A03 Request for Information Illumina NextSeq 2000 Maintenance (23 May 2024).pdf

Request for Information (RFI)

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Medical Readiness Systems Biology Branch (MRBB)

Subject: Preventative Maintenance support services for the Illumina NextSeq 2000

This Request for Information (RFI)/Sources Sought (SS) Notice is for market research, information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of WRAIR-MRBB

This market research is seeking sources only that have the authority and ability to provide preventative maintenance services for the Illumina NextSeq 2000. The NAICS code for this requirement is 811210 Other Electronic and Precision Equipment 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: 10 June 2024 10am Eastern Standard Time (EST)

Instructions to Responders:

Review the attached DRAFT PWS. Respondents should address how they best can fulfil the requirements set forth in section 6 of the 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

• 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 of 811210

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

All responses are due no later than 10 June 2024 10:00 AM EST. The requested information shall be submitted via email. The point of contract for this action is Jalyn 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.

mailto:jaclyn.p.svincek.civ@health.mil

DRAFT

PERFORMANCE WORK STATEMENT

JUN 22

PERFORMANCE WORK STATEMENT (PWS)

Illumina Maintenance

9 May 2024

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 preventative maintenance services of an Illumina NextSeq2000 sequencing platform.

1.2 Background:

The Walter Reed Army Institute of Research (WRAIR) provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations.

Through both times of peace and war, infectious diseases have killed, sickened, and disabled far more Service Members than bombs and bullets. WRAIR has created a model of vaccine and therapeutic development that is unique, nimble, and responsive to dynamically evolving infectious disease threats of military importance. WRAIR, with its unparalleled expertise, facilities, and international network, has developed many vaccines and drugs in use today by military and civilian medicine around the globe.

In addition to protecting against infectious disease threats, WRAIR conducts basic and applied research that promotes psychological resilience, enhances neurological functioning, and improves operational readiness among U.S. Service Members. By using a continuum of research from basic science to applied field studies, WRAIR creates innovative solutions to enhance Service Members’ resilience and recovery. Research in military psychiatry and neuroscience has been an integral part of WRAIR's portfolio for more than 70 years. WRAIR researchers are recognized leaders in operational medical research for the military in a number of fields, including brain trauma, blast exposure, deployment stressors, and sleep management.

The WRAIR Medical Readiness Systems Biology (MRSB) Branch delivers cross-disciplinary scientific solutions to enhance military health, performance, resilience, and readiness. MRSB is a disease-agnostic program that utilizes high-throughput, multi-omics, big data crunching platforms supported by a suite of cutting edge, targeted assay tools, artificial intelligence (AI) and machine learning (ML)-empowered analytical capabilities. MRSB is committed to developing a seamless, integrative module enabling the interrogation of genome-to-phenome landscapes to inform medical interventions and develop products to improve the warfighters wellness, performance, resilience, and readiness.

1.3 Scope/Period of Performance:

1.3.1 Scope: The Contractor shall provide non-personal service(s). This requirement is to procure an instrument service plan for Medical Readiness Systems Biology’s Illumnia NextSeq 2000 sequencing platform. The NextSeq 2000 sequencer allows MRSB to perform small whole genome sequencing, targeted gene sequencing, exome sequencing, and other analyses necessary to identify biomarkers of military relevant diseases and conditions. MRSB acquired the NextSeq2000 in July 2023, and the one-year warranty and preventative maintenance is expiring. This equipment is proprietary to the manufacturer and highly complex; thus, servicing of the equipment by other means than the manufacturer is inadvisable. The Contractor shall perform on-site maintenance, annual maintenance, operational qualification, and replace reagents due to instrument failures. The object of this requirement is to provide MRSB with expanded coverage for their sequencing platform to ensure maximal functionality and rapid repairs if necessary.

1.3.2 Period of Performance:

The Period of performance for this requirement shall be as follows:

Base Period: 13 September 2024 – 12 September 2025 Option 1: 13 September 2025 – 12 September 2026 Option 2: 13 September 2026 – 12 September 2027 Option 3: 13 September 2027 – 12 September 2028 Option 4: 13 September 2028 – 12 September 2029

1.4 Objectives: Provide annual maintenance, emergency repairs, parts, labor, and remote monitoring in accordance with the manufacturer’s tiered maintenance plans.

1.5 General Information:

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.

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

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 workday prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer.

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 between 0600-1800 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 0600-1800 Monday through Friday 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, or administrative closings.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support between the hours of 0600 and 1800 Monday through Friday. In the event of emergency repairs or maintenance, the Contractor shall respond in accordance with the standards in Section 5. The Contractor shall always maintain an adequate workforce, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.4.3.1 Contractor Work Plan: Reserved.

1.5.5 Training Holidays: Reserved

1.5.6 Place of Performance: The work to be performed under this contract will be performed at the 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, Army Regulation (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. Government issued access badges shall not be worn outside designated facilities where visible to the general public.

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 Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer 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 Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. 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 Contracting Officer 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.

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

1.13 Contractor Travel: Reserved.

1.14 Other Direct Costs (ODCs): Cost type CLINs under this contract will be invoiced as ODCs. The Contractor shall manage and account for all costs associated with requirements labeled as ODCs, not to exceed the price ceiling listed in this contract.

1.14.1 Invoices: The contractor shall submit invoices monthly to Wide Area Workflow (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 Other Direct Costs (ODCs).

Backup information for ODCs shall list all elements of costs. All ODCs exceeding $3,000 requires the contractor to 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.

1.15 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 Contracting Officer. 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.

1.16 Non-Disclosure Requirements: Reserved

1.17 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.

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

1.18 Non-Disclosure Statements: Reserved

1.19 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.001).

1.20 Phase In /Phase Out Period: Reserved

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

1.21.1 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)).

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

(a) Before initiation of work at the job site, an Accident Prevention Plan, written by the Contractor for the specific work and hazards of the contract and implementing in detail the pertinent requirements of EM 385-1-1; will be reviewed for acceptance by designated Government personnel. Specific requirements for development of the Accident Prevention Plan are found in 01.A and Appendix A of EM 385-1-1. EM 385-1-1 is available online at www.usace.army.mil (A.002)

(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 fifteen calendar days after award of the contract. Plans for subsequent major phases of work shall be submitted no later than fifteen 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.

1.21.1.2 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.

1.21.1.3 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.

1.21.1.4 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.

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

1.22.1 Environmental Compliance Plan and Program Reserved

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

1.23.1 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.003).

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.003).

1.23.2 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.004).

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.004).

1.23.3 iWATCH Training: Reserved

1.23.4 Information Assurance (IA) Training Reserved

1.23.5 Personally Identifiable Information (PII): Reserved

1.25 Notice to Proceed: Reserved

1.27 Government Property and Services: 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 Contracting Officer 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, Contracting Officer’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 Contracting Officer 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 Contracting Officer 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 similar to 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 an end 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 similar to Level 3 in a Work Breakdown Structure.

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

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

Work Week - Monday through Friday, unless otherwise specified.

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

ACOR Alternate Contracting Officer's Representative AI Artificial Intelligence AOD Administrative Officer of the Day AFARS Army Federal Acquisition Regulation Supplement AHA Activity Hazard Analysis AOR Area of Responsibility AR Army Regulation AT Anti-terrorism ATCTS Army Training Certification Tracking System CAC Common Access Card CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative DA Department of the Army DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense FAR Federal Acquisition Regulation GFP Government Furnished Property HIPAA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness ID Identification IGCE Independent Government Cost Estimate IT Information Technology KO Contracting Officer MD/MDS Medical Devices/Medical Devices Systems ML Machine Learning MRSB Medical Readiness Systems Biology OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OEM Original Equipment Manufacturer

OSHA Occupational Safety and Health Administration OPSEC Operations Security PII Personally Identifiable Information POC Point of Contact PTSD Post Traumatic Stress Disorder PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RA Requiring Activity SIGE Safety and Health Protection Plan

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: The Government will provide the training in Section 1.21 above.

3.8 Common Access Cards (CAC): Reserved

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The contractor shall furnish all parts, labor, equipment, personnel, and transportation to and from WRAIR in accordance with their provided Tiered Maintenance Plan outlined in Section 5 of this PWS.

4.2 Secret Facility Clearance: Reserved

4.3 Materials: Refer to section 4.1

4.4 Vehicles and Equipment: Refer to section 4.1

4.5 Background Checks: Reserved

PART 5

SPECIFIC TASKS

5.1 Basic Services: The Contractor shall provide services for parts, labor, travel, and service of the Illumina NextSeq 2000 in accordance with their tiered maintenance plans.

5.2 Tasks: Tasks consist of the following:

5.2.1 The contractor shall provide the following:

5.2.1.2. The contractor shall provide reagent replacement upon instrument failures, one annual Preventative Maintenance with one Operational Qualification, Operational Qualification upon major repair, and 24/7 remote technician support.

5.2.1.3. The Contractor shall provide emergency on-site repair services with a 48-hour response time. The Contractor shall provide documentation (e.g., service report) detailing all repair services performed upon completion of services. (A.005)

a) The Contractor shall respond within 48-hours (Monday through Friday).

b) Prior to reporting to a service call, the contract’s services representation shall notify medical maintenance via email (usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil) and shall report in person or telephonically notify the maintenance manager of the building, room number, and telephone number prior to commencing services during normal duty operating hours (0800 to 1600 EST). During other than normal operating hours, the contractor's representative shall report to the Administrative Officer of the Day (AOD) and notify medical maintenance via email.

c) The Government and the Contractor's service representative will exchange hazard communication information before the commencement of any repair.

d) When required, the Contractor's service representative will comply with the Occupational Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance on Medical Devices/Medical Device Systems

(MD/MDS).

e) Upon completion of services by the Contractor's service representative, a service report shall be provided to the COR or the AOD with an electronic copy of the service report submitted 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 MD/MDS malfunction and corrective action taken. It shall include, at a minimum, the time required to complete the work and a list of parts replaced with part numbers prior to leaving the facility. (A.005)

f) In the event all information is not available to the Contractor's service representative when services are performed, the initial service report 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 ten days after services are completed.

g) The Contractor shall have access to all necessary diagnostic software (if applicable). The Contractor shall use only Original Equipment Manufacturer (OEM) new or OEM refurbished repair parts.

h) The Contractor's service representative will be factory trained and have a minimum of two years of experience working on the contracted MD/MDS

i) The Contractor shall furnish all software updates/patches issued by the MD/MDS manufacturer.

j) 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.

5.3 Service Contract Reporting

5.3.1 System for Award Management (SAM) Service Contract Report (SCR): 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 through the following web address: www.sam.gov. Reporting inputs will be for the labor executed during the period of performance during each Government FY, which runs from 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. Contractors may direct questions to the help desk by clicking “View Assistance for SAM.gov” which is located at the top of the SAM.gov website. From there, you can the select “Contact Our Service Desk” which will allow you to contact SAM.gov directly. If contract period of performance ends prior to September 30, the Contractor has 30 calendar days from end date of the contract to complete the SAM SCR requirement. (A.006)

Steps for Submitting a Service Contract Report (SCR)

1. Go to www.sam.gov and log in.

2. Select Entity Registrations and then select Service Contract Reporting.

3. SAM displays your entities which have service contracts and meet the reporting criteria.

Select View by entity to see the service contracts for each entity.

http://www.sam.gov/ http://www.sam.gov/

4. Next, select Add for the service contract against which you want to create a Service Contract Report. Each service contract which meets the FAR Subpart 4.1703 reporting thresholds is displayed.

5. You will be taken to the Complete Service Contract Report page. SAM displays the contract details and allows you to report. You are required to enter the following information:

• Total Amount Invoiced: Total dollar amount invoiced for services performed during the previous Government fiscal year under the contract (this amount should include the prime and any subcontract amount).

• Prime Contractor Hours Expended: Prime contractor direct labor hours expended on the services performed during the previous Government fiscal year. The amount you enter is automatically divided by 2,080 hours to calculate a Full Time Employee (FTE) equivalent, displayed under the Prime Contractor Hours Expended as Prime Contractor FTEs. Report any required Tier 1 subcontractor information by selecting the Add Tier 1 Subcontract Information button.

6. When you are ready to submit the report, select Submit. This saves your report and returns you to the Select Service Contract page where you can create other SCRs or edit an existing SCR.

Steps for Editing a Submitted Report

1. Follow steps 1-4 above. Any previously submitted SCR will have a View/Edit button instead of an Add button.

2. Select View/Edit. You will be able to view the current SCR, edit available fields, and resubmit the record. You can also delete previously entered information altogether.

STD: All information provided by the Contractor shall be accurate, complete, and not exceed suspense dates noted in corresponding paragraph above.

AQL: 100% Compliant

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 5.2.1.3 Provide emergency repair services.

Equipment returned to mission capable based on the manufacturer’s specifications

Meets: >99.9 Does Not Meet:

<99.9%

Direct observation and analysis of contractor reports.

PRS#2 - PWS para 5.2.1.2 Provide scheduled preventative maintenance.

Complete scheduled preventative maintenance, on time and in a timely manner

Exceeds: >99.99%.

Meets:

99.99 - 99.00%.

Does Not Meet:

< 99.00%

Direct observation and analysis of contractor reports.

PRS#3 – PWS para 5.1

The contractor shall exhibit good customer service

Provide all personnel-based services as outlined in manufacturer’s maintenance plan

100% Compliance Zero Deviation from standard

Direct COR Observation

Technical Exhibit B Deliverable Frequency # of Copies Medium/Format Submit To A.001

OCI Mitigation Plan

(Para 1.19)

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.002

Accident Prevention Plan and AHA

(Para 1.21.1)

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

A.003

AT

Certifications

(Para 1.23.1)

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.004

OPSEC

Training Certificates

(Para 1.23.2)

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.005

Service Report

(para 5.2.1.3)

Within 48 hours of service completion

1 Electronic document (MS Word, MS

COR

A.006

SCR

(para 5.3.1)

NLT 31 October each calendar year with last report due within 30 calendar days from end date of the contract

1 Electronic document (MS Word, MS

Sam.gov