W9114F-20-Q-0051.pdf

SEE ADDENDUM

(No Collect Calls)

W9114F20Q0051 23-Apr-2020

b. TELEPHONE NUMBER

49 6371 9464 6550

8. OFFER DUE DATE/LOCAL TIME

12:00 PM 15 May 2020

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W9114F9. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

DONNA M. KABATEK

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0011431841

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

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

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M RHCO USAHCA EUROPE

KIRCHBERG KASERNE BLDG 3705

LANDSWEILER STRASSE

LANDSTUHL 66849

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE WK4FW0 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

LANDSTUHL REGIONAL MEDICAL CENTER

LANDSTUHL REGIONAL MEDICAL CENTER

3738 BLDG

LANDSTUHL / KIRCHBERG 66849

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

339112

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

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

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF20

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W9114F20Q0051

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 106,800 Each Automated Immunology Testing Platform

FFP

The Vendor shall provide all labor, materials and transportation necessary to provide one (1) new, fully-automated immunoassay testing platform on a cost-per-reportable test basis with the purchase of reagents. The system must be a fully automated, random access immunoassay system using direct or indirect chemiluminescence or fluorescence. Assay method must be able to perform FDA-approved tests capable of producing clinical results in accordance with the College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. Items included are the analyzer, printer, training, supplies, reagents, controls, unscheduled maintenance, and preventive maintenance for the equipment. The system will be able to test for the following analytes as listed in the Salient Characteristics: CMV IgG / IgM, HSV 1/2 IgG,Mumps IgG, Rubeola IgG, Varicella-zoster virus IgG, Lyme IgG / IgM. The Offeror is responsible for customer service and support 24 hours/7 days a week to ensure continued ability to conduct assays.

Initial method validations, per CLIA/NCCLS guidelines, are included and also outlined in the Salient Characteristics.

The period during which delivery is expected on the CLIN is 1 June 2020 – 31 May 2021.

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

PURCHASE REQUEST NUMBER: 0011431841

PSC CD: 6515

NET AMT

1001 106,800 Each OPTION Automated Immunology Testing Platform

FFP

The Vendor shall provide all labor, materials and transportation necessary to provide one (1) new, fully-automated immunoassay testing platform on a cost-per-reportable test basis with the purchase of reagents. The system must be a fully automated, random access immunoassay system using direct or indirect chemiluminescence or fluorescence. Assay method must be able to perform FDA-approved tests capable of producing clinical results in accordance with the College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. Items included are the analyzer, printer, training, supplies, reagents, controls, unscheduled maintenance, and preventive maintenance for the equipment. The system will be able to test for the following analytes as listed in the Salient Characteristics: CMV IgG / IgM, HSV 1/2 IgG,Mumps IgG, Rubeola IgG, Varicella-zoster virus IgG, Lyme IgG / IgM. The Offeror is responsible for customer service and support 24 hours/7 days a week to ensure continued ability to conduct assays.

Initial method validations, per CLIA/NCCLS guidelines, are included and also outlined in the Salient Characteristics.

The period during which delivery is expected on the CLIN is 1 June 2021 – 31 May 2022.

unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

2001 106,800 Each OPTION Automated Immunology Testing Platform

FFP

The Vendor shall provide all labor, materials and transportation necessary to provide one (1) new, fully-automated immunoassay testing platform on a cost-per-reportable test basis with the purchase of reagents. The system must be a fully automated, random access immunoassay system using direct or indirect chemiluminescence or fluorescence. Assay method must be able to perform FDA-approved tests capable of producing clinical results in accordance with the College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. Items included are the analyzer, printer, training, supplies, reagents, controls, unscheduled maintenance, and preventive maintenance for the equipment. The system will be able to test for the following analytes as listed in the Salient Characteristics: CMV IgG / IgM, HSV 1/2 IgG,Mumps IgG, Rubeola IgG, Varicella-zoster virus IgG, Lyme IgG / IgM. The Offeror is responsible for customer service and support 24 hours/7 days a week to ensure continued ability to conduct assays.

Initial method validations, per CLIA/NCCLS guidelines, are included and also outlined in the Salient Characteristics.

The period during which delivery is expected on the CLIN is 1 June 2022 – 31 May 2023.

unique identification or a DoD recognized unique identification equivalent.

3001 106,800 Each OPTION Automated Immunology Testing Platform

FFP

The Vendor shall provide all labor, materials and transportation necessary to provide one (1) new, fully-automated immunoassay testing platform on a cost-per-reportable test basis with the purchase of reagents. The system must be a fully automated, random access immunoassay system using direct or indirect chemiluminescence or fluorescence. Assay method must be able to perform FDA-approved tests capable of producing clinical results in accordance with the College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. Items included are the analyzer, printer, training, supplies, reagents, controls, unscheduled maintenance, and preventive maintenance for the equipment. The system will be able to test for the following analytes as listed in the Salient Characteristics: CMV IgG / IgM, HSV 1/2 IgG,Mumps IgG, Rubeola IgG, Varicella-zoster virus IgG, Lyme IgG / IgM. The Offeror is responsible for customer service and support 24 hours/7 days a week to ensure continued ability to conduct assays.

Initial method validations, per CLIA/NCCLS guidelines, are included and also outlined in the Salient Characteristics.

The period during which delivery is expected on the CLIN is 1 June 2023 – 31 May 2024.

unique identification or a DoD recognized unique identification equivalent.

4001 106,800 Each OPTION Automated Immunology Testing Platform

FFP

The Vendor shall provide all labor, materials and transportation necessary to provide one (1) new, fully-automated immunoassay testing platform on a cost-per-reportable test basis with the purchase of reagents. The system must be a fully automated, random access immunoassay system using direct or indirect chemiluminescence or fluorescence. Assay method must be able to perform FDA-approved tests capable of producing clinical results in accordance with the College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. Items included are the analyzer, printer, training, supplies, reagents, controls, unscheduled maintenance, and preventive maintenance for the equipment. The system will be able to test for the following analytes as listed in the Salient Characteristics: CMV IgG / IgM, HSV 1/2 IgG,Mumps IgG, Rubeola IgG, Varicella-zoster virus IgG, Lyme IgG / IgM. The Offeror is responsible for customer service and support 24 hours/7 days a week to ensure continued ability to conduct assays.

Initial method validations, per CLIA/NCCLS guidelines, are included and also outlined in the Salient Characteristics.

The period during which delivery is expected on the CLIN is 1 June 2024 – 31 May 2025.

unique identification or a DoD recognized unique identification equivalent.

SALIENT CHARACTERISTICS

Immunology Testing Platform Description – The Contractor shall provide an automated immunoassay analyzer capable of running FDA approved assays for all required tests. Additionally, the Contractor will provide all necessary reagents, training, supplies, unscheduled maintenance, and preventive maintenance for the equipment. Assay method must be capable of producing clinical results in accordance with the College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines. The analyzer shall be installed at the LRMC, building 3738 Room 113, 66849 Landstuhl/Kirchberg, Germany. The contract for this equipment shall include all reagents and materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS guidelines, and analyzer removal at the termination of the contract.

1) The system must be a fully automated, random access immunoassay system using direct or indirect chemiluminescence or fluorescence while providing continuous operation. The system should be able to load/unload samples and consumables during operational use without the need to interrupt system operations to include but not limited to sample racks, reagent packs, ancillary reagent packs, cuvettes, pipette tips, calibrators, controls, wash fluid, water, and waste.

2) Assay method must be able to perform FDA approved tests capable of producing clinical results in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines for the following analytes:

a. CMV IgG / IgM

b. HSV 1/2 IgG

c. Mumps IgG

d. Rubeola IgG

e. Varicella-zoster virus IgG

f. Lyme IgG / IgM

3) The system will have the ability to expand testing capabilities.

4) Method Validation (Correlation Studies), which will include parallel runs with existing equipment with not less than 40 but not more than 80 samples per analyte is required.

5) The software must maintain records of quality control materials and provide analysis following Westgard Rules and construction of Levy-Jennings plots. The system must meet DIACAP standards.

6) The system must be capable of conducting sample processing (pipetting, loading samples, and reagents), automatic dilutions, and measurement of sample.

7) The productivity and efficiency will include a minimum testing capacity of 100 tests per hour and be able to effectively manage both high and low volume tests with no-pause loading and unloading with a universal rack that holds multiple specimen tube types.

8) The system must utilize ready-loaded assay packs and store these primary and ancillary reagents onboard in a temperature-controlled compartment. The primary and ancillary reagent trays must remain cooled to 4‒ 8oC with automatic mixing. The system should also possess the ability to identify and monitor levels of reagents and inventory utilizing a barcode / QR reader. Must be able to store reagents and ancillary reagents on the System with a minimum onboard reagent capacity of 15 assays.

9) Instrument software should be able to track inventory, calculate reagent shortages for scheduled tests, and produce flags when reagent levels reach critically low levels. Additionally, the system should be capable of tracking reagent onboard stability, expiration dates, and calibration validity. The system interface should flag the user when low levels or expiration dates are reached. The system must be able to archive data and to store calibration data for a minimum of 28 days.

10) The system must include a sample barcode reader with the capability to link patient identifier to results.

11) The system should allow for single sample testing, batch testing and testing of multiple assays at the same time.

12) The system must have an integrated software system that calculates the final result and is fully compatible with the Composite Health Care System (CHCS).

13) Electrical requirement for this equipment shall be 220V/50Hz. Must be equipped with an un-interruptible power supply capable of providing all necessary electrical power to the analyzer system for 15 to 20 minutes.

14) All equipment displays and supporting literature, to include safety data sheets, shall be in English.

15) The analyzer, to include all associated parts and accessories, shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

16) The Contractor shall provide non-personal services to include, all personnel, equipment, tools, materials, supervision and training necessary to provide scheduled and unscheduled maintenance and repair of the system to ensure system is clinically operational in accordance with College of American Pathologist (CAP) and CLIP/CLIA/CLSI guidelines.

17) Reagents

a. All reagents provided shall be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they shall be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing.

b. All reagents must be functional through the life of the reagent (e.g. expiration date). All non-functional reagents (e.g. failed runs), where non-functionality cannot be attributed to technician error, must be replaced by the Contractor.

c. Reagents and Controls must be received at the required temperature indicated on the product insert and have a shelf life of at least 3 months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice). Reagents and Controls falling outside these specifications must be replaced by the Contractor.

d. Unscheduled and emergency orders and delivery shall be permitted. Emergency orders shall be delivered as soon as possible, but not more than ten (10) business days.

18) The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the system as clinically operational in accordance with CAP and CLIP/CLIA/CLSI guidelines to include all repair and replacement of defective and other parts, complete maintenance program (as required by the manufacturer’s maintenance manuals) and calibration, in addition to hotline telephone service, to assist operators in troubleshooting problems.

19) Upon notification of equipment failure, the Contractor shall respond to telephonic requests for unscheduled repair within two (2) business days. Should the analyzer at LRMC become inoperable, the Contractor’s Repair service engineer shall respond to telephonic requests for unscheduled repair within three (3) business days. If the equipment is out of service for longer than five (5) business days (from the time of service technician’s arrival on site), the Contractor shall notify the COR, in writing, as to the reason(s) (i.e. non-availability of parts, etc.) for non-compliance. If the equipment cannot be repaired, a replacement instrument shall be provided within ten (10) business days. If the equipment cannot be replaced within ten (10) business days, the Government may seek remedies for damages in accordance with FAR 52.212-4(a) Inspection/Acceptance.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 31-MAY-2021 106,800 LANDSTUHL REGIONAL MEDICAL

CENTER

LANDSTUHL REGIONAL MEDICAL

CENTER

3738 BLDG

LANDSTUHL / KIRCHBERG 66849

WK4FW0

1001 31-MAY-2022 106,800 (SAME AS PREVIOUS LOCATION)

2001 31-MAY-2023 106,800 (SAME AS PREVIOUS LOCATION)

3001 31-MAY-2024 106,800 (SAME AS PREVIOUS LOCATION)

4001 31-MAY-2025 106,800 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items OCT 2018

ADDENDUM TO 52.212-4

Amend Paragraph 52.212-4(a) to include - The contractor shall provide the following, and by returning a signed copy of your quote, the contractor affirms that its quote meets the eight (8) items:

(1) Electrical requirements are 220-240 Volt, 50-60 Hz.

(2) Include appropriate power cord.

(3) Two paper copies and one electronic copy of Operator's Manual in English.

(4) Two paper copies and one electronic copy of Maintenance Manual in English.

(5) Display and control labels shall be in English.

(6) A Statement from vendor of the warranty terms and conditions in English.

(7) The delivered equipment shall be new and not a used or re-manufactured product.

(8) Statement from vendor that the equipment possesses or meets the FDA certification requirements or statement of 510K processing for compliance as required.

Add paragraph 52.212-4(w) - SHARP - Advisory publications Army Regulation 600-20, Army Command Policy, 6 November 2014.

OTSG/MEDCOM Policy Memo 19-0019, Sexual Harassment/Assault Response and Prevention (SHARP) Program, 21 March 2019

The following provisions/clauses have been incorporated by reference and are required to be completed by the Offeror and submitted with your quote as necessary:

52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

OCT 2018

52.204-13 System for Award Management Maintenance OCT 2018 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.209-6 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters

OCT 2018

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations

NOV 2015

52.222-19 Child Labor -- Cooperation with Authorities and Remedies JAN 2020 52.222-50 Alt I Combating Trafficking in Persons (JAN 2019) Alternate I MAR 2015

INFO FOR PARAGRAPH(C)(1)(I)(B)

Document Title: Army in Europe Circular 190-24 Consolidated List of Off-Limits Areas, Establishments, Firms, Individuals and Organizations; obtain document at - https://media.defense.fob/2019/Mar/07/2002097126/-1/- 1/0/AEC190-24.pdf ; applies to performance in/at - The United States European Command area of responsibility.

52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

AUG 2011

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

OCT 2018

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

DEC 2013

52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.211-7003 Item Unique Identification and Valuation MAR 2016 252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7041 Correspondence in English JUN 1997 252.225-7043 Antiterrorism/Force Protection Policy for Defense

Contractors Outside the United States

JUN 2015

FILL-IN AT PARA.(D):

HQDA-AT; telephone, DSN 312-222-9832 or commercial (703) 692-9832)

252.229-7000 Invoices Exclusive of Taxes or Duties JUN 1997 252.229-7001 Tax Relief SEP 2014

CONTRACTOR FILLS IN:

NAME OF TAX: VAT RATE: 19

(Offeror Inserts) (Offeror Inserts)

252.229-7002 Customs Exemptions (Germany) JUN 1997 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (DEVIATION 2018-O0021) (MAR 2020)

(a) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph

(a) 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.

(b)(1) Notwithstanding the requirements of any other clauses of this contract, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (b) (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) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 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.

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

(viii) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

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

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

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

(xii) 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.

(xiii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xiv)(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).

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

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

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

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

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

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

(B) Alternate I (JAN 2017) of 52.224-3.

(xxi) 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).

(xxii) 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.

(xxiii) 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)

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 15 days prior to the expiration of the option period 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 contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

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):

https://www/ecfr.gov/ (under Title 48 Chapter 1) https://www.acquisition.gov/

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any Defense FAR Supplement (DFARS), (48 CFR 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232- 7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

Invoice and Receiving Report (COMBO)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer. N/A

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC HQ0672

Issue By DoDAAC W9114F

Admin DoDAAC** W9114F

Inspect By DoDAAC WK4FW0

Ship To Code WK4FW0

Ship From Code TBD

INSPECTOR Primary: SGT Rebecca Malpica rebecca.a.malpica.mil@mail.mil

Alternate: CPT David Boudreaux david.a.boudreaux9.mil@mail.mil

ACCEPTOR Primary: SGT Rebecca Malpica rebecca.a.malpica.mil@mail.mil

RECEIVING OFFICE POC: Primary: SGT Rebecca Malpica rebecca.a.malpica.mil@mail.mil

CONTRACT ADMINISTRATOR/ SPECIALIST: Donna Kabatek donna.m.kabatek.civ @mail.mil DSN: 314-590-6550 Commercial: +49-6371-9464-6550 Fax +49-6371-86-7900

CONTRACTING OFFICER: See Block 31b on SF1449 for email address.

ADDITIONAL CONTACT: MAJ Monika Yun-Thomas

Monika.M.Yun-Thomas.mil@mail.mil DSN: 314-590-5402

Modification requests must be in writing and submitted to:

Regional Health Contracting Office-Europe Bldg. 3705, Room 301, Attn: Contract Administrator 66849 Landstuhl Germany

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF point of contact.

Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS) DFAS Europe Attn: Rome, Kleber Kaserne (Block 18a of your purchase order/contract) at +49-631-411-6522/6523 or faxed to +49-631-411-6171. Please have your purchase order/contract number ready when calling about payments.

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

52.212-1 (Dev) Instructions to Offerors - Commercial Items. (DEVIATION

2018-O0018)

MAR 2020

ADDENDUM TO 52.212-1

Includes other provisions

52.204-7 System for Award Management OCT 2018 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.209-7 Information Regarding Responsibility Matters OCT 2018

CONTRACTOR ANSWERS

(b) The offeror ( ) has ( ) does not have current active Federal contracts and grants with total value greater than $10,000,000.

52.225-17 Evaluation of Foreign Currency Offers FEB 2000

SOURCE OF RATE

The source of the rate to be used is the approved Fiscal Year 2020 Budget Rate of EURO 0.8587 per 1.00 U.S.

Dollar.

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

CLAUSES INCORPORATED BY FULL TEXT

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://acquisition.gov/browse/index/far https://www/ecfr.gov/ (under Title 48 Chapter 1)

(End of provision)

52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (APR 1984)

(a) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of"(DEVIATION)" after the date of the provision.

(b) The use in this solicitation of any DoD FAR Supplement (DFARS) (48 CFR Chapter 2) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) Award will be made to the vendor providing the lowest-priced, technically acceptable quote for reagents to be used with an analyzer which meets or exceeds the requirements stated in the Salient Characteristics portion of the RFQ. Technical POCs for the Government will review the descriptive literature of any proposed analyzer to ensure it will adequately fulfill the Government’s needs as stated in the salient characteristics. Additionally, due to the nature of the requirement (cost per reportable test), any vendor providing a quote agrees to the service & maintenance requirements in said salient characteristics.

Since this is a competitive acquisition in accordance with FAR Parts 12 and 13.5 – Simplified Procedures for Certain Commercial Items, the Government will submit an offer in the form of a purchase order to the quoter representing the best value, as determined above, in response to this RFQ.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.217-5 EVALUATION OF OPTIONS (JUL 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

52.212-3 Alt I Offeror Representations and Certifications--Commercial

Items (MAR 2020) Alternate I

OCT 2014

REGARDING 52.212-3 ALT I

This provision, included here by reference IAW FAR 52.102(c), is accessible through and required to be completed in the System for Award Management (SAM) at https://www.sam.gov/SAM/ prior to submission of quote. Before accessing the provision at SAM for completion, it can be viewed in its entirety at https://www/ecfr.gov/ (under Title 48 Chapter 1) OR https://acquisition.gov/browse/index/far .