B01 Request for Information_DRAFT PWS ClonePix2 Preventative Mainteance (20 Sept 2023).pdf

Request for Information (RFI)

Requiring Activity Name: For the, Pilot Bioproduction Facility (PBF), Walter Reed Army Institute of Research (WRAIR)

Subject: Service Preventative Maintenance for the ClonePix2 with monoclonality assurance instrument owned by the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF).

This is a Request for Information (RFI)/Sources Sought (SS) as defined in FAR 15.201(e) to ascertain whether a commercial service exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

This Market research is seeking capable sources that have knowledge and abilities to provide Service Preventative Maintenance for the ClonePix2 with monoclonality assurance instrument currently owned by the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF). The NAICS code for this requirement is 811310 – Commercial and industrial Machinery and Equipment (Except Automotive and Electronic) Repair and Maintenance.

DISCLAIMER: This RFI is NOT a Request for Proposals (RFP) or a Request for Quotations (RFQ); This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Responses to the RFI will not be returned. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

No Contract will be awarded from this announcement. No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Responders are solely responsible for all expense associated with responding to this RFI. Availability of any formal solicitation will be announced under a separate announcement.

All information received in response to this RFI will be treated as business confidential information. Submitters should properly mark their responses if the information is confidential. All information received in response to this RFI that is marked Proprietary will be handled accordingly.

At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

RFI Response and due date: 2 October 2023

Background: The purpose of this requirement as detailed in the DRAFT Performance Work Statement (PWS) below for the provision of Service Preventative Maintenance to the ClonePix2 with monoclonality assurance instrument owned by the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF).

Instructions to Responders:

Responses from all capable and qualified sources are encouraged to respond to this request.

Review the attached DRAFT PWS. Respondents should address how they best can fulfil the requirements set forth in section 5 of the DRAFT PWS in their capabilities statement. Capability Statements or any other proprietary information relative to this RFI should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats:

Microsoft Word or Adobe PDF and shall not exceed 3 pages (Cover page excluded from page count).

2. Cover Page

• Title

• Organization

• CAGE Code and Unique Entity Id (UEI)

• Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

• Topic area(s) addressed

• Respondents shall be able to perform under the NAICS code 811310 – Commercial and industrial Machinery and Equipment (Except Automotive and Electronic) Repair and Maintenance.

3. Please note that the response provided shall provide sufficient technical data to determine how you will fully meet the requirements as specified in the DRAFT Performance Work Statement.

Please note that responses are due no later than 2 October 2:00PM EST. The preferred method of submission is via email. The point of contact for this action is Jaclyn Svincek, Contract Specialist Jaclyn.p.svincek.civ@health.mil. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE

CALLS PLEASE.

DRAFT

PERFORMANCE WORK STATEMENT

FEB 23

PERFORMANCE WORK STATEMENT (PWS)

ClonePix2 Service and Maintenance

Part 1

General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) 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 service(s) contract to provide repair services and preventive maintenance of the ClonePix2 with monoclonality assurance instrument owned by the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF).

1.2 Background: Since 1893, 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 at its Washington, D.C., area, and expeditionary laboratories function in concert to 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.

The PBF conducts research, development, production, and testing of vaccines and other biological products. Production is performed and products are tested in compliance with current Good Manufacturing Practices (GMP). Production is pilot-scale: 500 – 2,000 doses per finished lot of products. Products are released for use in Phase I - IIb 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.

The WRAIR PBF offers manufacturing process development scope in order to facilitate the tech transfer of research and development products into GMP manufacturing for clinical trial use. As a part of this scope, the PBF provides stable cell line development and clonal selection utilizing the ClonePix2 instrument with monoclonality assurance. In order to support regulatory IND applications with the Food and Drug Administration (FDA) for Phase 1 clinical trials, proper documentation must be provided that demonstrates that the starting cell bank was propagated from a single cell clone. The ClonePix2 was purchased with monoclonality assurance to support these documentation requirements.

As a GMP compliant facility, the PBF has standard operating procedures which define the service and maintenance requirements of all equipment that will be used to produce GMP material or support regulatory filings to the FDA. As equipment used to support the lineage history of cell banks the ClonePix2 falls under this requirement and must be maintained at least annually. Additionally, the PBF requires on-site response times for repair service calls within 72 hours of notification to minimize downtime and impacts to ongoing projects.

1.3 Scope: The Contractor shall provide non-personal services. This shall include providing maintenance, instrument services, repair, parts, labor, and travel as described in the 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 identified in this PWS and associated contract documents.

1.3.1 Period of Performance: The period of performance shall be as follows:

Base Period 01 January 2024 – 31 December 2024 Option Period 1 01 January 2025 – 31 December 2025 Option Period 2 01 January 2026 – 31 December 2026 Option Period 3 01 January 2027 – 31 December 2027 Option Period 4 01 January 2028 – 31 December 2028

1.4 Objective: The objective of this contract is to provide service and maintenance for the WRAIR, PBF ClonePix2 instrument with monoclonality assurance to maintain proper working order to meet GMP guidelines.

1.5 General Information:

Contracting Officer Representative (COR):

Dr. Stasya Zarling Phone: (301) 319-7143 Email: stasya.n.zarlingbejma.civ@health.mil

1.5.1 Quality Control Plan (QCP): The Contractor’s existing quality assurance system shall be utilized In Accordance With (IAW) Federal Acquisition Regulation (FAR) 12.208.

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

1.5.3.1 U.S. Holidays: Work shall be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the 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.

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

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

Please refer to the following.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are 0800 to 1700, 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 to 1800, Monday through Saturday. The Government facility is open for operations during the recognized U.S. Holidays identified in paragraph 1.5.3.1 above. The facility may close due to local or national emergencies, administrative closings, or host nation national holidays.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support during same hours as the supported Government organization.

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 COR for review within ten days after date of contract award. The Government will review and either accept or return their comments to the Contractor within ten 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 a minimum 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 (for example, 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 after the training holiday.

1.5.6 Place of Performance: The work to be performed under this contract will be performed at Walter Reed Army Institute of Research (WRAIR) Fort Detrick, Maryland.

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

1.6.1 Security Program: Reserved.

1.6.2 Personnel Security Clearance Requirements: Reserved.

1.6.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings, and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

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

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

1.6.3.1 Installation Pass Log: Reserved.

1.6.3.2 Individual Termination or Expiration of Employment: Reserved

1.6.3.3 Contract Termination or Cancellation: Reserved

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

1.6.4 Background Checks: Reserved.

1.6.4.1 U.S. Citizen: Reserved.

1.6.4.2 Local Nationals and Third Country Nationals: Reserved.

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

1.6.6 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7 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.

1.8.1 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, specifications, monitor Contractor's performance and notifies both the KO and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10 Key Personnel: Reserved.

1.11 Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties 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 Workspace: Contractor workspace (staging site, on-site office, desk or work area, etc.) shall contain a sign signifying the space is occupied by Contractor employee(s) to ensure that Government employees and the public know that they are not Government employees. The proposed sign shall be submitted to the KO within ten days after contract award (A.002).

Workspace sign location shall be coordinated with the COR. Contractor employees shall identify themselves by name and company affiliation when answering the telephone, presenting briefings, conducting or attending meetings, and seminars. All Contractor correspondence (written, facsimile, and email display) shall include their company name.

Requirements for Contractor vehicles is addressed under Part 4 paragraph 4.4.

1.11.2 Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715).

The Contractor (to include subcontractors) shall provide each of their employees an easily readable identification badge. The badge must include the employee’s name, the contractor’s company name, the functional area of assignment, and a recent color photograph of the employee. Companies with U.S. Government contracts will require their employees to wear these badges visibly when performing work at Government workplaces unless this would be impractical because of mission or safety considerations.

The Contractor shall collect all identification (ID) badges upon completion of the contract or termination of employee. A listing of issued ID cards shall be furnished to the KO prior to the contract performance date and updated as needed to reflect Contractor personnel changes (A.002).

1.12 Contractor Travel: Reserved.

1.13 Other Direct Costs (ODCs): Reserved.

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

1.15.1 Non-Disclosure Statements: The Contractor shall provide signed non-disclosure agreements to the Government no later than 30 days prior to commencement of work under the contract. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this contract (A.003).

1.16 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center 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 or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications, or work statements, etc.) or perform evaluation services which may create a current or subsequent OCI as defined in FAR Subpart 9.5. The Contractor shall notify the 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.004).

1.18 Phase In /Phase Out Period: Reserved.

1.19 Safety: The following provides information pertaining to Safety and Accident Prevention:

1.19.1 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 on-site Government safety 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.005).

(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, activity hazard analysis (AHA) shall be prepared by the Contractor performing the work activity (See paragraph 01.a.09 of EM 385-1-1).

(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 calendar days after award of the contract. Plans for subsequent major phases of work shall be submitted no later than 15 calendar days prior to initiation of work on each major phase; and

(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.

1.19.1.1 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. For the compliance with host nation laws and regulations, the Contractor shall comply with the non-exclusive list of duties described in this paragraph.

http://www.usace.army.mil/

1.19.1.2 The Contractor shall complete and provide safety notifications required by host nation authorities and will provide documented proof to the KO via the COR, no later than 30 days that such notifications were made (A.005).

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

1.20.1 Environmental Compliance Plan and Program: Reserved.

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

1.21.1 Anti-Terrorism (AT) Level I Training: All Contractor employees, including subcontractor employees, who are employed under the contract, shall complete AT Level I Training within 15 days as required on the AT/OPSEC Cover Sheet after contract start date or effective date of incorporation of this requirement into the contract, whichever applies, or 15 days after employment of new personnel. Contractor personnel travelling overseas shall complete Area of Responsibility (AOR) specific AT awareness training for U.S. based Contractor employees and associated subcontractor employees. 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 30 days after completion of this training by all employees and subcontractor personnel.

AT Level I awareness training is available at https://jkodirect.jten.mil. Contractor personnel shall complete refresher training every 12 months except AOR specific AT Level I training which shall be completed as required by local AT policies (A.006).

If training cannot be conducted on the website, the Contractor shall coordinate with the COR who will contact the local AT Officer at their assigned location for classroom training.

Contractor personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the AT Officer. Verification of the training shall be provided to the COR within 15 days after completion of the training (A.006).

1.21.2 OPSEC Training: All Contractor employees, including subcontractors, shall complete Level I OPSEC training within 15 days of employment under this contract.

Verification of the training shall be provided to the COR within 15 days after completion of the training. OPSEC Level I training is available at http://www.cdse.edu/catalog/elearning/GS130.html. Contractor personnel must complete refresher training every 12 months. Verification of the training shall be provided to the COR within 15 days after completion of the training (A.007).

If training cannot be conducted on the website, the Contractor shall coordinate with the COR, who will contact the local OPSEC Officer at their assigned location for classroom training. Contractor personnel completing training in the classroom will receive a certificate or the training attendance roster signed by the OPSEC Officer. Verification of the training shall be provided to the COR within 15 days after completion of the training (A.010).

https://jkodirect.jten.mil/ http://www.cdse.edu/catalog/elearning/GS130.html

1.21.3 iWATCH Training: Reserved.

1.21.4 Information Assurance (IA) Training: Reserved.

1.21.5 Personally Identifiable Information (PII): Reserved.

1.22 Authorization to Perform Services in Kenya: Reserved.

1.23 Notice to Proceed: Reserved.

1.24 Electromagnetic Compatibility Directive: Reserved.

1.25 Government Property and Services: Reserved.

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

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

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

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

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the 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, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the 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 - 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 calendar day.

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

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

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

Government Property - means all property owned or leased by the Government.

Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

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.

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

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

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

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

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

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s).

Statements focus on “what” is to be accomplished; however, they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are like Level 3 in a Work Breakdown Structure.

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

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

Work Week - Monday through Friday, unless otherwise specified.

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

AHA Activity Hazard Analysis AOD Administrative Officer of the Day AOR Area of Responsibility AQL Acceptable Quality Levels AR Army Regulation AT Anti-terrorism ATCTS Army Training Certification Tracking System CAC Common Access Card CFE Conventional Forces Europe COR Contracting Officer’s Representative CV Curriculum Vitae DA Department of the Army DAIG Department of the Army Inspector General DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DOCPER Contractor Personnel Office DoD Department of Defense DoDD Department of Defense Directive FAR Federal Acquisition Regulation FDA Food Drug Administration FRG Federal Republic of Germany FSR Field Service Report FTE Full Time Equivalent GFP Government Furnished Property GMP Good Manufacturing Practices GP Government Property

HLO High Level Objective HIPAA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness IAC Installation Access Control IACO Installation Access Control Office IACS Installation Access Control System IAW In Accordance With ID Identification IGE Independent Government Estimate IND Investigational New Drug IT Information Technology JTR Joint Travel Regulation JPAS Joint Personnel Adjudication System KO Contracting Officer NISPOM National Industrial Security Program Operating Manual OCI Organizational Conflict of Interest ODC Other Direct Costs OEM Original Equipment Manufacturer OPSEC Operations Security OSHA Occupational Safety and Health Administration PBF Pilot Bioproduction Facility PII Personally Identifiable Information PM Preventative Maintenance PRS Performance Requirements Summary PWS Performance Work Statement QASP Quality Assurance Surveillance Plan QCP Quality Control Program RA Requiring Activity SAM System for Award Management SCR Service contract Report TASS Trusted Associate Sponsor System TMDE Test, Measurement, and Diagnostic Equipment US United States USC United States Code WRAIR Walter Reed Army Institute of Research

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: Reserved.

3.2 Facilities: Reserved.

3.3 Utilities: Reserved.

3.4 Equipment: Reserved.

3.5 Special Tooling and Test Equipment: Reserved.

3.6 Materials: Reserved.

3.7 Training: Reserved.

3.8 Common Access Cards (CAC): Reserved.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: Reserved.

4.2 Secret Facility Clearance: Reserved.

4.3 Materials: Reserved.

4.4 Vehicles and Equipment: Reserved.

4.5 Background Checks): Reserved.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide non-personal service(s) for the repair and preventive maintenance of the ClonePix2 instrument with monoclonality assurance.

The contractor shall provide all personnel, equipment, parts, labor, travel, and other items necessary to perform services as described in the PWS and associated contract documents. The contractor shall ensure that the instrumentation is maintained in compliance with the manufacturer’s established guidelines and performed by a qualified technicians certified by the manufacturer.

5.2 Tasks:

5.2.1 Preventive Maintenance (PM): The Contractor shall perform one scheduled Preventive Maintenance (PM) service visit each year to clean, lubricate, adjust, calibrate, upgrade software, perform remedial maintenance to replace worn or faulty parts, and install preventive maintenance kits as necessary to maintain the equipment within manufacturers operating specifications (PRS-1).

5.2.2 Field Service Reports (FSR): Accomplished tasks shall be documented in the form of written Field Service Reports (FSR) provided to the COR within 10 business days from time of work completion. FSRs shall be signed by either the equipment user or medical maintenance personnel. This shall include includes PM visits and emergency repair visits (A.008) (PRS-2).

5.2.3 Contractor Readiness: The Contractor shall provide all labor, material, supplies, tools, diagnostic software, and test equipment necessary to perform ClonePix2 with monoclonality assurance maintenance, repair, administrative, advisory, inventory, and training services for WRAIR (PRS-3).

5.2.4 Technician Experience: The contractor’s service representative shall be factory trained and desired to have two years of experience working on the contracted ClonePix2 equipment (PRS-4).

5.3 Maintenance Requirements:

5.3.1 For On-site Repairs:

5.3.1.1 Contracted services shall be performed within the period of performance defined by the contract. The contractor shall respond within four hours of any notifications pertaining to maintenance or repair of equipment. The contractor shall complete repair assessment within 72 hours of notification and complete the repair based upon part availability.

5.3.1.2 Prior to reporting to a service call, the contract’s services representation shall notify medical maintenance via email (usarmy.detrick.medcom-wrair.mbx.medical-mailto:usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil) maintenance@health.mil) and shall report in person or telephonically notify the maintenance manager, with building and room number, telephone number, prior to commencing services during normal duty operating hours (as defined in 1.5.4). During other than normal operating hours, the contractor's representative shall report to the Administrative Officer of the Day (AOD), building 503, Silver Spring, MD, Tel. (301) 319- 9000 and notify medical maintenance via email (A.009).

a) The government and the contractor's service representative shall exchange hazard communication information before the commencement of any repair.

b) When required, the contractor's service representative shall comply with the

Occupational Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance.

c) Upon completion of services by the contractor's service representative, a service report shall be provided to the COR or the AOD and submitted as an electronic copy of the service report to medical maintenance at usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil. The service report shall provide detailed information regarding the cause of the malfunction and corrective action taken. It shall include, at a minimum, the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with part numbers and prices for each part prior to leaving the facility (A.008).

d) In the event all information is not available to the contractor's service representative when services are performed, the initial service report/invoice shall include all available information to close work order within five days.

The contractor shall provide the balance of the required information to the clinical engineering manager no later than 10 days after services are completed (A.008).

e) Contractor shall use only Original Equipment Manufacturer (OEM) new or

OEM refurbished repair parts.

f) For all contracts that require calibration of systems, the contractor shall complete DD Form 2163 or DD Form 2164 (Verification/Certification Worksheet) in accordance with the instructions provided in AR 40-61.

Additionally, continuation sheet shall be attached to the DD Form 2164 indicating the manufacturer, model, serial number, and date of calibration expiration of all items of Test, Measurement, and Diagnostic Equipment (TMDE) used to perform the calibration (A.010).

5.3.2 The Contractor shall provide call in support 24 hours a day, seven days a week.

5.3.3 The Contractor shall include unlimited on-site service calls and provide labor and factory-approved parts for covered equipment.

mailto:usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil) mailto:usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil

5.3.4 The Contractor shall include travel costs for service personnel.

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

6.1.1 Department of Defense Contract Security Classification Specification (DD Form 254)

6.1.2 Department of Defense Security Agreement (DD Form 441)

6.1.3 National Industrial Security Program Operating Manual (DoD 5220.22-M)

6.1.4 Installation Access Control (AE Reg 190-16)

6.1.5 The Army Physical Security Program (AR 190-13)

6.1.6 Contractor Identification (AE Reg 27-715)

6.1.7 U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385- 1-1)

6.1.8 Information Assurance Workforce Improvement Program (DoD 8570-M)

6.1.9 Information Assurance Training Certification and Workforce Management Directive (DoDD 8570.01)

6.1.10 Information Assurance (AR 25-2)

6.1.11 Electromagnetic Compatibility Directive (2004/108/EC)

6.1.12 Policies and Procedures for Property Accountability (AR 735-5)

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary

7.2 Technical Exhibit B – Deliverables Schedule

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PERFORMANCE

OBJECTIVE

STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

PRS-1 - PWS para (5.2.1) Preventive Maintenance

The Contractor shall perform 1 scheduled preventive maintenance service visit each year to clean, lubricate, adjust, calibrate, upgrade software, perform remedial maintenance to replace worn or faulty parts, and install preventive maintenance kits as necessary to maintain the equipment within manufacturers operating specifications.

99% Compliance;

no more than 1 discrepancy found per month

Client direct observation, reported to the

COR.

Frequency: As performed

PRS-2 - PWS para (5.2.2)

FSR

Accomplished tasks shall be documented in the form of written FSR provided to the COR within 10 business days from time of work completion. FSRs shall be signed by either the equipment user or medical maintenance personnel. Includes PM visits and emergency repair visits.

99% Compliance;

no more than 1 discrepancy found per month

Client direct observation, reported to the

COR.

Frequency: Within 10 business days of each work completion

PRS-3 - PWS para (5.2.3) Contractor Readiness

The Contractor shall provide all labor, material, supplies, tools, diagnostic software, and test equipment necessary to perform maintenance, repair, administrative, advisory, inventory and training services for WRAIR.

99% Compliance;

no more than 1 discrepancy found per month, etc.

reported to the

COR.

Frequency:

Throughout period of performance

PRS-4 - PWS para (5.2.4) Technician Experience

The contractor’s service representative shall be factory trained and desired to have 2 years of experience working on the contracted equipment.

99% Compliance;

no more than one 1 discrepancy found per month, etc.

reported to the

COR.

Frequency:

Throughout period of performance

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

Deliverable Frequency # Copies Medium/Forma t Submit To A.001

Contractor Work Plan

(Para 1.5.4.3.1)

Draft due within 10 days after contract award; final work plan due within 3 days of receipt of Government comments on draft

Proposed changes thereafter due 30 days prior to implementation of proposed changes

1 Electronic document (MS Word, Excel, or

PDF)

COR

A.002

Contractor Identification Badge List and Workplace Signs

(Para 1.11.1, 1.11.2)

List of all issued ID cards due prior to contract performance

Proposed contractor sign due to COR for review and approval with 10 days of contract award.

1 Electronic document (MS Word, Excel, or

PDF)

COR

A.003

Non-Disclosure Agreements

(Para 1.15.1)

30 days before commencement of work under the contract

1 Electronic document (MS Word, MS Excel, or PDF)

COR

A.004

OCI Mitigation Plan

(Para 1.17)

Due immediately when Contractor becomes aware that such access or participation may result in an actual or potential OCI

1 Electronic document (MS Word, Excel, or

PDF)

COR

A.005

Accident Prevention Plan and AHA

(Para 1.19.1, 1.19.1.2)

Initial plan due within 15 days of contract award; plans for subsequent major phases due within 15 days prior to initiating work.

1 Electronic document (MS Word, Excel, or

PDF)

COR

t Submit To A.006

AT Certifications

(Para 1.21.1)

AT Level 1 training completed within 15 days of contract start or within 15 days of employment of new personnel, with certificates due within 30 days of online training completion or 15 days of classroom training completion

Refresher training completed annually

1 Electronic document (MS Word, MS Excel, or PDF)

COR

A.007

OPSEC Training Certificates

(Para 1.21.2)

Level 1 OPSEC training completed within 15 days of employment under the contract, verification due within 15 days of completion of training.

Refresher training due annually with verification due within 15 days of training completion

1 Electronic document (MS Word, MS Excel, or PDF)

COR

A.008

FSR

(Para 5.2.2, 5.3.1.2 (c), 5.3.1.2 (d))

Upon completion of services; in the event not all information is available when services are performed, initial service report due within 5 days, completed report within 10 days

1 Electronic document (MS Word, MS Excel, or PDF)

COR,

AOD, and medical maintenan ce (usarmy.de trick.medc om-wrair.mbx.

medical-maintenan ce@health mil) mailto:usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil mailto:usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil mailto:usarmy.detrick.medcom-wrair.mbx.