B08-PWS Final.pdf

PERFORMANCE WORK STATEMENT

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. CONTRACT MANAGEMENT

10. ATTACHMENTS

PWS

PERFORMANCE WORK STATEMENT (PWS)

Title: PBF Water for Injection/Pure Steam/Distribution Systems Preventive Maintenance and Service

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR)

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neuro-trauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The Pilot Bio-production Facility (PBF) conducts research, development, production, and testing of vaccines and other biological products. Production is performed following and products are tested in compliance with current Good Manufacturing Practices (cGMP). Production is pilot-scale: 500 – 20,000 doses per finished lot of product. Products are released for use in Phase I – II b clinical studies under Investigational New Drug applications (INDs). Vaccines being produced include, but are not limited to, those for prophylaxis against shigellosis, meningitis, malaria, and dengue fever. Conventional as well as recombinant and other genetically engineered vaccines are undergoing development and production at WRAIR. Other types of biological products (i.e. therapeutics) are capable of being produced as well under the right circumstances.

A multiple effect distillation unit has been installed that vaporizes Reverse Osmosis/Deionized CAP II water. WFI is condensed from the PS output of up to three multiple effect distillation columns, which is then sent to a WFI storage tank. The contents of the storage tank is then circulated by the WFI distribution pumping system. 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 WFI tank. A fraction of the PS 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.

3. SCOPE

The contractor will perform Quarterly, Bi Annual, Annual Maintenance, Five Year Overhaul, Preventive Maintenance, Emergency Maintenance, and Periodic/Volumetric Maintenance for the WFI/PS Systems.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 15 April 2020 –14 April2021 Option period 1 15 April 2021 –14 April 2022

Option period 2 15 April 2022 – 14 April 2023 Option Period 3 15 April 2023 – 14 April 2024 Option Period 4 15 April2024 – 14 April 2025

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is 503 Robert Grant Avenue, Silver Spring, MD 20910, Building 501.

5.1.1. Telecommuting

Telecommuting is not feasible for the services provided under this contract. Medical equipment maintenance, administrative, and professional support services must be performed on site

5.1.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Managers to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, including base closures, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

Contractor 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, the contractor employees that are not designated as essential IAW this contract shall not report for work nor will they be compensated for those days. Essential personnel tasks include the following: Emergency Maintenance Work

5.2. Federal Holidays

5.2.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

5.2.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed

The following are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

5.3. Post Closure

All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the mission essential contractor personnel shall report for work.

If the WFI/Purse Steam system incurs a failure mode, mission essential contract employees shall still complete work unless downtime is approved by the Army command.

5.4. Work Schedule

The contractor shall provide non-emergency support from 0600 to 1800 Eastern Time.

6. PERFORMANCE REQUIREMENTS

6.1. Specific Tasks / Requirements

6.1.1. Quarterly: Review of Unit Operation (Includes Daily/Monthly checks) (Deliverable 2)

• Perform Operational Safety checklist.

• Check that the calibration status of all instruments are within the expected range of operation.

Recalibrate instruments as necessary.

• Check the distillate NORMAL / DUMP switch for operation. Observe the valves changing position.

• Check the entire unit for leaks.

• Blow down steam and condensate strainers.

• Check and adjust blowdown flow.

• Calibrate sanitary pump effluent discharge flow.

6.1.2. Biannual (every six months) (Deliverable 3):

• Perform TOC/conductivity analyzer calibration.

• Replace sanitary pump seals, as needed.

6.1.3. Annual: Replacement of Product Contact Elastomers (Includes Quarterly and Biannual Items) During

Maintenance Shutdown (Deliverable 4)

• Perform all routine quarterly PM items listed above (section 6.1.1).

• Perform loop calibration of all sensors (TOC, conductivity, pressure, flow) and variable frequency drives.

• Perform calibration of all gauges.

• Replace filters, including 0.2 micron vent filters.

• Chemically clean the units, tank, and distribution piping.

• Replace feed water pump seals, if required.

• Check steam traps and strainers, rebuild if required.

• Check all electrical connections on the skids.

• Check and descale cooling water side of condenser as required. Rigging is required.

• Check and descale heat exchangers. Rigging is required.

• Replace gaskets on each effect evaporator, as needed.

• Replace condenser gaskets.

• Perform hydrostatic test of condenser and all effects, if required.

• Perform hydrostatic test of distribution loop heat exchangers.

• Change PLC batteries.

• Replace product contact piping gaskets, orifice gaskets, and valve diaphragms in the WFI/PS, Distribution System, and use points.

• Upon completion of the annual maintenance work perform de-rouging, passivation, cleaning, rinsing, and re-sanitization of the WFI/PS tank, distribution piping systems, heat exchangers and field use points, as needed, to return the system to USP Chapter <1231> generation specifications.

6.1.4. Five Year Overhaul: Replacement of all System Elastomers (Includes Annual Items) (Deliverable 5)

• Perform all annual PM items.

• Re-gasket the entire units (WFI/PS and Distribution Systems).

• Rebuild all diaphragm valves.

• Repack degasser, as necessary.

6.1.5. The vendor shall supply all rigging, materials, supplies, and like-for-like piece/parts for the WFI/PS, and Distribution systems. Calibration per ISO 17025 requirements of all components of the system that include but are not limited to TOC, conductivity, time, pressure, temperature, and flow with recorded as-found and as-left values. An overall safety assessment report is to be included during annual maintenance.

6.1.6. Emergency Services: The contractor shall provide up to two emergency service visits per contract year per system (WFI/PS/Distribution – 3 systems) with a response time not to exceed 24 hours including evaluation of failure mode, repair and/or replacement (or as soon as possible) for any piece or part of the WFI/PS systems.

6.1.7. Training: All technicians performing work must be trained service technicians with training records indicating training in Good Manufacturing Practice (GMP)/FDA requirements, with a licensed electrician and plumber on staff. Technicians shall receive factory training and certification by equipment manufacturers. Training records must be stored and maintained by the service vendor and provided to the PBF upon request (Deliverable 8).

6.1.8. Technicians: All technicians must sign in and out of the PBF daily in the visitor logbook. All technicians will conform to lock out-tag out safety procedures common within industry for water, high temperature, weight bearing, and electrical systems. Technicians will be required to conform to PBF cleanroom gowning requirements, as needed, during any activity.

6.1.9. Additional Services: The contractor shall provide additional emergency services as required with a response time not to exceed 24 hours.

6.1.10 Compliance: The contractor shall abide by current Good Manufacturing Practice (GMP) and Good Documentation Practices (GDP).

6.2. Management Reports and Plans

Maintenance Reports (Deliverable 1): A written report for each service performed to repair/calibrate/maintain the WFI/PS systems shall be delivered within 30 days of each activity. All reports must follow good documentation practices, be legible, and include the full name and signature of personnel performing any work.

Calibration, safety, or piece/part failure must be documented.

Quality Control Plan (Deliverable 7). The contractor shall provide a draft Quality Control Plan (QCP) no later than 15 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.

Contract Manpower Reporting Application (CMRA) (Deliverable 6). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at: http://www.ecmra.mil/.

The contractor shall register under the "All Other Defense Components" module. The WRAIR Unit Identification Code (UIC) is W03KAA. The Federal Supply Code (FSC) is J046.

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.

http://www.ecmra.mil/ http://www.ecmra.mil/

7.1 DELIVERABLES TABLE

PWS

Ref. Number Title/Description Due

6.2 Deliverable 1 Maintenance Reports Reports shall be due no later than 15 days after maintenance has been performed.

6.1.1 Deliverable 2 Quarterly Maintenance

The contractor shall perform all items required for the quarterly maintenance review.

The first quarterly maintenance shall be scheduled and completed no later than 30 days after contract award and then quarterly thereafter.

6.1.2 Deliverable 3 Biannual Maintenance

The contractor shall perform all items required for the biannual maintenance review.

The first biannual maintenance review shall occur six months after contract award and then biannually thereafter.

6.1.3 Deliverable 4 Annual Maintenance

The contractor shall perform all items required for the annual maintenance review.

To be performed during maintenance shutdowns.

6.1.4 Deliverable 5 Five Year Maintenance Overhaul Completed no later than 30 days before contract termination.

6.2 Deliverable 6 Contract Manpower Reporting Application

The contractor shall complete and deliver the

CMRA.

By October 31 or on the last day of contract performance – whichever comes first

6.2 Deliverable 7 Quality Control Plan No later than 15 days

after contract award.

6.1.7 Deliverable 8 Training Documentation Upon Request

11.0 Deliverable 9 AT/OPSEC Requirements under Section 10. No later than 30 days after award

8.0 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 DFAR clause 252.227-7013, Rights in Technical Data- Noncommercial Items. 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 (FDA GMP Good Documentation Practice), 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.

8.1 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 Performance Work Statement and all terms and conditions of this order, including all modifications.

8.2 COR Information

To be determined after award.

9.0 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. 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).

9.1 Performance Requirements Summary Matrix

# PWS

Ref.

Performance Objective

Acceptable Quality Level

Performance Measurement

Method of Surveillance Incentive

1 6 The contractor shall complete maintenance in a timely manner.

Meets >95% of the time.

Number of times the contractor completes the objective.

COR surveillance Past performance.

2 6.2 The contractor shall submit maintenance reports in a timely manner.

Meets >99% of the time.

Number of times the contractor completes the objective.

COR surveillance Past performance.

3 6.1.6 The contactor shall perform emergency service work in a timely fashion.

Meets >99% of the time.

Number of times the contractor completes the objective.

COR surveillance Past performance.

4 5.1.2 The contractor shall provide emergency service work when necessary.

Meets >99% of the time

Number of times the contractor completes the objective.

COR surveillance Past performance.

5 6.1.9 The contractor shall provide documentation of Good Documentation Practice.

Meets >99% of the time.

Number of times the contractor complies when requested by the COR.

COR surveillance Past performance.

6 6.1.9 The contractor shall provide work in accordance to cGMP standards.

Meets >99% of the time.

Number of times the contractor shows compliance when requested by the COR.

COR surveillance Past performance.

10. CONTRACT MANAGEMENT

10.1 Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). 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.

10.2 Contractor Management

The contractor shall designate a single 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 relating to the contract, or proposed changes or modifications to the contract.

10.3 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.

10.4 Contractor Vacant Positions

The contractor shall fill vacant positions within thirty (30) business days. If contractor positions are vacant for more than thirty (30) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

10.5 Subcontract management

10.5.1 The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

10.5.2 The contractor is responsible and accountable for subcontractor performance on this contract

10.5.3 The contractor is responsible to manage task distribution to ensure there are no

OCI considerations

10.5.4 Contractor my add subcontractors to their team after notification and written approval from the KO.

10.5.5 Privy of contract is with the contractor and the subcontractor…..

10.6 Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) 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. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. 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.

11.0 SECURITY REQUIREMENTS:

11.1 AT Level I training.

All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 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

11.2 Access and general protection/security policy and procedures.

Contractor and all associated sub-contractors 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, 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.

11.2.1For contractors that do not require CAC, but require access to a DoD facility or installation.

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

12.0 ATTACHMENTS

Attachment 1 – Acronyms List Attachment 2 – WRAIR Organization Chart

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition AFARS Army Federal Acquisition Regulation Supplement

AFRIMS Armed Forces Research Institute of Medical Sciences 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 Than 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 USAMRD-G United States Medical Research Directorate – Georgia USAMRD-A United States Medical Research Directorate – Africa

WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research

ATTACHMENT 2 – WRAIR ORGANIZATION CHART