Attachment 1 - DRAFT PWS.docx

Performance Work Statement (PWS)

M&R Contract for 11 PCR instruments at BioTesting Division

ThermoFisher Scientific offers three levels of PCR thermal cycler maintenance plan, see: https://www.thermofisher.com/us/en/home/products-and-services/services/services-support-life-sciences-instruments/instrument-service-plans.html

98% uptime guarantee

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This PWS will closely mirror the AB Assurance plan.

Performance Work Statement (PWS)

1 Vision Procurement of a Maintenance and Repair (M&R) contract that assures consistent and calibrated operation of BioTest Division (BTD) Polymerase Chain Amplification (PCR) thermal cycler machines.

2 Mission To maintain operation of PCR thermal cyclers commensurate with ISO 17025 standards.

3 Purpose The PWS gives the contractor maximum flexibility to devise the best method to accomplish the required result. The PWS must also be descriptive and specific enough to protect the interests of the Government. For this contract, the manufacturer, Thermo Fisher/Life Technologies Corp., is the only authorized performer of this service.

4 Background BTD utilizes real-time, quantitative PCR (RT-qPCR) for quality assurance and quality control (QA/QC) of materials used to test biological defense systems.

5 Scope This M&R contract will cover three (3) ViiA7 thermal cyclers, six (6) QuantStudio12K Flex OA thermal cyclers and two (2) Absolute Q thermal cyclers, a total of 11 instruments, all manufactured by ThermoFisher Scientific and located at BTD.

The contractor is expected to provide annual preventative maintenance (PM) visits for each year of the contract. The contractor will also provide emergency repairs to contracted equipment within two (2) business days from the time a service call is placed. All services shall be conducted in conjunction with ISO 17025 standards by a trained and certified engineer. Moreover, the contractor shall furnish instrument performance verification reports to the COR within one week following completion of each onsite service call. For additional parts and labor required outside standard planned maintenance, the contractor will only charge the government at their prevailing rates.

A subset of these 11 PCR machines are located inside BL-3 containment (one of each type: ViiA7, QS12K Flex and Absolute Q). In order to set up annual service of these instruments, the COR must verify that the BL-3 laboratory will be in a “cold” status (i.e., decontaminated to microbiological sterility) at the time of the contractor’s scheduled visit to BTD. Upon scheduling the service, DPG- and BTD-specific visitor permission forms need to be filled out. The DPG form is filled out by the contractor and provides access through the DPG front gate and out to the BTD laboratories and must be submitted to the COR at least one week in advance of the service visit. The required BTD forms are 1) a Risk Assessment Form “Maintenance Annual Risk Assessment for Surety and Non-Surety Biological Laboratories.” This form is filled out by the COR and submitted to the BTD Risk Management Group at least 2 weeks prior to the service visit, and 2) an annual respiratory medical clearance (Mask Form, available from BTD). The Mask Form is filled out by the contractor and is submitted to the COR. A medical doctor must assess that the contractor is in generally good health, sign the form, have it scanned and emailed to the COR at least 2 weeks prior to the scheduled service visit.

Upon arrival, the contractor must attend a general BTD and Dugway safety brief (presented by the BTD Risk Management Group). After donning personal protective equipment (PPE provided by BTD: gloves, lab coat, goggles), the contractor will be given a BL-3-specific safety brief by a Personal Reliability Program (PRP) employee prior to BL-3 laboratory entry. The PRP employee will then escort the contractor into the BL-3 suite and remain with him/her until service is complete and both individuals can exit. This PRP employee is also known as the “GEM”, as defined in the QASP, or as the Technical Point of Contact, below.

The Risk Assessment and Mask Forms are good for a period of one year, as is the general safety brief.

In the special case of an emergency repair of a PCR thermal cycler in an actively “hot” BL-3 laboratory, the required PPE will be more stringent (gloves, booties, scrubs top & bottom, lab coat, googles and a powered air purifying respirator or PAPR). Exit from the “hot” BL-3 laboratory requires a shower and change back into street clothes. Any required tools needed for the emergency service must be non-porous and easy to decontaminate. If decontamination of the tool is not possible (e.g., in the case of a sensitive electronic sensor), the Risk Management Group will consider how to proceed with decontamination on a case-by-case basis.

6 General Requirements The servicing technician must be trained and certified to service Viia 7, QuantStudio12K Flex OA and Absolute Q thermal cyclers in accordance with ISO 17025 standards. A security clearance will not be required.

7 Non-Personal Services The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of servicing technician’s employer to manage their employees and guard against any actions that are in the nature of personal services, or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Procuring Contracting Officer (PCO) immediately.

8 Business Relations The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification and resolution. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of contractor personnel.

9 Contract Administration and Management The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor must maintain continuity between the support operations at BTD and the contractor's corporate offices.

The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact with the Government.

The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience as required to meet these PWS requirements. The contractor shall make necessary travel arrangements for employees. The contractor shall provide necessary infrastructure to support contract tasks.

Contractors may add subcontractors to their team after notification of the Contracting Officer (KO) or Contracting Officer’s Representative (COR).

10 Location and Hours of Work Accomplishment of the tasks in this PWS requires work at BTD. Normal workdays are Monday through Thursday except US Federal Holidays. Workers typically work ten (10) hours per day, forty (40) hours per week, 0700 to 1730. The technical point of contact and COR are expected to be available during core hours.

11 Performance Requirement Summary (PRS)

STD = Standard contract statement AQL = Acceptable Quality Level

12 Special Requirements This section describes the special requirements for this effort. The following sub-sections provide details of various considerations of this effort.

Security and Safety DD Forms 254: Overarching security requirements and contractor access to classified information shall be as specified in the basic DD Form 254, as required. All contractor personnel with access to unclassified information systems, including e-mail, shall have at a minimum a favorable National Agency Check.

Public Release No test data, reports or documents shall be released to other organizations unless authorized in writing by the Contracting Officer, assigned COR through the designated Operational Applications Directorate (OAD) and the OPSEC Coordinator. Any information (classified or unclassified) pertaining to this contract shall not be released for public dissemination. Proposed public releases shall be submitted for approval prior to release to: Engineering Directorate, ATTN: DEVCOM CBC Security Office, 8198 Blackhawk Road, Aberdeen Proving Ground, MD 21010.

Foreign Personnel In accordance with restrictions required by Executive Order 12470, the Arms Export Control Act (Title 22, United States [US] Code [USC]) (Sec 275), the International Traffic in Arms Regulation (ITAR), or Department of Defense (DoD) Directive 5230.25, Withholding of Unclassified Technical Data from Public Disclosure, no foreign persons will be permitted to work on a contract without notifying the Contracting Officer.

Non-US Personnel: If the non-US person is employed/used for contract performance, the company must have a Technology Control Plan (TCP) in place to inform the Government Contracting Activity (GCA)/Defense Security Service (DSS)/Cognizant Security Office (CSO) of what they will do to protect the technology and prevent "unauthorized disclosure." If the Company discloses, exports, deemed-export or otherwise released the technology, remedies can, and most likely will be enforced through State Department export violations. DoD 5220.22-M, National Industrial Security Program Operating Manual (NISPOM) 10-509 apply.

Access and General Protection/Security Policy and Procedures Contractor and all associated sub-contractors employees shall comply with applicable installation, facility, and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also 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 as directed by DOD, HQDA and/or local policy. In addition the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual or facility change, the Government may require changes in contractor security matters or processes. For contractors that do not require a CAC, but require access to a DoD facility or installation: contractor and all associated subcontractor employees shall comply with adjudication standards and processes using the National Crime Information Center Interstate Identification Index (NCIC- Ill) 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 procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

Access to Government Information Systems Contractor personnel will not have access to any government unclassified or classified email information systems, nor to any other unclassified or classified information. A US government security clearance will not be required. DOD Information Assurance Awareness training will not be required.

Handling or Access to Controlled Unclassified Information The contractor shall not disclose or release the content of any government software, procedures or information provided to the contractor to other than government authorized persons or activities.

Privacy Act All information obtained, generated or maintained by the Contractor or their Subcontractors under this contract will be the property of the US Government and subject to the requirements of the Privacy Act of 1974 as amended and all local, site, DISA and DOD security regulations.

Safeguarding Government Information and Property The contractor shall be responsible for safeguarding all government information and property provided for contractor use. The contractor shall safeguard information and material designated as classified, unclassified sensitive, For Official Use Only (FOUO), Operations Security (OPSEC) sensitive, Personally Identifiable information (PII) and Privacy Act Information in accordance with applicable directives.

Loss or Possible Compromise of Classified Information The contractor shall immediately report the loss or possible compromise of classified information or material to the COR and OAD Security Manager.

13 Safety Contractor and associated sub-contractors shall provide a safe and healthful work environment for their employees as prescribed in FAR 52.236-14, 29 CFR Part 1910, pertinent provisions of AR 385-10, and local regulations, policies, and SOPs. They shall safeguard public and government personnel, property, and equipment, and avoid interruption of Government Operations. The Contractor will report accidents or losses to the KO as specified in relevant regulations and standards. Whenever the Contractor becomes aware of serious or imminent danger to Government, civilian or Contractor personnel, the Contractor shall take immediate corrective action.

14 Transition If the selected contractor is different from the immediate past contract performer of these or similar tasks, they shall follow the transition plan submitted as part of their proposal and keep the Government fully informed of status throughout the transition period. Throughout the phase-in/phase-out periods, it is essential that attention be given to minimize interruptions or delays to work in progress that would impact the mission. The contractor must plan for the transfer of work control, delineating the method for processing and assigning tasks during the phase-in/phase-out periods.

15 Environmental Requirements The contractor shall comply with all documents listed below as mandatory and referenced under Section 5 Scope and Section 11 Performance Requirements. Compliance with documents listed as non-mandatory is at the contractors' option.

Mandatory compliance (list): N/A Non-Mandatory document (list): N/A

16 Quality This section describes the Quality Control components for this effort.

The Contractor shall develop and maintain an effective quality control program (QCP) to ensure services are performed in accordance this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The QCP is the means by which the contractor knows that the work complies with the requirement of the contract.

The finalized QCP will be accepted by the Government at the time of the award of the Task/Delivery Order. The Contracting Officer may notify the Contractor of required modifications to the plan during the period of performance. The Contractor then shall coordinate suggested modifications and obtain acceptance of the plan by the Contracting Officer. Any modifications to the program during the period of performance shall be provided to the Contracting Officer for review no later than 10 working days prior to effective date of the change. The QCP shall be subject to the Governments review and approval. The Government may find the QCP "unacceptable" whenever the Contractors procedures do not accomplish quality control objective(s). The Contractor shall revise the QCP within 10 working days from receipt of notice that QCP is found "unacceptable."

17 Government Inspections, Audits, Surveys, and Requests for information.

In accordance with FAR 52.246-5, the contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires. The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all places and times during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work. If any of the services performed do not conform to contract requirements, the Government may require the contractor to perform the services again in conformity with contract requirements, for no additional fee. When the defects in services cannot be corrected by re-performance, the Government may (1) Require the contractor to take necessary action to ensure that future performance conforms to contract requirements; and (2) Reduce any fee payable under the contract to reflect the reduced value of the services performed. If the contractor fails to promptly perform the services again or take the action necessary to ensure future performance in conformity with contract requirements, the Government may (1) By contract or otherwise, perform the services and reduce any fee payable by an amount that is equitable under the circumstances; or (2) Terminate the contract for default. "Services", as used in this clause, includes services performed, workmanship, and material furnished or used in performing services.

The contractor shall respond to all requests for information and technical advice regarding the services in this contract. Responses shall be either verbal or written, as specified by the requester. Types of action shall include:

a. Responding to inquiries and suggestions.

b. Providing written comments based on review of draft documents such as regulations that affect the operations in this contract.

c. Providing information requested by customers, investigators, inspectors, auditors and members of special teams (both internal and external to BTD) and responding to findings of such inquiries.

d. Preparing reports in accordance with government instructions and directives by the requested due dates.

e. Attending on-site and off-site meetings as required by the Government.

18 Quality Assurance Surveillance Plan (QASP) The Government shall monitor the Contractors performance under this Task/Delivery Order in accordance with the Government QASP.

19 Government Furnished Property (GFP) Reference Material; Information, Data, Equipment, Hardware, and Software All government furnished reference material; information, data, equipment, hardware, and software provided to the contractor for task order performance under this contract, remain the property of the US Government. The Government will provide space on-site needed to conduct work for the duration of the period of performance under this contract. However, if no space is available contractor personnel shall perform support at the contractor site. The contractor shall sign a hand receipt/property list for all equipment provided by the Government. Rejection of GFP by the Contractor shall not relieve the contractor of responsibility in performance of this contract. The contractor shall not use property provided by the Government for any purpose other than the performance of this contract.

As soon as the GFP is no longer required it shall be promptly turned in. The COR will specify the method the GFP will be turned in.

Management of GFP.

The contractor shall manage GFP in accordance with Parts 45 and 52 of the FAR. The contractor shall be liable for shortages, loss, damages, or destruction of Government property in accordance with the property clauses in Section I of the contract and the Financial Liability Investigation. Within 15 calendar days of discovering the item is missing, damaged or destroyed, the contractor shall appoint a point of contact who is responsible for initiating the Financial Liability Investigation.

For any contractor working in a Government facility, the following shall be provided:

Telephone Service The Government will provide telephone communication service exclusively for the conduct of official business. The contractor shall be responsible for charges for long distance telephone calls made or accepted by contractor personnel, which are not for the purpose of conducting official government business. The contractor shall be responsible for long distance telephone calls and charges made by or accepted by contractor personnel that are not required for the performance of the mission. The Government-furnished telephones are subject to security monitoring at all times. Use of these telephones constitutes consent to security monitoring.

Network Access The Government will provide network access for all Government issued computer systems required for the conduct of official business in the performance of the contract. Coordinate network access requirements with the COR.

Custodial and Refuse Services The Government will provide custodial and refuse services for the Government facilities used in performance of this contract. Government provision of custodial and refuse services does not relieve the contractor of the responsibility for keeping work areas in a clean and sanitary condition. In some areas, the contractors shall be required to empty trash from office/shop trashcans to dumpsters.

Copying, Printing, and Reproduction The Government will provide shared-use copy machines for limited copying of official reports, documents, and correspondence to accomplish the requirements of specific tasks.

20 Contractor-Furnished Property and Services The contractor shall furnish all necessary supplies, parts, materials, tools, support equipment, labor and vehicles required to perform all operations required by this contract, except for those items or services specifically stated as GFP. Contractor-furnished equipment shall be maintained at all times in a safe and serviceable condition in accordance with the manufacturer recommendations. Maintenance of contractor-furnished equipment will not be performed on Government property or at government expense. The COR or designated representative may inspect the contractors equipment at any time and direct the removal of any unsafe or objectionable equipment from the installation. All contractor-furnished equipment shall be operable and shall meet all local, state, federal, and environmental requirements.

Personal/Contractor-Owned Property The contractor shall ensure that personal/contractor-owned property brought on Government work sites is clearly marked as such to preclude misidentification as Government property. Additionally, the contractor shall ensure that personal/contractor-owned property meets safety specifications as set forth by OSHA and the U.S. Army. The contractor shall ensure that all personal/contractor-owned property is removed at the end of the performance period. All personal/computer IT equipment shall be scanned and checked by Government IT personnel before equipment can be connected to any Government network.

21 Information Security and Intellectual Property The contractor may be required to access data and information proprietary to another Government agency, another Government contractor, or of such a nature that its dissemination or use other than as specified would be adverse to the Governments interest. The contractor or contractor employees shall not divulge or release data or information developed or obtained under this contract except to authorize Government personnel or upon written approval of the COR. The contractor shall not use, disclose or reproduce proprietary data that bears a restrictive legend. The contractor shall obtain written permission of the originator prior to releasing any information. Under Title 18, Sections 793 and 798, the contractor and the contractor employees are liable for any improper release. The contractor shall direct to the COR all inquiries, comments, or complaints arising from matters observed, experienced, or learned as a result of, or in connection with the performance of the contract, the resolution of which may require the dissemination of official information.

Inquiries that the contractor receives for information relative to the Freedom of Information Act (FOIA) shall be directed to the COR for evaluation. The Government retains the authority to release or deny access to the information. The contractor shall be responsible for search and submission of records under the contractor’s control upon Government request.

All work including but not limited to intellectual property and data rights produced under this contract is the sole property of the Government.

22 Smoking Policy The contractor shall comply with AR 600-63 that establishes policies governing smoking in Government facilities and ranges.

23 Lost and Found Property If item(s) are found that do not belong to the contractor, the item(s) shall be turned in to the COR.

24 Deliverables The contractor shall provide the deliverables described as performance standards in sections 11 and 12 and in accordance with the acceptable quality levels.

25 Related Documents The following publications are applicable to the overall performance of this PWS. The contractor is required to adhere to the most current version of any of the published regulations found below. Army, State and Federal regulations are publicly available on the internet. Other publications can be obtained by contacting the Contract Specialist for an electronic version.

Department of Defense Directives (DoDD) 5000.1, the Defense Acquisition System, 12 May 2003.

DoDD 8000.1, Management of DoD Information Resources and Information Technology, 20 March 2002.

DoDD 5000.2-R, Mandatory Procedures for Major Defense Acquisition Programs (MDAPs) and Major Automated Information System (MAIS) Acquisition Programs, 12 May 2003.

Army Regulation (AR) 25-3, Army Life Cycle Management of Information Systems.

AR 73-1, Test and Evaluation Policy, 30 May 2003.

Department of Army (DA) Pamphlet 73-7, Test and Evaluation Software Test and Evaluation Guidelines.

MDA System Capability Specification.

GMD Capabilities Document (GCD).

National Defense Authorization Act Section 234 AR 381-11 Intelligence Support to Capability Development AR 385-10 The Army Safety Program AR 700-127 Integrated Product Support Army Universal Task List (AUTL) ATEC PAM 73-21 Modeling and Simulation Verification, Validation, and Accreditation Methodology ATEC Regulation 73-1 System Test and Evaluation Policy ATEC Regulation 73-21 Accreditation of Models and Simulations for Test and Evaluation DA PAM 385-16 System Safety Management Guide DA PAM 385-30 Mishap Risk Management DA PAM 5-11 Verification, Validation, and Accreditation of Army Models and Simulations DA PAM 73-1 Test and Evaluation in Support of Systems Acquisition MIL-STD 882E System Safety TOPM 73-182 System Test and Evaluation Policy Universal Joint Task List (UJTL)