B08. PWS - Water for Injection System Maintenance as of 03.18.2025.pdf

JUN 22

PERFORMANCE WORK STATEMENT (PWS)

Water for Injection/Pure Steam Generation and Distribution Systems Maintenance for the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF)

PART 1

GENERAL INFORMATION

1. General: This is a non-personal services contract under which the personnel rendering the services are not subject, either by the contract’s 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 Services/Introduction: This is a non-personal services contract to provide water for injection/pure steam generation and distribution systems maintenance.

1.2 Background: Since 1893, the Walter Reed Army Institute of Research (WRAIR) has been a leader in solving the most significant threats to Soldier readiness and lethality such as disease and battle injury. WRAIR’s broad research capabilities afford Soldiers the best medical protection and support possible before, during, and after deployment by addressing both longstanding and emerging threats. Though WRAIR’s research is focused on Soldier health, its products have important civilian applications, saving countless lives around the world.

WRAIR’s Center for Enabling Capabilities (CEC) facilitates the execution of innovative military relevant medical research protecting and optimizing performance of the Warfighter. The mission of WRAIR’s CEC is to advance medical capability and countermeasure development through provision of world class, cost efficient, and professional research support.

The Pilot Bioproduction Facility (PBF) within the CEC conducts research, development, production, and testing of vaccines and other biological products. The PBF is a Current Good Manufacturing Practice (CGMP)-compliant pharmaceutical manufacturing facility that specializes in developing vaccines and biologics for military-relevant infectious disease threats.

PBF capabilities include process development, scale-up, and CGMP drug substance and drug product manufacturing. PBF support has been critical to the Department of Defense’s (DoD’s) development efforts in the advancement of numerous vaccines. These vaccines include those for hepatitis A, meningitis, dengue fever, malaria, adenovirus, Japanese encephalitis, shigellosis, zika, and, most recently Covid-19. Conventional as well as recombinant and other genetically engineered vaccines are undergoing development and production at WRAIR. Other types of biological products (e.g., therapeutics) are also capable of being produced under the right circumstances.

1.3 Scope/Period of Performance (PoP):

1.3.1 Scope: The contractor shall provide non-personal services. This shall include providing all necessary personnel, equipment, supplies, transportation, tools, materials, supervision, and other items necessary to perform services as described in this Performance Work Statement (PWS), and associated contract documents, except for those items specified in Part 3 Government Property and Services. The contractor shall perform to the standards and Acceptable Quality Levels (AQLs) identified in this PWS and associated contract documents.

1.3.2 Period of Performance (PoP): The anticipated PoP for this requirement is as follows:

Base Period 04 May 2025 – 03 May 2026 Option Period 1 04 May 2026 – 03 May 2027 Option Period 2 04 May 2027 – 03 May 2028 Option Period 3 04 May 2028 – 03 May 2029 Option Period 4 04 May 2029 – 03 May 2030

1.4 Objectives: The objective of this contract is to perform preventative maintenance (quarterly, semiannual, and annual), calibration, five-year overhaul, and emergency service, including all materials and supplies required to complete maintenance and repairs, for the continued operation of water for injection/pure steam generation and distribution systems (Original Equipment Manufacturer (OEM): MECO) installed and used within the WRAIR, PBF to supply process water to autoclaves, fermenters, various other equipment, and manual use points as well as pure steam for sterilization in support of CGMP.

A multiple effect distillation unit (MECO 3ME10, Serial Number (SN): 9805) is installed that vaporizes reverse osmosis/deionized type II laboratory water. Water for injection is condensed from the pure steam output of up to three multiple effect distillation columns, which is then sent to a water for injection storage tank. The contents of the storage tank are then circulated by the water for injection distribution pumping system (MECO SN: 9806). This system includes a cooled circulation section of piping and a heated circulation section. Upon return to the storage tank, all water is reheated and injected back into the water for injection tank. A fraction of the pure steam generated by the columns is not condensed and is instead sent to the pure steam distribution system. This system supplies autoclaves, fermenters, various other equipment, and manual use points within the PBF with pure steam for sterilization.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The contractor’s existing quality assurance system shall be utilized in accordance with Federal Acquisition Regulation (FAR) 12.208; Contract quality assurance.

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 must 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 AQLs/performance thresholds.

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of this 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: Work shall not be performed on United States (U.S.) federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer (KO). When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

o New Year’s Day: January 1st o Martin Luther King Jr. Day: 3rd Monday in January o President’s Day: 3rd Monday in February o Memorial Day: Last Monday in May o Juneteenth National Independence Day: June 19th o Independence Day: July 4th o Labor Day: 1st Monday in September o Indigenous Peoples Day: 2nd Monday in October o Veteran’s Day: November 11th o Thanksgiving Day: 4th Thursday in November o Christmas Day: December 25th

1.5.3.2 Host Nation Holidays: RESERVED.

1.5.4 Operating Hours: The Government facility office hours, Government 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 occur between the hours of 0600 and 1700 Eastern Standard Time (EST), Monday through Friday, except U.S. holidays identified in paragraph 1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2 Government Facility Operating Hours: The Government facility operating hours occur between the hours of 0600 and 1800 EST, Monday through Saturday. The Government facility may close due to local or national emergencies, administrative closings, or national holidays identified in paragraph 1.5.3.1 above.

1.5.4.3 Contractor Support Hours: Typically, the contractor shall provide support between the hours of 0600 – 1800 EST; however, the contractor may perform work outside of normal Government facility operating hours to minimize system downtime or in the event of an emergency (e.g., system incurs a failure mode). The contractor shall maintain an adequate workforce at all times to execute uninterrupted performance of all tasks defined within this

PWS. 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: The contractor shall prepare and maintain a work plan.

The plan, as a minimum, shall identify regularly scheduled work to include location, work to be completed, timeline, etc. The contractor’s proposed work plan shall be submitted to the KO via the Contracting Officer’s Representative (COR) for review within 10 days after contract award.

The Government will review and either accept or return their comments to the contractor within 10 days. The contractor shall then have three days to submit a final work plan. Any proposed change to the accepted final work plan is required to be resubmitted via the COR for review and acceptance by the KO at least 30 days prior to implementation. The timeline noted above shall apply for review and acceptance for proposed changes (A.001).

1.5.5 Training Holidays: WRAIR has historically granted military personnel training holidays as compensation for time that they spent in field training. These are typically combined with regular holiday leave schedules (e.g., Christmas half-days or day-on/day-off schedules). Training holidays may affect access to military operated facilities. If scheduled work or access to facilities is required, coordination with occupants will be necessary or the work in affected facilities shall be rescheduled to take place before or after the training holiday.

However, announced training holidays or exodus of military personnel may provide the contractor with an opportunity for unrestricted access to facilities and areas. The contractor shall take full advantage of such opportunities by planning scheduled maintenance and other actions that are better accomplished when such areas are vacant.

1.6 Place of Performance: The work to be performed under this contract will take place on-site at WRAIR: 501 Robert Grant Avenue, Silver Spring, Maryland, 20910, where the water for injection/pure steam distribution systems are installed.

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

1.7.1 Security Program: The contractor does not require facility or personnel security clearance; however, contractors may require a Public Trust determination.

1.7.2 Personnel Security Clearance Requirements: The contractor does not require personnel security clearance; however, contractors shall comply with standard WRAIR post requirements.

1.7.2.1 Handling of or Access to Classified Information: RESERVED.

1.7.2.2 Controlled Unclassified Information (CUI): RESERVED.

1.7.3 Installation Access: Access to U.S. installations, buildings, and controlled areas is limited to personnel who meet security criteria and are authorized. 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 comply 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 (IAC). The Government is not liable for any costs associated with performance delays due solely to a contractor’s failure to comply with IAC system processing requirements.

The contractor shall return installation passes to the issuing IAC office when the contract is completed or when a contractor employee no longer requires access (A.002).

1.7.3.1 Installation Pass Log: RESERVED.

1.7.3.2 Individual Termination or Expiration of Employment: The contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within five days (A.002).

1.7.3.3 Contract Termination or Cancellation: Upon termination or cancellation of this contract, the contractor shall collect all outstanding installation access passes and return them to the issuing office within five days (A.002).

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

1.7.3.4.1 Contractors Requiring a Common Access Card (CAC): RESERVED.

1.7.3.5 Contractors That Do Not Require a Common Access Card (CAC), But Require Access To A Department of Defense (DoD) Facility or Installation: The 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 (TSDB); applicable installation, facility, and area commander installation/facility access; and local security policies and procedures (provided by Government representative).

1.7.3.5.1 Non-Escort/Escorted Badge: Non-escort/escorted badges are completed by the COR on a Memorandum to the Operations and Security (S2) office, signed by the S2 shop, and provided to the Staff Duty desk for said individuals. Prior to receiving the non-escort/escorted badge, individuals will be vetted by the local Program Management Office (PMO). Vetting is done by completing the Fort Detrick Form 190-13, filled out by the COR with the receiving person’s information and signed by the S2 office. Once signed by the S2 office, the information is then passed to the Visitor Control Center (VCC) for background checks, which must be accomplished two weeks ahead of scheduled work. All persons entering the Forrest Glenn Annex shall have a background check conducted, whether local or through other official means. Visitors will be escorted at all times in WRAIR facilities (A.003).

1.7.4 Access and General Protection/Security Policy and Procedures/ Background Checks: The contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, Defense Health Headquarters (DHHQ), 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.003).

1.7.4.1 United States (U.S.) Citizen: The Requiring Activity Manager will determine the extent of background checks required. The contractor employee may begin performance of the contract after receiving a favorable local background check. The contractor agrees to replace the employee should results of the background check be unfavorable as determined by the Requiring Activity Manager. The contractor’s replacement of the employee with the unfavorable background check shall be within a timeframe provided by the Requiring Activity Manager. The contractor shall also replace employees whose background check, during their tenure of employment, renders them with an unfavorable local or stateside background check, as determined by the Requiring Activity Manager. The contractor shall forward a copy to the KO via the COR and the Requiring Activity Manager of each favorable background check within 10 days of receipt by the contractor, identifying such with the appropriate contract number. The contractor shall forward a copy to the KO via the COR and the Requiring Activity Manager of each unfavorable background check within five days of receipt by the contractor, identifying such with the appropriate contract number. When the Government awards a non-personal services contract directly to an individual, the failure of the individual to provide a favorable background check would be grounds for termination (A.003).

1.7.4.2 Local Nationals and Third Country Nationals: RESERVED.

1.7.5 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 in accordance with the Army Physical Security Program, Army Regulation (AR) 190-13.

1.7.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions in accordance with AR 530-1. 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.

1.7.6.1 Operations Security (OPSEC) Program: RESERVED.

1.7.7 Key Control: RESERVED.

1.8 Post Award Conference/Periodic Progress Meetings: The contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The KO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the KO 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 meetings shall be at no additional cost to the Government.

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.

1.9 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the KO, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the contractor by the KO. 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, and specifications; monitor contractor's performance and notify both the KO and contractor of any deficiencies; coordinate availability of Government property; and coordinate site entry of contractor personnel.

1.10 Contractor Personnel: All contractor service technicians performing work shall be trained in Good Manufacturing Practice (GMP)/Food and Drug Administration (FDA) requirements, with a licensed electrician and plumber on staff. Technicians shall receive factory training by equipment manufacturers. Training records must be stored and maintained by the contractor and provided to the PBF upon request. The contractor shall fill vacant positions within 30 days. If contractor positions are vacant for more than 30 days, the COR will provide a Contract Deficiency Report (CDR) to the KO (PRS #1).

1.10.1 Key Personnel: RESERVED.

1.10.2 Essential Personnel: Non-mission essential contract personnel shall not report to work on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation, or by direction of the Installation Commander for any other reason. During these periods of closure, contractor employees that are not designated as essential in accordance with this contract shall not report for work nor will they be compensated for those days. Contractor personnel/tasks considered essential include emergency services (e.g., if water for injection/pure steam distribution systems incur a failure mode) (see PWS paragraph 5.3.1).

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 must 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.

1.11.1 Contractor Communication: Contractor employees shall identify themselves by name and company affiliation when answering the telephone, presenting briefings, and conducting or attending meetings and seminars. All contractor correspondence (e.g., written, facsimile, and email display) shall include their company name.

1.11.2 Contractor Identification: Contractor personnel shall be easily identifiable through the display of badges and/or company uniform. The contractor (to include subcontractors) shall provide each of their employees an easily readable identification badge and/or company uniform.

1.12 Contractor Travel: All work performed under this PWS will occur on-site at 501 Robert Grant Avenue, Silver Spring, MD 20910, Building 501 where the water for injection/pure steam distribution systems are installed. Any travel required to meet PWS requirements (e.g., emergency service) shall be at the contractor’s expense.

1.13 Other Direct Costs (ODCs): Due to the unpredictable nature of emergency service(s), emergency maintenance shall be invoiced as ODCs under a cost type Contract Line Item Number (CLIN) to include all labor, materials, and supplies required to complete the necessary repairs. The contractor shall manage and account for all costs associated with requirements labeled as ODCs, not to exceed the price ceiling listed in this contract. All ODCs exceeding $3,000.00 require appropriate competition and approval from the KO prior to purchase.

Equipment purchases are not authorized under this contract.

1.13.1 Invoices: The contractor shall submit invoices monthly to the Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice. The contractor is responsible for properly preparing and forwarding the invoice and receiving report for payment to the appropriate Government official. The WAWF – Receipt and Acceptance application is the required method of submission (A.004).

1.13.2 Backup: The contractor shall attach backup information to receiving reports for ODCs. Backup information for ODCs shall list all elements of costs (A.004).

1.14 Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, 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 materials may not be used or sold by the contractor without written permission from the KO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.15 Non-Disclosure Requirements: RESERVED.

1.15.1 Non-Disclosure Statements: RESERVED.

1.16 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense Imagery Management Operations Center (DIMOC) and contained at 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.

1.17 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work under this contract may receive, have access to, 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 KO 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 KO to avoid or mitigate any such OCI. The contractor’s OCI mitigation plan will be determined to be acceptable solely at the discretion of the KO. In the event the KO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the KO 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 (A.005).

1.18 Phase In /Phase Out Period: RESERVED.

1.19 Safety: The following provides information pertaining to safety and accident prevention:

1.19.1 The contractor shall 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 their position and report any infractions of safety procedures to the COR immediately. The contractor shall comply with Occupational Safety and Health Administration (OSHA) standard number 1904.32 and maintain an OSHA 300A log for all reportables (greater than first aid, lost time, lost days, and transfer). The contractor shall provide a quarterly report of all mishaps, regardless of class or reportability. In addition, the contractor shall deliver the annual OSHA 300A report by 1 February of each year. The contractor shall ensure compliance with occupational health physicals or vaccinations in support of the PWS (A.006).

1.19.2 Safety Laws and Regulations: The contractor shall comply with FAR 52.236- 13, Accident Prevention (November 1991), the references contained therein (e.g., U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)).

http://www.dimoc.mil/resources/limitations/

The requirements under FAR 52.236-13 and specifically of the EM 385-1-1 include, but are not limited to the following:

a. Before initiation of work at the job site, an Accident Prevention Plan, written by the contractor for the specific work and hazards of the contract and implementing in detail the pertinent requirements of EM 385-1-1, will be reviewed for acceptance by designated Government personnel. Specific requirements for development of the Accident Prevention Plan are found in 01.A and Appendix A of EM 385-1-1. EM 385-1-1 is available online at www.usace.army.mil (A.007).

b. Before beginning each activity involving a type of work presenting hazards not experienced in previous project operations or where a new work crew or subcontractor is to perform work, an Activity Hazard Analysis (AHA) shall be prepared by the contractor performing the work activity (see paragraph 01.a.09 of EM 385-1-1) (A.008).

c. The contractor shall require subcontractors to submit their plan of operations showing methods they propose to use in accomplishing major phases of work.

d. The contractor shall discuss the plans in conferences convened by the KO prior to starting work on each major phase of operation. Plans shall include all pertinent information such as layout of haul roads, access roads, storage areas, electrical distribution lines, methods of providing minimum exposure to overhead loads, and methods of access to work areas. The plan for accomplishing the initial work phase shall be submitted within 15 days after contract award. Plans for subsequent major phases of work shall be submitted no later than 15 days prior to initiation of work on each major phase (A.009).

e. In all areas where construction, demolition, alteration, building, or similar related activities take place, the contractor shall have the following minimum personal protective clothing and equipment requirements in place for any person working on or visiting the site: short sleeve shirt, long trousers, steel-toed safety boots, and hard hat.

1.19.2.1 In addition to other requirements for accident prevention specified in this contract, the contractor shall comply with all Federal and State requirements governing safety and health protection on construction sites and other applicable occupational safety codes.

The contractor shall indicate its plan for compliance considering conditions of the work described by the design, technical proposal, operational activities of the Government or others in the area of the work, identification of the coordinator, and implementation of all other accident prevention provisions of this contract (A.010).

1.19.2.2 The contractor shall complete and provide all required safety notifications and provide documented proof to the KO via the COR within five days of such notifications being made (A.011).

1.20 Environmental Compliance: The following provides information on environmental compliance.

1.20.1 Environmental Compliance Plan and Program: The contractor shall abide by all state, federal, and local regulations regarding the safe disposal of any chemicals or other hazardous materials used or generated during the performance of this PWS.

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

Training courses are available on Joint Knowledge Online (JKO) (https://jkodirect.jten.mil) or instructions for completion will be provided by the COR. Most trainings are approximately one to two hours in duration and will be required prior to commencing work under the contract, with refresher training required annually. Example courses include, but are not limited to, the following:

JKO Course Number Course Name JS-US007 Level I Antiterrorism Training JS-US009 Joint Staff Operations Security Training

DOD-US1364 Series DoD Cyber Awareness Challenge DHA-US001 HIPAA and Privacy Act Training

DHA-US1338 Controlled Unclassified Information (Initial) DHA-US1339 Controlled Unclassified Information (Refresher) DHA-US1369 OSD Records and Information Management DHA-US438 DoD Annual Security Awareness Training

(A.012).

1.21.1 Anti-Terrorism (AT) Level I Training: All contractor employees, including subcontractor employees, requiring access to Government 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, and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR (or to the KO if a COR is not assigned) within five calendar days after completion of training by all employees and subcontractor personnel. The Army’s AT program is part of a broader national program of combating terrorism that is governed by AR 525-13, Antiterrorism Force Protection: Security of Personnel, Information, and Critical Resources (A.012).

1.21.1.1 Anti-Terrorism (AT) Awareness Training for Contractor Personnel Traveling Overseas: RESERVED.

1.21.2 Operations Security (OPSEC) Training: RESERVED.

1.21.3 iWATCH/Suspicious Activity Reporting Training: The contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training 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 five calendar days of new employees commencing performance, with the results reported to the COR no later than 30 calendar days after contract award (A.012).

1.21.4 Information Assurance (IA) Training

1.21.4.1 Cyber Awareness (Information Assurance (IA)/Information Technology (IT) Training: RESERVED.

1.21.4.2 Cyber (Information Assurance (IA)/Information Technology (IT) Certification:

RESERVED.

1.21.4.3 Service Training Certification Tracking System (STCTS) Registration for Contractor Employees Who Require Access to Government Information Systems:

RESERVED.

1.21.5 Personally Identifiable Information (PII): Contractor employees, including subcontractors, performing services under this contract with access to PII and Government information shall complete “Identifying and Safeguarding PII” within 30 calendar days of employment. Contractor personnel shall complete refresher training every 12 months from initial completion. The contractor shall provide the COR a copy of the training certificates for its employees no later than five days after completion (A.012).

1.21.6 Threat Awareness Reporting Program (TARP): Per Defense Health Agency- Administrative Instruction (DHA-AI) 097, Insider Threat Program, contractor employees with security clearances must receive annual Insider Threat Awareness training within 30 days of initial employment, and refresher training annually either through instructor-led or computer-based (A.012).

1.21.7 Compliance Training: The contractor shall abide by CGMP and Good Documentation Practices (GDP) and may be required to complete PBF specific training on internal Standard Operating Procedures (SOPs) (PRS #2 and PRS #3).

1.22 Authorization to Perform Services in Foreign Countries: RESERVED.

1.23 Notice to Proceed: The notice to proceed will be provided as indicated below.

☐ The effective date of contract will constitute the date of notice to proceed.

☐ A notice to proceed letter will be issued.

☐ The date of the letter transmitting the contract will constitute the date of the notice to proceed.

1.24 Electromagnetic Compatibility Directive: RESERVED.

1.25 Government Property and Services: Refer to Part 3 of this PWS for Government property applicable to this contract.

1.26 Conventional Forces Europe (CFE) Treaty Verification Inspection: RESERVED.

1.27 Contract Management:

1.27.1 Government Management: The COR for this contract will be appointed by the KO. The COR will serve as the primary Point of Contact (POC) for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

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

1.27.1.2 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.

1.27.2 Contractor Management: The contractor shall designate a single program manager to be the contractor’s authorized POC with the COR. The program manager 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 relating to the contract, or proposed changes or modifications to the contract.

1.27.3 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.

1.27.4 Subcontract Management: The contractor may add subcontractors to their team after notification and written approval from the KO. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract. Privy of contract is with the contractor and the subcontractor. The contractor is responsible for managing task distribution to ensure there are no OCI considerations and is accountable for subcontractor performance on this contract.

PART 2

DEFINITIONS AND 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 (KO) – 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 Defense Federal Acquisition Regulation Supplement (DFARS) 202.101, means an individual designated and authorized in writing by the KO 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, must be certified in accordance with this instruction. For example, local terminology can be COR, KO’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, AR 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 KO 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 (CAP) - means property acquired, fabricated, or otherwise provided by the contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a business day (i.e., Monday through Friday).

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

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

Government Furnished Property (GFP) – As reflected in FAR 52.245-1, GFP “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the contractor for performance of a contract. GFP includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. GFP also includes CAP if the CAP 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 GFP and CAP. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

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

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.

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 QC 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 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 (QC) – means all necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

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

Work Day - 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.

AHA Activity Hazard Analysis AQL Acceptable Quality Level AR Army Regulation AT Anti-Terrorism CAC Common Access Card CAP Contractor Acquired Property CDR Contract Deficiency Report CEC Center for Enabling Capabilities CFE Conventional Forces Europe CGMP Current Good Manufacturing Practice CLIN Contract Line Item Number COR Contracting Officer’s Representative DFARS Defense Federal Acquisition Regulation Supplement DHA-AI Defense Health Agency-Administrative Instruction DHHQ Defense Health Headquarters DIMOC Defense Imagery Management Operations Center DoD Department of Defense DoDI Department of Defense Instruction EST Eastern Standard Time FAR Federal Acquisition Regulation FDA Food and Drug Administration FPCON Force Protection Condition FTE Full Time Equivalent FY Fiscal Year GDP Good Documentation Practices GFP Government Furnished Property GMP Good Manufacturing Practice IA Information Assurance IAC Installation Access Control ISO International Organization for Standardization IT Information Technology JKO Joint Knowledge Online KO Contracting Officer MD/MS Medical Devices/Medical Device Systems NCIC-III National Crime Information Center Interstate Identification Index OCI Organizational Conflict of Interest ODC Other Direct Cost OEM Original Equipment Manufacturer OPSEC Operations Security OSHA Occupational Safety and Health Administration PBF Pilot Bioproduction Facility PBSC Performance-Based Service Contracting PII Personally Identifiable Information PLC Programmable Logic Controller PMO Program Management Office POC Point of Contact

PoP Period of Performance PRS Performance Requirements Summary PWS Performance Work Statement QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan SAM System for Award Management SCR Service Contract Report SN Serial Number SOP Standard Operating Procedure STCTS Service Training Certification Tracking System TARP Threat Awareness Reporting Program TMDE Test, Measurement, and Diagnostic Equipment TOC Total Organic Carbon TSDB Terrorist Screening Database U.S. United States USP United States Pharmacopeia VCC Visitor Control Center WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research

PART 3

GOVERNMENT PROPERTY AND SERVICES

3. Government Property and Services:

3.1 Services: RESERVED.

3.2 Facilities: The Government will provide the contractor with access to facilities at 503 Robert Grant Avenue, Silver Spring, MD 20910, Building 501 where the water for injection/pure steam distribution systems are installed. The Government will arrange for the contractor to have access to all necessary military installations and facilities necessary to complete all aspects of the tasks on an as-needed basis.

3.3 Utilities: All utilities in Government facilities will be available for the contractor’s use in performance of tasks outlined in this PWS. The contractor shall instruct employees in utilities conservation practices to preclude the waste of utilities, which include turning off water faucets, valves, and light switches after using the required amount to accomplish tasks requiring the use of such utilities.

3.4 Equipment: The Government will provide access to the installed water for injection/pure steam distribution systems (MECO SNs 9805 and 9806) upon which maintenance services are to be performed.

3.5 Special Tooling and Test Equipment: RESERVED.

3.6 Materials: The Government will provide any applicable protocols, SOPs, local instructions, and policies.

3.7 Training: The Government will provide instructions for accessing the required training identified in PWS paragraph 1.21.

3.8 Common Access Cards (CACs): RESERVED.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services:

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

4.2 Security Clearance: The contractor does not require facility or personnel security clearance; however, contractors may require a Public Trust determination.

4.3 Materials: The contractor shall provide all rigging, materials, supplies, and like-for-like piece/parts required to complete maintenance and repairs for the continued operation of water for injection/pure steam distribution systems.

4.4 Equipment: The contractor shall provide all necessary equipment, to include rigging, to perform the work described in this PWS.

4.5 Background Checks: The contractor shall provide background checks as determined by the Government (see PWS paragraph 1.7.4) (A.003).

PART 5

SPECIFIC TASKS

5.1 General Requirements: The contractor shall perform preventative maintenance (quarterly, semiannual, and annual), calibration, five-year overhaul, and emergency service, including all materials and supplies required to complete maintenance and repairs, for the continued operation of water for injection/pure steam generation and distribution systems (manufacturer: MECO) installed and used within the WRAIR, PBF to supply process water to autoclaves, fermenters, various other equipment, and manual use points as well as pure steam for sterilization in support of CGMP (PRS #3). The contractor shall keep the water injection system, pure steam generation system, and all corresponding distribution systems in complete working order at all times.

5.1.1 Procedural Requirements: All contractor technicians shall sign in and out of the PBF visitor logbook and conform to lockout/tagout safety procedures common within industry for water, high temperature, weight bearing, and electrical systems. Contractors shall be required to conform to PBF cleanroom gowning requirements, as needed, during any activity.

5.1.2 Documentation Requirements: 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 standard industry practices (e.g., FDA GMP GDP), 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 (PRS #2 and PRS #3).

5.1.3 On-Site Repair Requirements:

a. The contractor shall respond within 24 hours (seven days a week) (PRS #4).

b. The Government and the contractor will exchange hazard communication information before the commencement of any repair.

c. When required, the contractor will comply with the OSHA lockout/tagout standards while performing maintenance on Medical Devices/Medical Device Systems (MD/MDS).

d. The contractor shall communicate to the COR any major deficiencies or issues encountered during a service visit prior to leaving the facility (PRS #5).

e. Upon completion of services by the contractor, a service report shall be provided to the COR.