W9114F24R0003 Amendment 0006.pdf

W40M MRCO EUROPE

MEDICAL READINESS CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to do the follow ing:

a. Provide responses to questions received on 28 June 2024 and earlier.

b. Adjust PWS paragraph 5.2.1.3.3.

c. Change the solicitation response date/time to 26 July 2024 at 14:00 Central European Summer Time (CEST).

1. CONTRACT ID CODE PAGE OF PAGES

J 1 36

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 22-Jul-2024

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W9114F24R0003

X 9B. DATED (SEE ITEM 11)

20-Jun-2024

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

22-Jul-2024

CODE

W40M MRCO EUROPE

MEDICAL READINESS CONTR OFC EUROPE

CMR 402

APO AE 09180-0402

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W9114F

FACILITY CODECODE

EMAIL:TEL:

W9114F24R0003

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 25-Jul-2024 02:00 PM to 26-Jul-2024 02:00 PM.

The following have been added by full text:

Q&A, 2024.07.22

Page #/ Section

Reference Industry Question Government Answer

Page 54, Performance Work Statement Paragraph 5.2.1.3.3

The system shall include a digital microscopy component capable of detecting, differentiating, and quantifying cells, casts, crystals, and microorganisms in whole blood and body fluid samples.

Is it possible to offer for the digital microscopy component described in 5.2.1.3.3 a system that is only capable of whole blood analysis or is an analysis of body fluid samples mandatory?

Body fluid samples are not mandatory. PWS paragraph

5.2.1.3.3 has been adjusted to read as follows: "The system shall include a digital microscopy component capable of detecting, differentiating, and quantifying cells, and microorganisms in whole blood."

Page 54, Performance Work Statement Paragraph 5.2.1.3.3

The system shall include a digital microscopy component capable of detecting, differentiating, and quantifying cells, casts, crystals, and microorganisms in whole blood and body fluid samples.

Is the list of listed articles in

5.2.1.3.3 correct? Casts, crystals and microorganisms are common in urine samples but not in body fluids.

Casts and crystals are not required. Some micro-organisms are commonly reviewed in whole blood samples (ie. malaria, babesia). PWS paragraph

5.2.1.3.3 has been adjusted to read as follows: "The system shall include a digital microscopy component capable of detecting, differentiating, and quantifying cells, and microorganisms in whole blood."

Page 53, Performance Work Statement Paragraph 5.2.1.2.7

5.2.1.2.7 Each analyzer

shall provide at least 3 open channels to accommodate third party assays. These open channels shall be in excess of those required to fulfil PWS Paragraph

5.2.1.2.5 and PWS Paragraph 5.2.1.2.6.

Please explain in more detail which instruments are to be equipped with open channels.

Open channels are common in the field of clinical chemistry. In immunochemistry, it is not standard and uncommon.

Please confirm our acceptance.

In your case, all parameters in both areas can be mapped without open channels

In order to add additional testing in the future the lab requires to have open channels on all the analyzers that perform clinical chemistry and immunochemistry testing.

Page #/ Section

Reference Industry Question Government Answer

Page 59, Performance Work Statement Paragraph 5.2.4.7

5.2.4.7 The Contractor

shall provide an Inventory Program or System for continuous monitoring and management of all reagents, consumables and necessary supplies and their utilization, Please describe in detail what you mean by Inventory Program.

Do you want additional functionality that is not listed under 5.2.4.1, 5.2.4.2, 5.2.4.3, 5.2.4.4,.5.2.4.5, 5.2.4.6?

This does not have to be a computer program. An example is clear plastic shelves that hold reagent packs and make it easy for supply rotation and inventory monitoring. The lab requires a system to make supply inventory and management efficient.

Page 3, Item Description

ITEM 0001

Ordering Period; starting page 3 for all items:

a. Supplier/Services:

Ordering Period: 1 October 2024 through 31 August 2029

i. What is 1 October 2024 standing for? Starting point for installation? Starting point for shipments related to this contract?

1. this is in conflict to 52.216-18 “Such orders may be issued from 1 September 2024 through 31 August 2029.”

1 October 2024 is the date that orders can be placed for item 0001.

FAR clause 52.216-18 start date of 1 September 2024 covers any order placed for CLIN 0008 in September 2024.

Page 37, Performance Work Statement

Performance Work Statement, page 37

a. Total Laboratory Automation: 31 May

i. Should this be 31 May 2025? This date indicates the PWS version date.

(End of Q&A, 2024.07.22)

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Total Laboratory Automation 22 July 2024

Part 1 General Information

1. General: This is a supply contract under which the personnel rendering the services are not subject, either by contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1 Description of Supplies and Services/Introduction: This is a supply contract under FAR Parts 12 and 15 to provide Total Laboratory Automation testing capabilities for the Department of Pathology and Area Laboratory Services (DPALS) at the Landstuhl Regional Medical Center (LRMC) and to provide clinical chemistry testing capabilities for the laboratories at the SHAPE Army Health Clinic and the Grafenwoehr Army Health Clinic. The full delivery addresses are specified in PWS paragraph 5.2.8.7. Prices shall be fixed prices based on a Cost Per Reportable Result (CPRR) agreement, which shall include instrumentation, reagent packs, ancillary equipment, inventory management system (for all required supplies), water systems, middleware (hardware and software) including consulting and services required in developing, validating, and implementing features, maintenance, service, repairs, parts, labor, and materials required in order to keep the systems in optimum operating condition.

Installation and removal of equipment at all locations listed in the PWS shall also be included.

1.2 Background: This laboratory processes, analyzes, and produces clinically relevant reportable results for patient samples received at LRMC. Laboratory services are further extended to Department of Defense assets throughout Europe, the Middle East, and Africa that together encompass more than 200,000 beneficiaries. The requirements herein refine and improve the laboratory’s testing capacity by replacing existing capabilities with modern equipment commonly encountered in similarly sized hospitals and military medical centers.

1.3 Scope: The Contractor shall provide a total laboratory automation system (TLAS) with equipment and appropriate connections capable of clinical laboratory testing in chemistry, immunochemistry, hematology, coagulation, and serology, along with all necessary reagents, tools, materials, personnel training, auxiliary systems (e.g., water purification and uninterruptable power supplies, automatic refrigerated sample archiving, single-point remote access to TLAS-connected analyzers), and services necessary to meet the testing and analysis requirements for DPALS at LRMC. The Contractor shall provide equipment and appropriate connections capable of clinical laboratory testing in chemistry along with all necessary reagents, tools, materials, personnel training, auxiliary systems (e.g., water purification and uninterruptable power supplies), and services necessary to meet the testing and analysis requirements for laboratories at the Army Health Clinics at SHAPE and Grafenwoehr. The Contractor shall provide deliveries to the standards and acceptable quality levels identified in this PWS and associated contract documents.

1.3.1 All systems shall be capable of bidirectional network interface with the laboratory information system (LIS).

The LIS explicitly includes Military Health System (MHS) Genesis.

1.3.2 The chemistry analyzers at all sites shall be such that testing materials are interchangeable.

1.3.3 All equipment, methods and testing material (i.e., calibrators, controls, reagents, etc.) shall be U.S. Food and Drug Administration (FDA) approved.

1.3.4 All analyzers shall include all required peripherals (instrument specific computer terminals, CPUs, printers, etc.) and auxiliary systems (UPS, water purification, etc.).

1.3.5 All equipment requiring AC input shall be compatible with a 220VAC/50 Hz power grid.

1.3.6 The Contractor shall install and conduct initial method validations per Clinical Laboratory Improvement Amendments (CLIA), Clinical & Laboratory Standards Institute (CLSI), as outlined in the DPALS quality management guidelines as follows, method correlation, analytical measuring range, clinically reportable range, linearity verification to maximum dilution, precision, carry over, and normal reference range validation initially and with each new assay and/or conversion for each approved specimen type. The Contractor shall compile validation reports and present to DPALS for approval. The Contractor shall provide all reagents, calibrators, quality controls, and manpower to complete the installation and validation.

1.3.7 Equipment installation, method and network validation, and personnel training shall be completed within project timeline.

1.3.8 All reports, equipment displays, and supporting literature shall be in the English language.

1.3.9 The Contractor shall be responsible for maintenance service, on-site repair and parts as required to minimize equipment downtime. Downtime for all equipment and analyzers at each location shall not exceed 2 days per month.

The cumulative downtime for all equipment and analyzers at each location shall not exceed 7 days per year.

1.3.10 When necessary, the Contractor shall decontaminate and remove all instruments at the termination of the contract at no cost to the Government.

1.3.12 Equipment shall be new and not used or refurbished.

1.3.13 Shelf-life of reagents and quality control material:

1.3.13.1 Chemistry and immunochemistry reagents shall have a minimum shelf-life of six (6) months upon receipt by the Government.

1.3.13.2 Hematology, coagulation and serology reagents shall have a minimum shelf-life of three (3) months upon receipt by the Government.

1.3.13.3 Hematology quality control material shall have a minimum shelf-life of six (6) weeks upon receipt by the Government.

1.3.13.4 Other quality control material shall have a minimum shelf-life of three (3) months upon receipt by the Government.

1.4 Objectives: The objective of this contract is to provide:

1.4.1 Total Laboratory Automation testing capabilities at the LRMC as outlined in PWS paragraph 1.3.

1.4.2 Clinical chemistry testing capabilities at the SHAPE Army Health Clinic as outlined in PWS paragraph 1.3.

1.4.3 Clinical chemistry testing capabilities at the Grafenwoehr Army Health Clinic as outlined in PWS paragraph 1.3.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure supplies are delivered and services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the supplies are delivered, and work provided complies with the requirements of the contract.

The Contractor’s final QCP shall be submitted within 30 days after date of contract award (A.001).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor. If the Government has provided comments, the Contractor shall then submit a Final QCP. After receipt of the Final QCP, the Contractor may receive the Contracting Officer Representative’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the Contracting Officer Representative before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP shall include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team;

(b) How the Contractor shall monitor deliveries and work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);

(c) How the Contractor shall monitor deliveries and work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses;

(d) How the Contractor shall inventory and track maintenance of all Contractor Provided Equipment /

Materials (Make, Model, Part # and Serial Number);

(e) How the Contractor shall identify, investigate, and correct any non-conforming delivery or performance and prevent similar deficiencies in the future; and

(f) How the Contractor shall file and save all Quality Control related documents for the life of the contract until the contract is closed out.

1.5.1.1 RESERVED

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 24 hours of identifying those issues. Verbal reports shall be followed up by written reports within one business day.

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government will do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Supplies shall be delivered and work shall be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer Representative. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

New Year’s Day January 1st M. L. King Memorial Day 3rd Monday in Jan Presidents’ Day 3rd Monday in February Memorial Day last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

1.5.3.2 Host Nation Holidays: Supplies shall not be delivered and work shall not be performed on local Host Nation holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer Representative.

German national and local holidays are:

New Year’s Day January 1st Epiphany January 6th Good Friday Varies Easter Monday Varies Labor Day May 1st Ascension Day Varies Whit Monday Varies Corpus Christ Varies Assumption Day August 15th Day of German Unity October 3rd All Saints’ Day November 1st 1st Christmas December 25th 2nd Christmas December 26th

Belgian national holidays:

New Year's Day January 1st Easter Monday Varies Labor Day, May 1st Ascension Day Varies Whit Monday Varies Belgian National Day, July 21st Assumption Day August 15th All Saints' Day November 1st Armistice Day November 11th Christmas Day December 25th

1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are 0730 to 1600, Monday through Friday, excluding U.S. Federal Holidays.

1.5.4.2 Government Facility Operating Hours: The Government facility operating hours are 0000 to 2359, 365 days per year.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support between the hours of 0800 and 1600, Monday through Friday, excluding US and Host Nation Federal holidays. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.4.3.1 Contractor Work Plan: RESERVED.

1.5.5 Training Holidays: LRMC is a 24/7 operational hospital. The Contractor shall deliver supplies and provide services to the laboratory in accordance with PWS paragraph 1.5.4.3. However, unplanned closures due to unusual and compelling circumstances (e.g., natural disasters, military emergencies, severe weather), the Contractor shall not be required to deliver supplies and provide services.

1.5.6 Delivery Location Requirements: The supplies delivered and work to be performed under this contract will be at three locations specified in PWS paragraph 5.2.8.7

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: RESERVED.

1.6.2 Personnel Security Clearance Requirements: RESERVED.

1.6.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized by Host Nation law to work in that country. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S.

installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

1.6.3.1 Installation Pass Log: RESERVED.

1.6.3.2 Individual Termination or Expiration of Employment: RESERVED.

1.6.3.3 Contract Termination or Cancellation: RESERVED.

1.6.3.4 Common Access Cards (CAC) and CAC Log: RESERVED.

1.6.4 Background Checks: RESERVED.

1.6.4.1 U.S. Citizen: RESERVED.

1.6.4.2 Local Nationals and Third Country Nationals: RESERVED.

1.6.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured IAW the Army Physical Security Program (AR 190-13).

1.6.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel. Government issued access badges shall not be worn outside designated facilities where visible to the general public.

1.7 Key Control: RESERVED.

1.8 Meetings: The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.8.1 Periodic Progress Meetings: The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor’s performance. At these meetings the Contracting Officer Representative will apprise the Contractor of how the Government views the Contractor’s performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These periodic progress meetings shall be at no additional cost to the Government.

1.8.2. Post Award Conference: The Contractor shall attend post award conference convened by the Contracting Office in accordance with FAR Subpart 42.5. The Contractor shall provide deliverable A.002 Finalized Transition Plan at the converence.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work.

The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor’s performance and notifies both the Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: RESERVED.

1.11 Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties shall identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.12.1 RESERVED.

1.12.2 Contractor Identification Badges: RESERVED.

1.13 Contractor Travel: RESERVED.

1.14 Other Direct Costs (ODCs): RESERVED.

1.15 Data Rights: The Government has unlimited rights to all documents and data produced under this contract. All documents and data produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government.

These documents and data may not be used or sold by the Contractor without written permission from the Contracting Officer. This right does not abrogate any other Government rights.

1.16 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. The Contractor and Contractor personnel shall not divulge or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the Contracting Officer. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.17 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at http://www.dimoc.mil/resources/limitations/,the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.18 Non-Disclosure Statements: RESERVED.

1.19 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent OCI as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI (A.003). The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.20 Phase In /Phase Out Period: RESERVED.

1.21 Safety: The Contractor shall observe all biosafety guidelines in the Centers for Disease Control and Prevention’s, Biosafety in the Microbiological and Biomedical Laboratories, 6th Edition (https://www.cdc.gov/labs/BMBL.html).

1.22 Environmental Compliance: The following provides information on Environmental Compliance.

1.22.1 Environmental Compliance Plan and Program:

“The Contractor shall ensure that all of its operations and activities conform to the environmental policy requirements at the location of its work, namely Landstuhl Regional Medical Center, Grafenwoehr Army Health Clinic, and SHAPE Army Health Clinic. The Contractor shall ensure that all contract personnel have received appropriate levels of training in the handling, use, storage, and disposal of hazardous material. In addition, the Contractor shall ensure that all Contractor controlled activities at these locations are conducted in accordance with the governing Spill Prevention and Response Plan, Solid Waste Policy, Final Governing Standards-Germany or Belgium, and applicable German or Belgian environmental laws/standards.

If the Contract requires the use of hazardous materials/substances, the Contractor shall, prior to mobilization, inform the Contracting Officer (KO)/Contracting Officer Representative (COR) of the types and amount of hazardous materials needed to be brought onto the installation in order to fulfill their contractual requirements. The Contractor shall also provide the Safety Data Sheets, storage requirements and proposed storage locations for the hazardous material.

“Prior to contract completion, the Contractor shall remove all hazardous materials and dispose of all hazardous waste (HW) generated in accordance with Final Governing Standards Germany/Belgium and applicable German/Belgian environmental laws/standards. A copy of the HW disposal documents shall be forwarded to the HW program manager at the Department of Public Works (DPW) Environmental Division.

The Contractor shall clean up at its own expense any contamination, including soil and ground water contamination caused by hazardous materials/substances brought onto the garrison, or by his activities. The Contractor shall immediately report any hazardous substance spills to the Garrison Fire Department at CIV 0611-705-117.

The Contractor shall contact the COR for copies of the governing Environmental Policy, Spill Prevention and Response Red Plan, Solid Waste Policy and German/Belgian Final Governing Standards.

1.23 Required Training: The following provides information on training requirements.

1.23.1 Anti-Terrorism (AT) Level I Training: All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I Awareness training within 60 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 10 calendar days after completion of training by all employees and subcontractor personnel. AT level I Awareness training is available at the following website: http://jko.jten.mil.

1.23.2 OPSEC Training: RESERVED.

1.23.3 iWATCH Training: The contractor and all associated sub‐contractors shall brief all employees on the local iWATCH Army program (training standards provided by the requiring activity organizational antiterrorism officer).

This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 60 calendar days of contract award and within 60 calendar days of new employees commencing performance with the results reported to the COR NLT 60 calendar days after contract award.

1.23.4 Information Assurance (IA) Training: RESERVED.

1.23.4.1 RESERVED.

1.23.4.2 RESERVED.

1.23.4.3 RESERVED.

1.23.5 Personally Identifiable Information (PII): RESERVED.

1.24 Authorization to Perform Services in Germany:

1.24.1 Contractors performing services in the Federal Republic of Germany (FRG) shall comply with German law.

The Contractor shall determine whether performance requires registration with German authorities or authorization to do business in Germany and, if so, shall comply with all requirements. Whether or not registration or authorization to do business is required, the Contractor shall determine what documents or authorization its employees and any subcontractor employees shall possess to work in Germany. The Contractor shall ensure affirmatively that its employees and subcontractor employees possess such documents or authorizations.

1.24.2 Contractor employees who: (a) are not nationals of Germany or other European Union countries; (b) are not members of the force, the civilian component or their dependents; or c) do not have assimilated status under Articles 71, 72, or 73 of the Supplementary Agreement to the North Atlantic Treaty Organization Status of Forces Agreement shall possess work and residence permits.

1.24.3 By acceptance of and performance under this contract, the Contractor affirms that it has complied with the requirements above. Compliance with this requirement and German law is a material contract requirement.

Noncompliance by the Contractor or subcontractor at any tier shall be grounds for issuing a negative past performance evaluation and terminating this contract for default.

1.25 Authorization to Perform Services in Belgium:

1.25.1 Contractors performing services in the Kingdom of Belgium (KOB) shall comply with Belgian law. The Contractor shall determine whether performance requires registration with Belgian authorities or authorization to do business in Belgium and, if so, shall comply with all requirements. Whether or not registration or authorization to do business is required, the Contractor shall determine what documents or authorization its employees and any subcontractor employees shall possess to work in Belgium. The Contractor shall ensure affirmatively that its employees and subcontractor employees possess such documents or authorizations.

1.25.2 Contractor employees who: (a) are not nationals of Belgium or other European Union countries; (b) are not members of the force, the civilian component or their dependents; or c) do not have assimilated status under Articles 71, 72, or 73 of the Supplementary Agreement to the North Atlantic Treaty Organization Status of Forces Agreement shall possess work and residence permits.

1.26 Electromagnetic Compatibility Directive: The Contractor certifies that all electrical and electronic equipment and appliances furnished are in compliance with the Electromagnetic Compatibility Directive 2014/30/EU. For radio transmitting and telecommunication devices furnished in the FRG, the Contractor certifies that all such items have been approved by the Bundesamt fuer Zulassungen. Any penalties for noncompliance imposed by the Government of the European country where the equipment or appliances are delivered, or product liability claims caused by interference generated by furnished appliances or equipment are solely the responsibility of the Contractor.

1.27 Government Property and Services: RESERVED.

1.28 Conventional Forces Europe (CFE) Treaty Verification Inspection: Contractor-owned or controlled structures and containers located on U.S. Government installations are subject to short-notice inspections by CFE treaty inspection teams. The Government will endeavor to provide the Contractor as much notice as possible in the event of such inspections. The Contractor shall provide access to such structures and containers at the request of the Government. The Contractor shall report such inspections to the KO through the COR in writing within ten (10) calendar days of completion of the inspection. Contractor-owned or controlled structures and/or containers on U.S.

installations may have to be inspected to comply with the CFE treaty even if Contractor personnel are unavailable to provide access. Any costs borne by the Contractor or any impact on contract performance as a result of the inspection will be a matter of negotiation between the Contractor and the KO.

1.29 The Government will not sign any vendor-provided terms and conditions.

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart

202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, shall be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line-item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means a supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Cost Per Reportable Result (CPRR) – means a contractor provided price for a per patient reportable result. The per reportable result price shall include costs covering equipment use, all reagents, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor's equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the Government such as printer paper, labels etc. The per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by National Committee for Clinical Laboratory Standards (NCCLS). The per reportable result price shall also include all necessary maintenance to keep the equipment in good operating condition (This element includes preventive maintenance and emergency and routine repairs) and training for Government personnel. It also includes the delivery, installation and removal of equipment at no additional cost to the Government.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes Contractor-acquired property if the Contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract.

Government Property - means all property owned or leased by the Government. Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel;

to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Reportable result – means an instrument result verified by a laboratory technician that becomes part of a patient's electronic health record.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however, they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Workday - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

ACOR Alternate Contracting Officer's Representative AE Army in Europe

AFARS Army Federal Acquisition Regulation Supplement AHA Activity Hazard Analysis AOR Area of Responsibility AQL Acceptable Quality Level AR Army Regulation AT Anti-terrorism ATCTS Army Training Certification Tracking System ATO Authority to Operate CAC Common Access Card CAP College of American Pathologists CCE Contracting Center of Excellence CFE Conventional Forces Europe CFR Code of Federal Regulations CLIA Clinical Laboratory Improvement Amendments CLSI Clinical & Laboratory Standards Institute CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTS Commercial-Off-the-Shelf DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DHA Defense Health Agency DPALS Department of Pathology and Area Laboratory Services DoD Department of Defense FAR Federal Acquisition Regulation FRG Federal Republic of Germany GFP Government Furnished Property HLO High Level Objective HIPAA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness IAC Installation Access Control IACO Installation Access Control Office ID Identification IGCE Independent Government Cost Estimate IS Information System IT Information Technology JTR Joint Travel Regulation JPAS Joint Personnel Adjudication System KO Contracting Officer LIS Laboratory Information System LRMC Landstuhl Regional Medical Center MHS Military Health System OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPSEC Operations Security PA Property Administrator PII Personally Identifiable Information PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance

QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RA Requiring Activity RCO Regional Contracting Office RMF Risk Management Framework SAPR Sexual Assault and Response Program SHAPE Supreme Headquarters Allied Powers Europe SIGE Safety and Health Protection Plan STD Standard TE Technical Exhibit TLAS Total Laboratory Automation System USAG United States Army Garrison USAREUR United States Army Europe UOM Unit of Measure

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: RESERVED.

3.2 Facilities: The Contractor shall provide facilities for all offsite training outlined in 5.2.6.

3.3 Utilities: RESERVED.

3.4 Equipment: RESERVED.

3.5 Special Tooling and Test Equipment: RESERVED.

3.6 Materials: RESERVED.

3.7 Training: RESERVED.

3.8 Common Access Cards (CAC)/Installation Access: No CAC will be issued to the Contractor. The Contractor shall not be provided uncontrolled access to the installations or labs. The Contractor shall work with the lab to gain access to installations and labs.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide supplies and perform services as described in the PWS and associated contract documents, except for those items specified in Part 3 Government Property and Services.

4.2 Secret Facility Clearance: RESERVED.

4.3 Materials: The Contractor shall provide all quality control testing material, reagents, and calibrators required for performance verification/validation of each method and analyzer it installs.

4.4 Vehicles and Equipment: The Contractor shall provide all necessary vehicles needed to install all equipment items in their final destination. This includes vehicles and equipment required for indoor transport such as pallet jacks.

4.5 Background Checks: RESERVED.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide, install, maintain and repair equipment in accordance with PWS paragraph 1.1.

5.2 Tasks: Tasks consist of the following:

5.2.1 Total Laboratory Automation at LRMC. All primary and support equipment outlined in this section shall fit within a space of 120.40 square…