W9114F22Q0023-0001 released amendment to correct PWS.pdf

W9114F22Q0023

0011715052-0001

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 the amendment is to correct the PWS and extend the closing date.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 37

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

16C. DATE SIGNED

BY 15-Mar-2022

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 W9114F22Q0023

X 9B. DATED (SEE ITEM 11)

07-Mar-2022

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

15-Mar-2022

CODE

W40M EUR REGIONAL CONTRACT OFC

KIRCHBERG KASERNE

BUILDING 3705

LANDSTUHL 66849

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

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

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 16-Mar-2022 12:00 AM to 21-Mar-2022 04:00 PM.

The following have been added by full text:

PERFORMANCE WORK STATEMENT

Title: Laboratory Accreditation in accordance with ISO/IEC 17025:2017, TNI Standards 2016, or current versions as updated, and other accreditations/certifications as needed to support mission.

Requiring Activity Name: United States Army Medical

Command (MEDCOM), Regional Health Command Europe (RHCE), Public Health Command Europe

(PHCE)

1. INTRODUCTION

The US Army Public Health Command Europe (PHCE) contains a Public Health Laboratory Division (Laboratory Sciences or LS) that supports Department of Defense (DoD) and other customers throughout the United States Army Europe and Africa (EUCOM/AFRICOM) theatre. LS provides scientifically sound and defensible quality analytical data for samples submitted by its customers. The results are used by decision makers whose objectives include ensuring regulatory compliance, effectiveness of force health protection measures, and Army readiness for all missions.

2. PURPOSE AND BACKGROUND

When customers are selecting a laboratory to fulfil testing needs, that lab must be able to provide accurate and reliable results. The technical competence of a laboratory depends on a number of factors including qualifications and training, proper instrumentation, adequate quality assurance and oversight, proper sampling guidance, appropriate testing methods, traceability of measurements to national institutes, accurate recordkeeping, and suitable testing facilities.

In addition, accreditation reduces risk for a laboratory and its customers by assuring that accredited laboratory is competent to carry out the work they undertake within its scope of accreditation. Further, the results from accredited facilities are used extensively by regulators for the public benefit in the provision of all LS core mission services that promote military health such as an unpolluted environment, safe food, clean water, and other health services.

Accrediting bodies that are members of International Laboratory Accreditation Cooperation (ILAC) and the Conformity Assessment Bodies (CABs), i.e., laboratories, they accredit are required to comply with appropriate international standards and the applicable ILAC application documents for the consistent application of those standards. The International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) links the existing regional MRAs/MLAs of the Recognized Regional Cooperation Bodies. ILAC is the international organization for accreditation bodies operating in accordance with ISO/IEC 17011 and involved in the accreditation of conformity assessment bodies including calibration laboratories (using ISO/IEC 17025), testing laboratories (using ISO/IEC 17025). PHCE LS is seeking to renew its laboratory accreditation to ISO/IEC 17025:2017 which must comply with a comprehensive list of standards and requirements as specified under nationally and internationally recognized accepted criteria for competence. This accreditation supports PHCE LS as the choice provider of analytical testing services in the theatre by its customers.

3. SCOPE

In order to be considered for award, the Contractor (Accrediting Body or AB) shall be required to communicate using English language and possess, maintain, or provide the following capabilities:

Possess and maintain international recognition by the International Laboratory Accreditation Cooperation (ILAC) and/or the applicable regional accreditation group under a Mutual Recognition Arrangement (MRA), according to ISO/IEC 17011 requirements;

Possess and provide a current existing certificate and/or scope that confirms that the Contractor is authorized to accredit conformity assessment bodies (CABs), i.e., laboratories to ISO/IEC 17025:2017; Possess and provide current versions of conditions and requirements of accreditation documents; Possess and maintain the ability to accredit various matrices to include air, wipes, drinking water, non- potable water, environmental, tissue, arthropods, soil, sediment, food, and clinical and veterinary specimens;

Possess and maintain the ability to accredit not only published methods, but also laboratory developed methods that meet validation and strict quality control requirements of the Contractor;

Posses and maintain technical knowledge and experience in chemical and biological analyses of applicable matricies;

Posses and maintain the ability to provide either a flexible scope of accreditation or the ability to accommodate frequent changes to a fixed scope of accreditation as the mission requires

4. PERIOD OF PERFORMANCE

This contract is for one (1) twelve (12) month Base Period and four (4) twelve (12) month option periods. The periods of performance for this contract are as follows:

Base period 31 March 2022 – 30 March 2023 Option period 1 31 March 2023 – 30 March 2024 Option period 2 31 March 2024 – 30 March 2025 Option period 3 31 March 2025 – 30 March 2026 Option period 4 31 March 2026 – 30 March 2027

5. WORK SCHEDULE AND LOCATION

The Contractor shall work at their facility and at the location of Public Health Command Europe for the onsite assessment requirement.

5.1. Work Location

The locations of the Public Health Lab are as follows:

Public Health Command Europe, Laboratory Sciences, Bldg.

3809, 3810

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The objective of this requirement is to provide formal recognition of accreditation IAW standard Contractor requirements for the methods used by PHCE LS as required by this Performance Work Statement (PWS).

6.2. Specific Tasks/Requirements

6.2.1 Task 1 – Accept all current internationally recognized Scopes of Accreditation (Attachment 3) for PHCE LS to include any granted extensions.

6.2.2 Task 2 – Assessment of the laboratories by mutually agreeable Subject Matter Experts (SME) for that laboratory’s particular field of testing using appropriate comprehensive checklists developed by the Contractor. This shall be performed on-site or remotely, if necessary, by the assigned assessor(s). During a national emergency/pandemic when the Contractor cannot access Government facilities an alternative method for assessment will be executed using remote capability resources. When restrictions have been lifted the Contractor will resume on-site tasks.

Remote assessments may occur as mutually agreed via telephone or virtual meetings. An on-site assessment to confirm technical competence may follow as soon as travel restrictions have been lifted if deemed necessary by the Contractor based on the outcome of the remote assessment.

6.2.3 Task 3 – Provide a final detailed written report (Deliverable 1) to the respective Laboratory Director, Quality

Assurance Officer, and Contracting Officer’s Representative (COR) within 30 calendar days of completion. PHCE LS is responsible for identifying these authorized officials to the Contractor.

6.2.4 Task 4 – Provide formal recognition of accreditation via letterhead certificate(s) and scope(s) of accreditation listing all accredited technologies/methodologies (Deliverable 2 and 3) as soon as all Contractor accreditation requirements have been met by PHCE LS including providing objective evidence of any necessary corrective actions.

6.2.5 Task 5 – Use the schedule in Attachment 2 that details accreditation, last onsite assessment, and next required assessment.

6.3. Management Reports and Plans

6.3.1 Quality Control Plan (Deliverable 3). The Contractor shall provide a draft Quality Control

Plan (QCP) no later than 15 calendar days after contract award. The Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the Contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction. The Contractor may use or reference copies of existing policies and procedures the Contractor has in place that meet the same purpose.

7. DELIVERABLES

The Contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

6.2.1.4 Deliverable 1 Final Assessment Report. Provide a detailed final assessment report to the Laboratory Director, Quality Assurance Officer, and COR following each assessment.

30 Calendar Days after each assessment completion

6.2.1.4 Deliverable 2 Certificates of Accreditation 30 Calendar Days after all Contractor accreditation requirements are met by PHCE LS

6.2.1.4 Deliverable 3 Scopes of Accreditation 30 Calendar Days after all Contractor accreditation requirements are met by PHCE LS

9.2 Deliverable 4 Travel Cost Estimate No later than (NLT) 30 days prior to travel

9.2 Deliverable 5 Travel Voucher Within 30 days of

travel

14.10.1 Deliverable 6 Anti-Terrorism Level I (AT Level I) Certificate 30 calendar days after completion of training

14.10.4 Deliverable 7 iWATCH Training Within 30 calendar

days of contract award and within 15 calendar days of new employees commencing performance, with the results reported to the COR NLT 45 calendar days after contract award.

14.10.5 Deliverable 8 Level I OPSEC Awareness training. within 30 calendar days of their reporting for duty and annually thereafter.

14.11 Deliverable 9 Sexual Harassment/Assault Response and

Prevention (SHARP) Certificate

60 days after contract award

14.13 Deliverable

Health Insurance Portability and Accountability Act (HIPPA) Certificate

60 days after contract award

14.17 Deliverable

OSHA Form 300A February 1 of each year

7.1. Reports and Documents

Reports and documents delivered by the Contractor in the performance of this contract shall be considered Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the Contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

7.2 Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsibilities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the PWS and all terms and conditions of this order, including all modifications.

7.3 COR Information

TBD at time of award.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives (see Attachment 4). The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the Contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the Contractor.

The Contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

9. TRAVEL/TEMPORY DUTY (TDY)

The COR is the OCONUS (Outside the Continental United States) travel order approval authority as designated in writing by the Contracting Officer (KO). All OCONUS travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the COR and is on a strictly cost reimbursable basis. The Contractor shall be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs, subject to local policy and procedures.

9.1 Travel Arrangements

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than 30 calendar days prior to scheduled OCONUS travel date, the Contractor will prepare the estimate in an official memorandum format. The estimate shall include airline ticket costs, car rental, per diem, registration fees and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel. The COR will provide the Contractor a signed approval of Government Contractor Official Travel Letter of Identification before the Contractor is authorized to travel either OCONUS. Estimated travel is based on the locations of PHCE LS. It is dependent on the starting location of each assessment.

9.2 Travel Claim Procedures, Approval, and Reimbursement

Travel shall be reimbursed after the KO has determined fair and reasonable cost reimbursement IAW the JTR and FAR Part 31.205-46. The Contractor shall submit an estimate for travel to COR no later than 30 calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost (Deliverable 4).

The COR will verify the travel receipts are valid and match the travel requirements identified in the PWS. The Contractor shall provide a trip report (Deliverable 5) to include costs associated with the travel to the COR within ten (10) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by COR or KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items in excess of $75.00.

9.3 DOD Contractor Foreign Travel/OCONUS

Approval of Foreign Travel. Foreign travel under this contract is defined as any travel outside of the continental United States and its territories and possessions. The cost of foreign travel is allowable only when specific written approval of the Contracting Officer is obtained prior to the commencement of the travel. This is a requirement for all DoD Contractors traveling on official DoD business.

9.3.1 The following requirements for DoD-sponsored Contractors will be accomplished by the Contractor(s) prior to foreign travel on approval of the Contracting Officer. Allow 90 days for completion of training requirements and approval of the application process. Consult the DoD Foreign Clearance Guide at https://www.fcg.pentagon.mil.

9.3.2 Mandatory training and minimum requirements must be met and a copy provided to the contracting officer at least fifteen (15) days prior to scheduled departure.

9.3.3 Costs incurred by Contractor personnel on official company business, whether foreign travel and/or domestic/local travel, are allowable subject to the limitations in the Federal Acquisition Regulation (FAR clause

52.216 - 7 Allowable Cost and Payment); incorporated into this contract.

9.3.4 MANDATORY TRAINING – OFFICIAL GOVERNMENT TRAVEL

Anti-Terrorism Level 1 (valid for one year) Area of responsibility briefing completed within three months of travel.

9.3.4 TRAINING LINKS

Anti-Terrorism Level 1-https://atlevel1.dtic.mil/at/.

10. GOVERNMENT FURNISHED PROPERTY

The Government will not furnish any property in support of this contract requirement.

11. CONTRACT MANAGEMENT

11.1 Government Management

The KO will appoint a COR to be the Government’s authorized point of contact (POC). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

11.2 Contractor Management

The Contractor shall appoint a Program Manager (PM) to be the Contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning Contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends http://www.fcg.pentagon.mil/ relating to the contract, or proposed changes or modifications to the contract.

11.3 Contractor Organization

The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The Contractor shall ensure that all Contractor personnel are advised of their chain of command and who they should contact if they have questions.

12. COMPLIANCE DOCUMENTS

12.1 General Compliance

12.1.1 Federal Law

The services provided under this contract must be conducted in accordance with all applicable Federal law and Department of Defense (DOD), Department of the Army (DA), and US Army Medical Command (MEDCOM) command regulations, policies, and procedures.

12.1.2 Occupational Safety and Health Administration

The Contractor shall comply with Occupational Safety and health Administration Standard Number

1904.32. The Contractor shall deliver the 300A by February 1 of each year (Deliverable 11).

12.1.3 DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards,or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program.

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology.

http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For

DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf http://www.dtic.mil/whs/directives/corres/dir.html http://www.dtic.mil/whs/directives/corres/dir.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

e) Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

f) ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

g) Title 21, CFR Part 11 Electronic Records: Electronic Signature.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

12.2 Medical and Laboratory Compliance

12.2.1 Army Regulation 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at:

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

12.2.3 DOD Health Information Privacy

Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

12.2.4 Laboratory Requirements

Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

13. REFERENCE DOCUMENTS

a) Department of Defense Instruction 6440.02, Clinical Laboratory Improvement Program (CLIP) Manual, May

29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf

b) US Medical Entrance Processing Command Regulation 40-1, Medical Processing and Examinations http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

14. OTHER TERMS, CONDITIONS, AND PROVISIONS

14.1 Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise Contractor personnel nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual Contractor personnel. It shall be the responsibility of the Contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the Contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor's responsibility to notify the Contractor Officer (KO) immediately.

14.2 Severable/Non-Severable Services

This award identifies services that are severable in nature.

14.3 Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

14.4 Acquisition Functions Closely Associated with Inherently Governmental Functions http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://www.gpo.gov/fdsys/granule/CFR-2011-http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&amp%3Bsort=pubNo http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&amp%3Bsort=pubNo

This requirement has been reviewed and contains no services that are closely associated with inherently governmental functions.

14.5 Organizational Conflict of Interest

U.S. Army Public Health Center (PHCE) has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding, or mitigating Organizational Conflicts of Interest (OCI) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other Contractors’ proprietary information, or put the Contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist PHCE in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

13.5.1 OCI Certification. PHCE OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the PHCE organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan. The Contractor shall complete the OCI Certification at time of proposal submission.

14.6 Invoices

The Contractor shall submit invoices monthly to Wide Area Work Flow (WAWF), or current system, with sufficient documentation to provide certification of invoice.

The Contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The Contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, Contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

14.7 Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

14.8 Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

14.9 Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their Contractor status known during introductions.

14.10 Anti-Terrorism and Operational Security

14.10.1 AT Level I Training (Deliverable 6)

All Contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 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 30 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.

14.10.2 Access and general protection/security policy and procedures.

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204- 9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

a) For Contractors that do not require CAC, but require access to a DoD facility or installation.

Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forcesagreements and other theater regulations.

14.10.3 AT Awareness Training for Contractor Personnel Traveling Overseas.

This standard language requires U.S.-based Contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR)–specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

http://jko.jten.mil/

14.10.4 iWATCH Training. This standard language is for Contractor employees with an area of performance within an Army-controlled installation, facility, or area (Deliverable 7).

The Contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally 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 30 calendar days of contract award and within 15 calendar days of new employees commencing performance, with the results reported to the COR NLT 45 calendar days after contract award.

14.10.5 For Contracts That Require OPSEC Training (Deliverable 8).

Per AR 530-1, Operations Security, the Contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

14.10.6 For Contract Requiring Performance or Delivery in a Foreign Country.

DFARS Clause 252.225-7043, Antiterrorism/Force Protection for Defense Contractors Outside the US, shall be used in solicitations and contracts that require performance or delivery in a foreign country. This clause applies to both contingencies and non-contingency support. The key AT requirement is for non-local national Contractor personnel to comply with theater clearance requirements and allows the combatant commander to exercise oversight to ensure the Contractor’s compliance with combatant commander and subordinate task force commander policies and directives.

14.11 Sexual Harassment/Assault Response and Prevention (SHARP) (Deliverable 9)

The Contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by Contractor personnel while performing services under this contract.

The Contractor shall require all Contractor personnel with knowledge of an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the Contractor is providing services under this contract, to report the incident to the Contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR or Contracting Officer. All incidents shall be reported whether they involve Contractor personnel or Government personnel, or other individuals.

The Contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after Contractor personnel begin performance under this contract and annually thereafter. Training can be self study using the attached slides, obtained online for Contractor personnel with an Army Knowledge On-line (AKO) account or in person. In-person training through USAMRAA can be scheduled by contacting 301-619-8937 for class date/time and availability. If the employee has an AKO account, they can access training online at Army AKO https://www.us.army.mil/. Once in AKO:

Under the "Self Service" tab, click on "My Training"; once that page comes up, in the center of the page, click on the ALMS logo or the "Access the ALMS" option. On the left hand side of the page that launches, click on “Search”, and enter “SHARP Standing Strong” in the Search option (in about the middle of the page that opens). Sexual Harassment/Assault Response and Prevention Standing Strong Training (Version:

FY15) will appear as one of your options. Under that option, click on the “Begin Registration” option.

14.12 Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

http://www.us.army.mil/

The Contractor shall comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g. Public Affairs clearance and Operational Security clearance for dissemination).

14.13 Personally Identifiable Information (PII) and Protected Health Information (PHI) (Deliverable 10)

The Contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The Contractor may access PII in the course of task response to the requirements of this contract, as such the Contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The Contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference(aa)), DoD 5400.11 (Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter36 of Title 44, U.S.C. (Reference (ae)).

The Contractor shall ensure all service providers receive Health Insurance Portability and Accountability Act (HIPPA) training not later than 60 calendar days after Contractor personnel begin performance under this contract and annually thereafter. Training can be self-study using the attached slides, obtained online for Contractor personnel with an Army Knowledge On-line (AKO) account or in person. In-person training through USAMRAA can be scheduled by contacting 301-619-8937 for class date/time and availability. If the employee has an AKO account, they can access training online at Army AKO https://www.us.army.mil/. Once in AKO:

Under the "Self Service" tab, click on "My Training"; once that page comes up, in the center of the page, click on the ALMS logo or the "Access the ALMS" option. On the left hand side of the page that launches, click on “Search”, and enter “HIPPA” in the Search option (in about the middle of the page that opens).

HIPAA and Privacy Act Training will appear as one of your options. Under that option, click on the “Begin Registration” option.

14.15 Workplace Safety

The Contractor employee must be able to maintain a safe workplace and comply with occupational health and safety rules and regulations. Contractor employees are required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the COR immediately.

14.16 Occupational Health

The Contractor will be required to ensure compliance with Occupational Health physicals or vaccinations in support of the PWS. These shall be documented and charged as an ODC.

14.17 OSHA Contractor Requirements (Deliverable 11)

http://www.us.army.mil/

The Contractor shall maintain an OSHA 300A log for all reportables (greater than first aid, lost time, lost days, transfer). The Contractor shall provide a quarterly report of all mishaps, regardless of class or reportability.

Annually, the Contractor shall provide a 300A (summary) report to the COR and KO.

15. ATTACHMENTS

Attachment 1 – Organizational Conflict of Interest Attachment 2 – Schedule of Assessments Attachment 3– The PHCE LS (Landstuhl, Germany) Scopes of Accreditation Attachment 4 – Quality Assurance Surveillance Plan (QASP)

16. ACRONYMS LIST

Acronym Definition AFARS Army Federal Acquisition Regulation Supplement

AKO Army Knowledge Online AOR Area Of Responsibility

AT OPSEC Antiterrorism and Operational Security ATCTS Army Training Certification Tracking System CAC Common Access Card

CFR Code of Federal Regulations CONUS Continental United States

COR Contracting Officer Representative DFARS Defense Federal Acquisition Regulation Supplement

DoD Department of Defense EIT Electronic and Information Technology FAR Federal Acquisition Regulation FBI Federal Bureau of Information

FPCON Force Protection Condition FSC Federal Supply Code FSS Federal Supply Schedule GFE Government Furnished Equipment GFI Government Furnished Information GSA General Services Administration IA Information Assurance ID Identification

ID/IQ Indefinite Delivery / Indefinite Quantity IPT Integrated Product/Process Team IT Information Technology

NAC National Agency Check NACI National Agency Check with Inquiries

NCIC-III National Crime Information Center Interstate Identification Index NLT No Later Thank OCI Organizational Conflict of Interest

OCONUS Outside Continental United States OPSEC Operational Security PMO Project Management Office PRS Performance Requirements Summary PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan QCP Quality Control Plan

SHARP Sexual Assault Prevention and Response Program SOP Standing Operating Procedure

TARP Threat Awareness and Reporting Program U.S.C. United States Code UIC Unit Identification Code US United States

USAMRAA United States Army Medical Research Acquisitions Activity WAWF Wide Area Work Flow

ATTACHMENT 1: ORGANIZATIONAL CONFLICT OF INTEREST

The PHCE has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interests (OCI) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other Contractors’ proprietary information, or put the Contractor in a position to influence the award decision on a contract in which they are participating.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist PHCE in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that PHCE presumes that award of a contract or order in the subject category will give rise to real or apparent OCIs with respect to requirements in the other two categories; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in PHCE requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all PHCE requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying, avoiding and/or mitigating against OCIs, PHCE will examine all its non-purchased care requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each PHCE non-purchased care solicitation will therefore be designated as falling within one of the three above defined categories. The work called for under this contract / order has been determined by PHCE to fall within the following non-purchased care OCI category:

Category 2: Program Management Support

PHCE will administer this clause for purposes of award eligibility for each solicitation as follows:

An Offeror that has never provided support to PHCE in any of the categories is eligible for award in any category without any further action required under this clause.

An Offeror that provides or has provided support to PHCE in only one category of work and has never supported PHCE in any other category (a single-category Contractor) is eligible for award for any future requirementin that single category without further action under this clause.

A single-category Offeror/Contractor wishing to submit an offer in a different category, or any Offeror/Contractor which now provides or previously has provided support in more than one category, must include the following as part of its offer:

• Perform a comparative analysis of the potential new work against all current and previous work performed in support of PHCE in any category other than that of the new work being offered. The comparative analysis must be included in the proposal for the new work, and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI. If the Contractor believes that no real or perceived OCI will result from an award of the proposed work, no additional action by the Contractor is required.

• If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award,the

Contractor shall also submit an OCI Avoidance or Mitigation Plan with its proposal.

Inclus…