36C25921Q0426_1.docx

36C25921Q0426

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

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

ARE

ARE NOT ATTACHED.

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

ARE

ARE NOT ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C259-21-AP-0224

36C25921Q0426 05-10-2021 Ian Boettcher 303-712-5722 06-10-2021 12:30pm

MDT

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 X 334516 1000 Employees N/A X 36C635 Department of Veterans Affairs Oklahoma City VA Health Care System Attn: Lab 921 NE 13th Street Oklahoma City OK 73104 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

Submitted Electronically Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Infectious Disease Cost Per Reportable Result for the Oklahoma City VA Medical Center Period of Performance is July 1, 2021 through June 30, 2026 With the following ordering periods:

Ordering Period 1* - July 1, 2021 through January 31, 2022 Ordering Period 2 - February 1, 2022 through January 31, 2023 Ordering Period 3 - February 1, 2023 through January 31, 2024 Ordering Period 4 - February 1, 2024 through January 31, 2025 Ordering Period 5 - February 1, 2025 through January 31, 2026 2021 through January 31, 2022 Ordering Period 6* - February 1, 2026 through June 30, 2022 *Shortened Ordering Period Each ordering period will be funded by its own Call Order and PO number for invoicing.

See CONTINUATION Page X X Ian Boettcher

VA-VHA-2020-87BD5747

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

B.1.1. Contract Administration: All contract administration matters will be handled by the following individuals:

B.1.1.2. GOVERNMENT: Ian Boettcher, Contracting Officer Department of Veterans Affairs Rocky Mountain Network NCO 19 Contracting 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Telephone: 303-712-5722

FAX: 303-712-5800

E-mail: Ian.Boettcher@va.gov

B.1.2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

B.1.3. GOVERNMENT INVOICE ADDRESS: Invoices shall be submitted in arrears:

c. Other [X] MONTHLY IN ARREARS B.1.4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically to the VA Financial Services Center for payment processing, free of charge. For any questions about the e-invoicing program, please contact the FSC at the phone number or email address listed below:

1. TUNGSTEN e-Invoice Setup Information: (877) 752-0900

1. TUNGSTEN e-Invoice email: USClientServices@ob10.com

1. FSC e-Invoice Contact Information: (877) 353-9791

1. FSC e-invoice email: vafsccshd@va.gov

1. The following two codes will be required when creating a vendor profile in TUNGSTEN:

· TUNGSTEN Buyer Number AAA544240062

· Promo Code: VAPC7Y18

B.1.5. DUNS NUMBER: Please provide the Dun and Bradstreet Number assigned to your firm in the space provided: _____________________________

B.1.6. TAX IDENTIFICATION NUMBER: Please provide the tax identification number to be utilized for this contract: _____________________________ B.1.7. PERIOD OF PERFORMANCE: Services required herein shall be for the following time period: July 1, 2021 through June 30, 2026 Ordering Period 1 - 7/1/21 – 1/31/22 (Shortened POP) Ordering Period 2 - 2/1/21 – 10/31/23 Ordering Period 3 - 2/1/23 – 10/31/24 Ordering Period 4 - 2/1/24 – 10/31/25 Ordering Period 5 - 2/1/25 – 10/31/26 36C25921Q0426 Ordering Period 6 - 2/1/26 – 6/30/26 (Shortened POP) Page 1 of Page 1 of

B.2 STATEMENT OF WORK – Infectious Disease CPRR

1) SCOPE:

Contractor shall provide all analyzers, additional equipment, reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of its' contractor owned analyzers and peripherals for the generation of Infectious Disease (ID) testing for Oklahoma City VA Health Care System (OKCVAHCS) cost per reportable result (CPRR) services. A services component shall also be included in the contract, to provide maintenance, repairs, upgrades, training and a Quality Control program. Equipment, supplies, and services shall be required for a base year period with four one-year options for renewal. Equipment, supplies and services shall be provided at:

a) Oklahoma City VA Medical Center (OKCVAMC), 921 NE 13th Street, Oklahoma City, Oklahoma 73104

2) DEFINITIONS:

Cost Per reportable Result (CPRR): Contractors are required to provide a price for each patient test that can be performed on its equipment. The per reportable patient test price shall include costs covering (a) equipment use, (b) all reagents, calibrators, controls, linearity samples, supplies, consumable/disposable items, parts, accessories, Uninterruptable Power Supply, Printer and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs), (d) training for Government personnel, and (e) cost of shipping and handling of all reagents, calibrators, controls, supplies, consumable/disposable items, parts, accessories, uninterruptible power supply with line conditioner and all other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of test results. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

3) GENERAL REQUIREMENTS:

a) Offered models of clinical laboratory ID testing instruments shall be capable of producing accurate and reproducible assays on Plasma and/or Serum specimens by established in vitro diagnostic methods. Models shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

b) Offered equipment shall be new FDA approved equipment. Remanufactured and discontinued models will not be accepted.

c) The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market.

d) The models being offered shall be in current production. Current production shall mean that the clinical laboratory analyzer model is being manufactured as new equipment and is currently available from the offeror for CPRR. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

e) An operator’s manual shall be furnished with each instrument supplied to VA and updates to manual shall be provided in a timely manner.

f) Editable electronic copy in CLSI (Clinical and Laboratory Standards Institute) format of operating procedures and related training and maintenance documents shall be furnished with each instrument supplied to the VA.

g) All proposed equipment must fit the existing space at the facility, without the need for renovation work. Fitting existing space shall include conforming to the current structural parameters of each lab, in each facility, in terms of delivery, installation and lab space. (I.e. equipment size, weight, packaged size for delivery, electrical/voltage).

h) The following FDA approved tests are required of the contractor’s analyzer and reagents:

a. Hepatitis C Virus Antibody

b. Hepatitis B Core IGM Antibody

c. Hepatitis Total B Core Antibody

d. Hepatitis A, IgM Antibody

e. Hepatitis A, IgG Antibody or Total HAV

f. Hepatitis B Surface Antigen

g. Hepatitis B Surface Antibody

h. HIV Ag/Ab combination, 4th Generation or later

i. Any confirmatory test that may be provided/required by the contractor to produce a reportable result.

i) The following FDA approved tests are preferred but not required of the contractor’s analyzer and reagents:

j. Rheumatoid Factor

k. Tacrolimus

j) Pricing: The CPRR shall include all costs for:

i. Use of equipment.

ii. All consumables, reagents, calibrators, controls, supplies, consumable/disposable items, parts, accessories and any other items required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result.

iii. All necessary maintenance to keep equipment in manufacturer's operating conditions, both preventive maintenance, and emergency repairs.

iv. Training for facility personnel operating equipment.

The awarded contractor is required to provide delivery, installation, set-up, validation, and method comparison, including all supplies provided by the vendor, and decontamination, packaging, and removal of equipment at completion of this agreement at no additional charge to the Government.

4) SYSTEM REQUIREMENTS

a) The instrument shall fit within a 4’ x 8’ area with a height of no more than 8’ with any doors open to their maximum height. Construction on/modification of the available space is not permitted at this time.

b) The instrument shall utilize 100V or 220V power.

c) The instrument shall perform satisfactorily at any laboratory temperature between 64- and 90-degrees Fahrenheit (18 and 32 Celsius) and relative humidity and altitude at the site of use.

d) The instrument shall have random access capability (if discrete testing is required) 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).

e) A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

f) Accuracy of the barcode reading must have less than a 1% failure rate

g) Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently

h) Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric

i) Prioritization of STAT testing is required

j) Minimal Daily, Monthly and Periodic Maintenance

k) Ability to store and transmit records (at least 24 hours of instrument throughput) in case of interface outage

l) On board reagent stability enough to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (4) months for reagents

m) No requirements for sample pre-treatment unless sample dilution is required for a result for a majority of testing. For some assays this in unavoidable due to the nature of the test, for example immunosuppressive drugs.

n) Automated specimen handling/loading system

o) Minimal reagent preparation

p) Capability to store at least 1000 patient results in database for immediate recall

q) Instrument must be approved by the Food and Drug Administration (FDA) and shall have the following:

i. Ability to monitor instrument performance.

ii. On Board reagent inventory system.

iii. Minimal carryover.

iv. Long calibration stability.

r) A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

s) An on-board monitor/screen that is easily readable.

t) A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

u) An uninterruptible power supply with line conditioner for each instrument provided.

v) Water supply system if required by analyzer, that meets the analyzer’s standards, I.e. Reagent Grade or CLSI special reagent grade water.

w) An auto sampling system

x) Accepts multiple tube size with the Primary being Lithium-Heparin Plasma and/or Serum 13x100 mm tubes.

y) Linearity samples for Quantitative results (if needed) covering the analytical measuring range of the instrument which are required every 6 months for all analytes due to a CAP requirement for maintaining assays and CLSI method validation to be provided by the contractor to validate the manufacturer’s claimed analytical measuring range.

z) Capability to detect out of range quality control.

aa) On-board QC data management system with storage capacity for all QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

ab) Biotin interference must be negligible/clinically insignificant.

5) INTERFACE REQUIREMENTS

a) The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface(Data Innovations Instrument manager) and any incremental fee that is required each time an instrument is added to an existing universal interface system

b) The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

c) If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

d) If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

6) CONSUMABLE/REAGENT REQUIREMENTS

a) All consumable supplies (reagents, standards, controls, linearity samples, disposables, parts, accessories, etc.) required for the proper operation of the contractor's equipment and necessary to perform tests on the equipment shall be included.

b) If the consumables 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 shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the respective Lab Facility, Pathology and Laboratory Medicine Department, 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 Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

c) The contractor shall maintain on Government provided space a continuously stocked inventory of controls, calibrators, reagents, supplies, disposables, parts, accessories, and any other material required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO).

d) 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 Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, 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 at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

7) MAINTENANCE, REPAIR AND UPGRADE REQUIREMENTS

a) With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract.

b) Equipment repair response time shall be no more than 24 hours.

c) Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable their maintenance representative to receive such notification. The contractor shall be on-site at the facility to perform emergency repair service within twenty-four (24) hours after receipt of initial telephone notification of a malfunction.

d) Contractor shall provide technical support service to assist in troubleshooting and provide maintenance coverage 24 hours a day, 7 days a week and 365 days per year.

e) In addition to above the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:

i. date and time notified;

ii. date and time of arrival;

iii. serial number, type and model number(s) of equipment;

iv. time spent for repair;

v. description of malfunction and repair; and

vi. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance and any other testing as needed.

f) During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance manufacturer’s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.

g) The contractor shall not leave a service call open pending verification that repairs are completed by the contractor’s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.

h) 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 shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement applies to “system upgrades” that enhance the models of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade due to significant changes in the hardware operational capability, upgrade offered to commercial customers at no additional charge, upgrade to replace models of equipment no longer Contractor supported.

8) TRAINING REQUIREMENTS

a) On-site training (at respective VA Medical Center) and key operator training for at least 2 operators per site per year paid for by the contractor.

b) 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 Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair.

c) If on-site training is not available and contractor can only provide off-site training, then the off-site training program shall be paid for by the contractor and shall include the costs of airfare, transportation, and room and board for at least 2 operators per site per year.

9) CHARACTERIZATION OF WASTES

a) Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results.

b) Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

c) The determination and description shall address the following:

i. Waste Toxicity

ii. Waste Ignitability

iii. Waste Corrosivity

iv. Waste Reactivity

v. Hazardous waste from non-specific sources (F-listed)

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

vii. Solid Waste

viii. Exclusions

d) The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

e) Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, Corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review.

f) At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response: Please include TOTALS for each i) – xv).

i. Barium

ii. Cadmium

iii. Chromium

iv. Copper

v. Lead

vi. Mercury

vii. Nickel

viii. Silver

ix. Zinc

x. Arsenic

xi. Selenium

xii. Tin

xiii. pH

xiv. Flash point (to higher than 200F)

xv. BOD; biochemical oxygen demand

g) The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system

10) TRANSITION PERIOD:

a) Upon award of the contract, within 30 days the awarded contractor shall have all ID and Procal and peripherals installed at the OKCVAMC.

b) Within 60 days of award the contractor shall complete all initial training of VA personnel in the operation, and maintenance of said equipment shall also be completed.

c) No later than 60 calendar days after award, the contractor shall have completed full transition of all services under this agreement to include all correlation studies, validations, etc., and shall have full and sole responsibility for equipment, supplies and services under the awarded contract.

d) Charges shall not apply no earlier than the first day of patient testing after all installation, training, and method validations have been completed. At this time, the awarded contractor shall have completed full transition of all equipment, supplies and services under this agreement and shall have full and sole responsibility for equipment, supplies and services under the awarded contract.

11) TERMS AND CONDITIONS:

a) With exception of terms and conditions as stated herein, contractor shall provide all equipment, supplies and services in accordance with the terms, conditions, provisions and schedule of contractor's existing and future FSS Contract for performance of ID and Procal CPRR contract services for the participating medical facility.

b) If, for any reason, a contractor ceases testing of any ID or Procal assays, the contractor shall notify the VA contracting officer 60 days prior to the assays being discontinued.

12) SECURITY

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

13) LOCATIONS

Oklahoma City VA Health Care System (113) 921 N.E. 13th st Oklahoma City Oklahoma, 73104 Chemistry Supervisor: Joseph Legault, 405-456-3187

B.3 SCHEDULE OF COSTS – 7/1/21 through 6/30/26

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(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 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 32.608-2 of the Federal Acquisition Regulation 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. 2409 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 is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of the contract end date.

The “specified” rates under this clause will be those rates in effect under the contract each time an option is exercised under this clause.

(End of Clause)

C.3 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

Funds are not presently available for performance under this contract beyond September 30th of any fiscal year. The Government's obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond September 30th of any fiscal year, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)

C.4 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/index.asp

(End of Clause)

C.5 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request…