36C25718Q9515-002.docx

36C25718Q9515

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 SI

GN 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. SIGN

ATURE 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

674-19-1-034-0011 36C25718Q9515 07-24-2018 Robyn Nussbaum 806-354-7830 08-07-2018 00504 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106 X X Y 325413 1250 Employees

NET 30

N/A X Department of Veterans Affairs P&LMS Section S 1st Street Temple TX 76504 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106

This is accomplished through the Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices

(877) 353-9791

(512) 460-5540 See CONTINUATION Page Please see Section B for Statement of Work and Price/Cost Schedule.

See CONTINUATION Page 674-3690160-034-822300-2633 010022300 X X X Mark Branum Contracting Officer 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 00504 Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106

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.

This is accomplished through the Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

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

This solicitation includes FAR 52.219-14 Limitations on Subcontracting. 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.3 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.

36C25718Q9515

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B.4 STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Semi-Automated Gel Electrophoresis

2. Purpose: Requesting the procurement a Semi-Automated Gel Electrophoresis through a Reagent Rental agreement.

3. Scope of Work: The contractor shall provide a semi-automated, gel electrophoresis instrument that can perform both serum and urine electrophoresis (SPEP/UPEP), and immunofixation (SIFE/UIFE) to identify monoclonal and polyclonal gammopathies.

4. Background: The Sebia Immunofixation instrument has been in use in the CTVHCS Chemistry Laboratory since before 2005. The capillary instrument was added around 2007.

5. Performance Period: Performance Period for this contract shall be one base year plus four option years

6. Type of Contract: This is a firm fixed-price contract.

B. GENERAL REQUIREMENTS

All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

C. TASKS, DELIVERABLES/SUPPLIES

The contractor shall provide a semi-automated, gel electrophoresis instruments capable of performing both serum and urine electrophoresis (SPEP/UPEP), and immunofixation (SIFE/UIFE) to identify monoclonal and polyclonal gammopathies. The instruments shall meet all technical specifications stated in the statement of work. Contractor shall provide all necessary maintenance to keep the equipment in good operating condition (including both preventative maintenance and emergency repairs) and training for Government personnel. Contractor is also required to provide delivery, installation, bi-directional interfacing, method validation, and removal of equipment upon completion of agreement.

1. Analyzer Requirements:

A. Capillary electrophoresis

· 8 Capillary electrophoresis Bench top analyzer

· Test menu: Protein 6, immunotyping

· Continuous sample loading

· Direct sampling from primary tube

· Positive sample identification, full traceability from primary tube to final result

· Barcoded reagents and controls B. Gel electrophoresis

· Semi-automated Gel electrophoresis bench top analyzer

· Test menu: Immunofixation, Bence Jones

· Sample types: Serum, urine

· Must have options of 1, 2, or 4 tests/gel

· Onboard densitometer scanner

C. Software

· Networking connection of instruments

· Multi-client configuration for different operators

· Automatic flagging of abnormal values

· Curve recall, review and editing

· Pre-programmed comments or manual entry

· Reference pattern overlay

· Unlimited storage of patient database

· Automatic patient history search

· Color coded profiles

· Bidirectional LIS connection

2. General Requirements:

Electrophoresis instruments shall produce accurate and reproducible assay results on serum or urine specimens for SPEP/UPEP and SIFE/UIFE electrophoresis by established in vitro diagnostic methods. Offered equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

A. Upgrades to the equipment hardware and operating system software shall be provided at no additional cost to the Government. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market.

B. An operator’s manual shall be furnished with each instrument supplied and updates to manual shall be provided in a timely manner. Editable electronic copy in CLSI format of operating procedures shall be furnished with each instrument supplied to the VA.

C. Laboratory assays currently performed shall include, but may not be limited to the following automated assays.

· Serum Protein Electrophoresis

· Serum Immunofixation.

· Urine Immunofixation.

D. Start-up Reagents and Supplies: The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other items required to establish instrument for operation and acceptance testing. The Contractor shall provide the Government with validation and method comparison studies. All materials and reagents needed for such correlation are at no cost to the Government. The Contractor shall perform all statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

E. All consumables, reagents, calibrators, controls, supplies, 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 shall be included if CPRR or RR.

F. Service Requirements: The Contractor shall be able to provide emergency equipment repair and preventative maintenance on the equipment.

· A technical assistance center shall be available by telephone 8 hours per day, 5 days per week with a maximum call back response time of 4 hours.

· Equipment repair service shall be provided during core business hours. 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 24 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:

· date and time notified

· date and time of arrival

· serial number, type and model number of equipment

· time spent for repair,

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

G. Flexibility in test volumes shall be considered.

H. Extended expiration date of supplies shall be provided.

I. Training for all testing personnel, and Key Operator training for a minimum of two operators is required.

J. Systems shall provide ease of use menus, with minimal maintenance required and simple troubleshooting processes.

3. Technical Requirements:

A. Equipment shall have a fully bi-directional, ASTM or HL7 Lab Information System (LIS) interfacing. All downloads/software necessary to transfer orders and data into patient files via LIS interface will be at no additional cost to VA.

B. Contractor shall provide at least one (1) each automated, auto-sampler instrument and (1) each automated electrophoresis/scanner instrument and peripherals C. Electrophoresis separation system shall have barcode reading capabilities to assure Positive Patient ID.

D. Electrophoresis instrument shall be a bench top model to fit into the current laboratory configuration.

E. Data backup shall be provided.

F. Uninterruptible power supply (surge protection, battery backup) shall be provided and serviced by the vendor for all associated electrical instruments and ancillary components excluding printer.

G. Imaging system must provide permanent file retention of non-modified pattern image.

Schedule of Deliverables

Item No.

Item

Semi-Automated Gel electrophoresis instrument Semi-Automated Immunofixation instrument

Quantity

Delivery Date

Within 60 calendar days after award

Reagents, Controls and consumables for SPEP testing Reagents, Controls and consumables for SIFE testing Reagents, Controls and consumables for UIFE testing

IDIQ

IDIQ

IDIQ

D. PERFORMANCE REQUIREMENTS

A. Maintenance: The contractor shall perform preventative maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

· Inventory and recording of systems components.

· Monthly deliverables shall be received in full.

· Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

· After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government.

· Delivery of PM parts or materials: the contractor shall provide all preventative service materials at no additional cost to the government.

· Repairs and support

· Technical support: Support Personnel will be available by telephone from 0800 to 1700 each business day.

· On site repairs: Contractor will dispatch on-site support personnel within 24 business hours of determining that phone support is insufficient to correct problem. After repair, the contractor shall submit a detailed work report to include all required materials at no charge to the facility.

B. For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost to the government.

C. Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to, but not limited to, repairs, replacements, recall, and upgrades without any cost to the government.

· Training: The contractor will provide training D. Safety: Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation.

E. Test Performance: All tests, procedures, and equipment must perform at manufacturer specifications. Deviations from the performance specifications shall be corrected by the contractor.

· All test performance will be evaluated by and not limited for performance thru peer comparison, quality control, and CAP peer evaluation.

F. Should consumables be 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.

E. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

F. CONTRACTOR SECURITY REQUIREMENTS

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

The C&A requirement do not apply. A security accreditation package is not required.

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

G. RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to Central Texas Veterans Healthcare System (CTVHCS) and must be returned to CTVHCS at the end of the contract.

H. QUALITY ASSURANCE SURVELLIANCE PLAN (QASP)

The QASP and its performance are as follows:

Method Incentive

Exercise of Option Period & Past Performance

Customer Satisfaction

B.5 PRICE/COST SCHEDULE

ITEM INFORMATION

HYDRASYS 2 WITH SCAN REAGENT RENTAL

Contract Period: Base POP Begin: 10-01-2018 POP End: 09-30-2019

LOCAL STOCK NUMBER: 1200

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 1227

HYDRAGEL 2 IF DYNAMIC MASK

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4302

HYDRAGEL 4 IF DYNAMIC MASK

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4304

HYDRAGEL 1 BENCE JONES DYNAMIC MASK

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4321

CLEAN PROTECT

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 2059

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4315

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4335K

HYDRASYS DESTAIN SOLUTION

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4540

HYDRASYS WASH SOLUTION

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4541

CAPILLARYS PROTEIN 1400 mL

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 2003

CAPILLARYS IT

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 2100

CAPILLARYS BUFFER

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 2043

CAPILLARYS WASH SOLUTION

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 2052

CAPICLEAN

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 2058

CLEAN PROTECT

POP Begin: 10-01-2018

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4785

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4787

IT/IF CONTROL

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 4788

CAPY FLEX WEDGE ADAPTORS

POP Begin: 10-01-2018

LOCAL STOCK NUMBER: 9203

HYDRASYS 2 WITH SCAN REAGENT RENTAL

Contract Period: Option 1 POP Begin: 10-01-2019 POP End: 09-30-2020

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 10-01-2019

HYDRAGEL 2 IF DYNAMIC MASK

POP Begin: 10-01-2019

HYDRAGEL 4 IF DYNAMIC MASK

POP Begin: 10-01-2019

HYDRAGEL 1 BENCE JONES DYNAMIC MASK

POP Begin: 10-01-2019

CLEAN PROTECT

POP Begin: 10-01-2019

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 10-01-2019

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 10-01-2019

HYDRASYS DESTAIN SOLUTION

POP Begin: 10-01-2019

HYDRASYS WASH SOLUTION

POP Begin: 10-01-2019

CAPILLARYS PROTEIN 1400 mL

POP Begin: 10-01-2019

CAPILLARYS IT

POP Begin: 10-01-2019

CAPILLARYS BUFFER

POP Begin: 10-01-2019

CAPILLARYS WASH SOLUTION

POP Begin: 10-01-2019

CAPICLEAN

POP Begin: 10-01-2019

CLEAN PROTECT

POP Begin: 10-01-2019

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 10-01-2019

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 10-01-2019

IT/IF CONTROL

POP Begin: 10-01-2019

CAPY FLEX WEDGE ADAPTORS

POP Begin: 10-01-2019

HYDRASYS 2 WITH SCAN REAGENT RENTAL

Contract Period: Option 2 POP Begin: 10-01-2020 POP End: 09-30-2021

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 10-01-2020

HYDRAGEL 2 IF DYNAMIC MASK

POP Begin: 10-01-2020

HYDRAGEL 4 IF DYNAMIC MASK

POP Begin: 10-01-2020

HYDRAGEL 1 BENCE JONES DYNAMIC MASK

POP Begin: 10-01-2020

CLEAN PROTECT

POP Begin: 10-01-2020

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 10-01-2020

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 10-01-2020

HYDRASYS DESTAIN SOLUTION

POP Begin: 10-01-2020

HYDRASYS WASH SOLUTION

POP Begin: 10-01-2020

CAPILLARYS PROTEIN 1400 mL

POP Begin: 10-01-2020

CAPILLARYS IT

POP Begin: 10-01-2020

CAPILLARYS BUFFER

POP Begin: 10-01-2020

CAPILLARYS WASH SOLUTION

POP Begin: 10-01-2020

CAPICLEAN

POP Begin: 10-01-2020

CLEAN PROTECT

POP Begin: 10-01-2020

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 10-01-2020

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 10-01-2020

IT/IF CONTROL

POP Begin: 10-01-2020

CAPY FLEX WEDGE ADAPTORS

POP Begin: 10-01-2020

HYDRASYS 2 WITH SCAN REAGENT RENTAL

Contract Period: Option 3 POP Begin: 10-01-2021 POP End: 09-30-2022

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 10-01-2021

HYDRAGEL 2 IF DYNAMIC MASK

POP Begin: 10-01-2021

HYDRAGEL 4 IF DYNAMIC MASK

POP Begin: 10-01-2021

HYDRAGEL 1 BENCE JONES DYNAMIC MASK

POP Begin: 10-01-2021

CLEAN PROTECT

POP Begin: 10-01-2021

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 10-01-2021

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 10-01-2021

HYDRASYS DESTAIN SOLUTION

POP Begin: 10-01-2021

HYDRASYS WASH SOLUTION

POP Begin: 10-01-2021

CAPILLARYS PROTEIN 1400 mL

POP Begin: 10-01-2021

CAPILLARYS IT

POP Begin: 10-01-2021

CAPILLARYS BUFFER

POP Begin: 10-01-2021

CAPILLARYS WASH SOLUTION

POP Begin: 10-01-2021

CAPICLEAN

POP Begin: 10-01-2021

CLEAN PROTECT

POP Begin: 10-01-2021

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 10-01-2021

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 10-01-2021

IT/IF CONTROL

POP Begin: 10-01-2021

CAPY FLEX WEDGE ADAPTORS

POP Begin: 10-01-2021

HYDRASYS 2 WITH SCAN REAGENT RENTAL

Contract Period: Option 4 POP Begin: 10-01-2022 POP End: 09-30-2023

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 10-01-2022

HYDRAGEL 2 IF DYNAMIC MASK

POP Begin: 10-01-2022

HYDRAGEL 4 IF DYNAMIC MASK

POP Begin: 10-01-2022

HYDRAGEL 1 BENCE JONES DYNAMIC MASK

POP Begin: 10-01-2022

CLEAN PROTECT

POP Begin: 10-01-2022

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 10-01-2022

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 10-01-2022

HYDRASYS DESTAIN SOLUTION

POP Begin: 10-01-2022

HYDRASYS WASH SOLUTION

POP Begin: 10-01-2022

CAPILLARYS PROTEIN 1400 mL

POP Begin: 10-01-2022

CAPILLARYS IT

POP Begin: 10-01-2022

CAPILLARYS BUFFER

POP Begin: 10-01-2022

CAPILLARYS WASH SOLUTION

POP Begin: 10-01-2022

CAPICLEAN

POP Begin: 10-01-2022

CLEAN PROTECT

POP Begin: 10-01-2022

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 10-01-2022

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 10-01-2022

IT/IF CONTROL

POP Begin: 10-01-2022

CAPY FLEX WEDGE ADAPTORS

POP Begin: 10-01-2022

Statement of Work

Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 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.)

[X] (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).

[X] (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.

[X] (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)).

[X] (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).

[X] (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)).

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

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

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

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

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

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

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

[X] (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.

[X] (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).

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

(xix) 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).

(xx) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxi) 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). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of Clause) C.3 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE ITEM (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.4 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 expiration.

(End of Clause)

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

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days of expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended…