36C25718Q9916-001.docx

36C25718Q9916 FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 SX eSensor XT8 analyzer lease, and purchase HCV genome test kit reagents 75216 36C25718Q9916 09-24-2018 N 334516 Department of Veterans Affairs NCO 17 North Texas Healthcare System NCO 17 Network Contracting Activity 4500 S. Lancaster Road Dallas TX 75216 Grace Barr Grace.Barr@Va.Gov VA North Texas Health Care System 4500 S Lancaster Rd Dallas, TX 75216 Grace.Barr@Va.Gov grace.barr@va.gov The Department of Veterans Affairs, North Texas VA Health Care System (NTVAHCS) at 4500 S. Lancaster Rd, Dallas, Tx 75216 has a requirement for SX eSensor XT8 analyzer lease, and purchase HCV genome test kit reagents.

The applicable NAICS code is 334516 Analytical Laboratory Instrument Manufacturing. Small Business manufacturers for this NAICS code have a size standard of 1000 employees. The resulting contract will be a firm fixed price contract. The period of performance shall begin no later than 10/01/2018 and shall be active through 9/30/2019. The intent of the procurement is to award a base plus 4 option years.

The response date to this solicitation is Sept 24, 2018 at 9am CST time. This solicitation is total Small Business set-aside. The Government will not pay any costs for responses submitted. Electronic submissions are acceptable directly Grace.Barr@va.gov.

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

549-19-1-052-0006 36C25718Q9916 09-14-2018 Grace Barr 972-708-0817 09-25-2018 9am Department of Veterans Affairs Contracting Section 4500 S. Lancaster Rd.

Dallas TX 75216 X 334516 1250 Employees N/A X Department of Veterans Affairs Laboratory Section 4500 S Lancaster Rd Dallas TX 75216 00504 Department of Veterans Affairs Contracting Section 4500 S. Lancaster Rd.

Dallas TX 79106

Department of Veterans Affairs

FMS-VA-FSC

PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page DX eSensor XT8 System and HCVgenome tests North Texas VA Healthcare Facility IAW Price/Cost Schedule and Statement of Work (SOW) See CONTINUATION Page 549-3690160-052-822300 -3131 -010022300 X x X Mark Branum Contracting Officer

Page 1 of

Page 1 of

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257 00549 Department of Veterans Affairs Contracting Section 4500 S. Lancaster Rd Dallas, TX 75216

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

FMS-VA-FSC

PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.1 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.2 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

36C25718Q9916

Page 1 of Page 1 of Page 1 of Page 1 of Statement of Work

For Rental Agreement for the Dx maintenance free electrochemical detection platform (eSensor XT8) Complete System, and Purchase Laboratory Reagents, and Supplies for Performing the Hepatitis C Genotyping Direct Assay

1. Purpose VA North Texas Health Care System is requesting to lease a maintenance free electrochemical detection platform DX eSensor XT8 System and purchase HCVg tests through reagent rental purchase agreement. The vendor’s Cost-per-Test Pricing Proposal will be based on estimated workload volumes of 1200 Hepatitis C Genotyping Direct tests per year for a base plus 4 Option year agreement.

2. Scope The contractor will provide the eSensor XT8 System analyzer, two (2) analyzer modules, printer pack, and accessory kit. The contractor may be required to install additional modules based on workload volumes and result turn-around-times. Any additional towers/ instruments will be be contracted by an addendum. The contractor will provide onsite instrument installation and start-up, on-site instrument test validation, technical support and guidance, and on-site training for testing personnel. The eSensor XT8 is a random access analyzer capable of processing up to 24 tests simultaneously and requires no routine maintenance or instrument calibration. The eSensor HCVg (genotype) Direct Test is designed to genotype a panel of eight (8) prevalent HCV type/subtypes (1a, 1b, 2a/c, 2b, 3, 4, 5 and 6), using a multiplex RT (reverse transcriptase) – PCR amplification of extracted nucleic acid followed by a direct analysis on the electrochemical eSensor XT-8 detection system. The system utilizes a proprietary eSensor technology where the target DNA is mixed with the signal probe solution in the cartridge and analyzed via solid-phase electrochemical method using voltammetry to detect specific signal generated by the hybridization of ferrocene-labeled signal probes. The cartridge is pre-programmed with the test protocol, lot number, and expiration date on an internal memory chip to minimize errors. Testing should require minimal training time. Extracted sample set-up time is seven (7) minutes, and 40 minutes total tech hands on time. Test results are available in 4.5 hours. All reporting is automatic and consists of all relevant types and subtypes. No manual reading is required. Automated (interfaced) reporting eliminates the need for manual interpretation and manual data entry and the incidence of interpretation errors. The XT-8 can be interfaced with lab systems through Data Innovations (DI). Technical support is available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries. On-site technical support is available for escalations within 48 hours. In cases where issues with the modules cannot be resolved over the phone, the contractor will exchange the module with a new unit. Technical support will analyze the reported issue and will make a final decision for module (or tower) replacement. The contractor will ship the exchange module the next business day (if reported before 2pm CST) to arrive within 48 hours. The failed module will be shipped back to contractor. The contractor will pay all shipping costs for return of the failed module and shipping costs for the exchanged module. Pathology & Laboratory Medicine Service (P&LMS) at the Dallas VA North Texas Health Care System (VANTHCS) will order reagents and supplies from contractor. as needed to perform Hepatitis C genotyping Direct testing on the Dx eSensor XT8 analyzer, which will be located in the P&LMS, Dallas VANTHCS.

3. Location The Dx eSensor XT8 analyzer will be located and testing will be performed in the Molecular Diagnostics Laboratory of P&LMS, Dallas VANTHCS.

4. Performance Requirements Maintenance: The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

5. Period of Performance See Section B.2 -Price/Cost Schedule

6. Deliverables/Supplies This order is for the cost per test procurement of the Dx eSensor XT8 analyzer. Reagents and supplies will be purchased under the terms of the reagent rental purchase agreement.

7. Salient Characters

7.1 Instrument must consist of the following to meet the needs of the customer:

· Assay must accommodate specimens extracted using the Roche MagNaPure 96 Instrument IVD.

· Is random access

· Has a total time to result of 4.5 hours

· Requires less than 10 minutes total hands on load time per specimen and less than 45 minutes total hands on time

· Automatically reads and provides genotype – no interpretation required.

· Can be interfaced with VistA

· Is able to detect the following subtypes: 1a, 1b, 2a/c, 2b, 3, 4, 5 and 6

· Is a bench top instrument with a footprint no larger than 20" x 16" x 16.5"

· Is capable of testing up to 24 specimens

· No routine maintenance or calibrations required

· Ability to add additional tests to the platform: CYP450 2C9 (*2 and *3), Factor V (Leiden), MTHFR 677 and 1298

· Capable of testing multiple assays simultaneously

· Does not use the following software: Windows XP Embedded Service Pack 3, Windows Server 2003 or Windows XP

· Company has the ability to provide an upgraded analyzer if needed when testing volume increases (subject to addendum)

8. Contractor Security Contract Requirements.

This contractor requires no access to VANTHCS or any VA information system. The Dx eSensor XT8 analyzer will be interfaced to the VANTHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

9. Records Management All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.

10. Quality Assurance Surveillance Plan (QASP) and its performance are as follows:

Scoring – Average score value per category:

· Exceptional – 4

· Very Good – 3

· Satisfactory – 2

· Marginal – 1

· Unsatisfactory <1

(CPARS)

Repeat runs are minimal due to reagent or instrument issues.

Exceptional: 0 Very Good: 1 Satisfactory: 2 Marginal: 3 Unsatisfactory: >3

· Troubleshooting records

· Service records Exercise of Option Period

Minimal unsuccessful performance due to instrument or reagent issues.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

Instrument downtime is minimal.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Troubleshooting records

· Service Records

· Sendout records

· TAT reports

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Troubleshooting records

· Service records Exercise of Option Period

Vendor initiates scheduling of preventive maintenance.

Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85%

· Service records

· Problem records

Telephone Support is responsive.

Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85%

· Troubleshooting records

· Problem records

· Service records Exercise of Option Period

Invoices are itemized by service or product received.

Excellent: 95-100% Very Good: 90-94% Satisfactory: 85-89% Marginal: 80-84% Unsatisfactory: <80%

Excellent: 0% Very Good: 1-2% Satisfactory: 3-4% Marginal: 5% Unsatisfactory: >5%

· Order records

· Invoice records

· Customer communications Exercise of Option Period

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Order records

· Invoice records

· Customer communications Exercise of Option Period

Contractor will provide proactive notification of changes.

· Quality Bulletins

· Customer Letters

· Customer Contact Exercise of Option Period

Timely recall notification of reagent and supplies.

· Customer Letters

· Customer Contact Exercise of Option Period

· Invoice records

· Customer communications

· Problem records

· Troubleshooting records Exercise of Option Period

Timely follow-up on complaints.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Order records

· Invoice records

· Customer communications

· Problem records

· Troubleshooting records Exercise of Option Period

NARA RM Language Clause to be included in contracts, as necessary:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

References:

VHA Directive 6300 VA Handbook 6300.1 North Texas VA Medical Center Policy VA Directive 6500 36 CFR Part 1222.32 (b)

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

eSensor XT-8 System - 2 Analyzer Module RM002068 eSensor XT-8 Accessory Kit IS002100 eSensor XT-8 Printer Pack MT002007 12 Month Service Plan - 2 Analyzer Module SV002068P (Qty4) ALL PREVENTATIVE MAI Contract Period: Base POP Begin: 10-01-2018 POP End: 09-30-2019

ITEM Description: eSensor HCVg Direct Test Kit (RUO), 24 Cartridges/Kit ITEM NUMBER: MT008102 UNIT: KIT COST: $2,376/KIT ESTIMATED MONTHLY COST: $9,900.00

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: MT008102

FREIGHT FOR REAGENT SHIPPING ESTIMATED COST PER SHIPMENT $80.00 ESTIMATED TOTAL VOLUME PER SHIPMENT: $960.00 COST MAY VARY DEPENDING UPON NUMBER OF KITS ORDERED.

POP Begin: 10-01-2018

eSensor XT-8 System - 2 Analyzer Module RM002068 eSensor XT-8 Accessory Kit IS002100 eSensor XT-8 Printer Pack MT002007 12 Month Service Plan - 2 Analyzer Module SV002068P (Qty4) ALL PREVENTATIVE MAI Contract Period: Option 1 POP Begin: 10-01-2019 POP End: 09-30-2020

ITEM Description: eSensor HCVg Direct Test Kit (RUO), 24 Cartridges/Kit ITEM NUMBER: MT008102 UNIT: KIT COST: $2,376/KIT ESTIMATED MONTHLY COST: $9,900.00

POP Begin: 10-01-2019

FREIGHT FOR REAGENT SHIPPING ESTIMATED COST PER SHIPMENT $80.00 ESTIMATED TOTAL VOLUME PER SHIPMENT: $960.00 COST MAY VARY DEPENDING UPON NUMBER OF KITS ORDERED.

POP Begin: 10-01-2019

eSensor XT-8 System - 2 Analyzer Module RM002068 eSensor XT-8 Accessory Kit IS002100 eSensor XT-8 Printer Pack MT002007 12 Month Service Plan - 2 Analyzer Module SV002068P (Qty4) ALL PREVENTATIVE MAI Contract Period: Option 2 POP Begin: 10-01-2020 POP End: 09-30-2021

ITEM Description: eSensor HCVg Direct Test Kit (RUO), 24 Cartridges/Kit ITEM NUMBER: MT008102 UNIT: KIT COST: $2,376/KIT ESTIMATED MONTHLY COST: $9,900.00

POP Begin: 10-01-2020

FREIGHT FOR REAGENT SHIPPING ESTIMATED COST PER SHIPMENT $80.00 ESTIMATED TOTAL VOLUME PER SHIPMENT: $960.00 COST MAY VARY DEPENDING UPON NUMBER OF KITS ORDERED.

POP Begin: 10-01-2020

eSensor XT-8 System - 2 Analyzer Module RM002068 eSensor XT-8 Accessory Kit IS002100 eSensor XT-8 Printer Pack MT002007 12 Month Service Plan - 2 Analyzer Module SV002068P (Qty4) ALL PREVENTATIVE MAI Contract Period: Option 3 POP Begin: 10-01-2021 POP End: 09-30-2022

ITEM Description: eSensor HCVg Direct Test Kit (RUO), 24 Cartridges/Kit ITEM NUMBER: MT008102 UNIT: KIT COST: $2,376/KIT ESTIMATED MONTHLY COST: $9,900.00

POP Begin: 10-01-2021

FREIGHT FOR REAGENT SHIPPING ESTIMATED COST PER SHIPMENT $80.00 ESTIMATED TOTAL VOLUME PER SHIPMENT: $960.00 COST MAY VARY DEPENDING UPON NUMBER OF KITS ORDERED.

POP Begin: 10-01-2021

eSensor XT-8 System - 2 Analyzer Module RM002068 eSensor XT-8 Accessory Kit IS002100 eSensor XT-8 Printer Pack MT002007 12 Month Service Plan - 2 Analyzer Module SV002068P (Qty4) ALL PREVENTATIVE MAI Contract Period: Option 4 POP Begin: 10-01-2022 POP End: 09-30-2023

ITEM Description: eSensor HCVg Direct Test Kit (RUO), 24 Cartridges/Kit ITEM NUMBER: MT008102 UNIT: KIT COST: $2,376/KIT ESTIMATED MONTHLY COST: $9,900.00

POP Begin: 10-01-2022

FREIGHT FOR REAGENT SHIPPING ESTIMATED COST PER SHIPMENT $80.00 ESTIMATED TOTAL VOLUME PER SHIPMENT: $960.00 COST MAY VARY DEPENDING UPON NUMBER OF KITS ORDERED.

POP Begin: 10-01-2022

Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 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/ C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(3) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[x] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509).

[] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (OCT 2016) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note).

[] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a).

[] (ii) Alternate I (NOV 2011) of 52.219-3.

[] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (JAN 2011) of 52.219-4.

[] (13) [Reserved] [x] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).

[] (ii) Alternate I (NOV 2011).

[] (iii) Alternate II (NOV 2011).

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

[] (ii) Alternate I (Oct 1995) of 52.219-7.

[] (iii) Alternate II (Mar 2004) of 52.219-7.

[] (16) 52.219-8, Utilization of Small Business Concerns (NOV 2016) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219-9, Small Business Subcontracting Plan (JAN 2017) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (NOV 2016) of 52.219-9.

[] (v) Alternate IV (NOV 2016) of 52.219-9.

[] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).

[] (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f).

[] (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C 632(a)(2)).

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (DEC 2015) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (DEC 2015) (15 U.S.C. 637(m)).

[] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[] (26) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2018) (E.O. 13126).

[] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[] (28) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (29) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

[] (30) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

[] (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

[] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[x] (33)(i) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[] (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C. 8259b).

[] (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[x] (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) [] (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

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

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

[] (46) 52.225-1, Buy American—Supplies (MAY 2014) (41 U.S.C. chapter 83).

[] (47)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[] (ii) Alternate I (MAY 2014) of 52.225-3.

[] (iii) Alternate II (MAY 2014) of 52.225-3.

[] (iv) Alternate III (MAY 2014) of 52.225-3.

[] (48) 52.225–5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[] (49) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[] (50) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

[] (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[] (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[] (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[] (54) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[X] (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

[] (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

[] (57) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

[] (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)).

[] (60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

[] (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[] (1) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495).

[] (2) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67).

[] (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[] (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

[] (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

[] (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792).

[] (11) 52.237-11, Accepting and Dispensing of $1 Coin (SEP 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (NOV 2016) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities.

(iv) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

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

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

(vii) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

(ix) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

(x) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xi) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67).

(xii)(A) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627).

(B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xiii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xiv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E. O. 12989).

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015).

(xvii) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xviii)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B)…