based on actual test ordered and performed.

Contract Period: Option 2 POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

532.00 EA __________________ __________________

based on last 12 months testing but will vary as patient needs.

Invoicing based on actual test ordered and performed.

Contract Period: Option 3 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

585.00 EA __________________ __________________

based on last 12 months testing but will vary as patient needs.

Invoicing based on actual test ordered and performed.

Contract Period: Option 4 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

GRAND TOTAL __________________

B.4 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY DELIVERY DATE

0001 SHIP TO: Department of Veterans Affairs North Florida/South Georgia VHS 1601 SW Archer Road Gainesville, FL 32608 1197

USA

400.00 10-01-2023

1001 SHIP TO: Department of Veterans Affairs North Florida/South Georgia VHS 1601 SW Archer Road

440.00 10-01-2024

2001 SHIP TO: Department of Veterans Affairs North Florida/South Georgia VHS 1601 SW Archer Road

484.00 10-01-2025

3001 SHIP TO: Department of Veterans Affairs North Florida/South Georgia VHS 1601 SW Archer Road

532.00 10-01-2026

4001 SHIP TO: Department of Veterans Affairs North Florida/South Georgia VHS 1601 SW Archer Road

585.00 10-01-2027

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause…