Request for Information -Cytometer Performance Maintenance.docx

Request for Information (RFI)

Biologics Research and Development (BRaD) Branch: Walter Reed Army Institute of Research

This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item 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. Responders are solely responsible for all expense associated with responding to this RFI.

RFI Response and due date: 10 November 2023 10:00AM ET

Instructions to Responders:

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

White papers 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.

2. Cover Page (1page)

· Title

· Organization

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

· Topic area(s) addressed.

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.

Please note that responses are due no later than 10 November 2023 10:00AM ET. The preferred method of submission is via email. The point of contact for this action is Ms. Flodean Billings, Contract Specialist flodean.p.billings.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.

DRAFT PERFORMANCE WORK STATEMENT (PWS)

Becton, Dickinson and Company (BD) Flow Cytometer Services for Walter Reed Army Institute of Research (WRAIR), Biologics Research and Development (BRaD) Branch

03 November 2023

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.

The WRAIR Center for Infectious Disease Research (CIDR) combines scientific expertise with product development capabilities to address the full range of diseases of national security importance to the United States (U.S.) military. Moreover, any other battlefield exposures with impact on the immune system are studied. CIDR scientists, along with their collaborators, surveil the incidence and evolution of existing and emerging pathogens around the world to inform combatant commanders of endemic threats to their soldiers. This data is then used to inform and direct product discovery and development efforts.

The Biologics Research and Development (BRaD) Branch within the CIDR is an integrated, broad, translational enterprise spanning discovery science to field efficacy trials. BRaD’s mission is to develop new vaccines and biologics in collaboration with global and U.S. Government partners to reliably prevent malaria infection in military personnel by maintaining robust, expert competency in basic and applied research areas in order to transition candidate products to advanced clinical testing in endemic areas. The Immunology Core within BRaD is a Military Infectious Disease Research Program (MIDRP) funded core capability that stands ready to support any Department of Defense (DoD) researcher with need for immunological or cell biological analysis. Flow cytometry is a powerful tool that has applications in immunology, molecular biology, bacteriology, virology, cancer biology, and infectious disease monitoring. BRaD utilizes BD Flow Cytometer instruments and associated equipment to provide rapid multi-parametric analysis of single cells and particles in solution based on their fluorescent or light scattering characteristics in support of WRAIR’s mission to discover, design, develop, and deliver globally impactful solutions for military relevant infectious diseases, brain health, and performance optimization through innovative research.

1.3 Scope/Period of Performance (PoP):

1.3.1 Scope: The Contractor shall provide non-personal service(s). This shall include providing all labor (e.g., technicians), materials, supplies, equipment, software, tools, travel expenses, parts (excluding consumables), supervision, and other items necessary to perform preventative maintenance services as described in this Performance Work Statement (PWS) and associated contract documents. The Contractor shall perform to the standards and Acceptable Quality Levels (AQLs) identified in this PWS and associated contract documents.

1.3.2 Period of Performance (PoP):

The Period of Performance (PoP) for this requirement shall be as follows:

1.4.1.2 LACSAria (SN: P656700000110): Service coverage shall include one BD Fusion Cytometer instrument with four lasers and one computer workstation and all related components.

The Contractor’s proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within 10 days after contract award.

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 10 days. If the Government has provided comments, the Contractor shall then have five days to submit a final QCP. After receipt of the final QCP, the Contractor may receive the KO’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the KO no later than 30 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance of proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control (QC) team.

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (e.g., timelines, deadlines, and goals).

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the contract, including the contract’s clauses.

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including DoD Contractor Personnel Office (DOCPER) processes/approvals throughout contract performance.

(e) How the Contractor will ensure all keys issued will remain controlled items, if applicable (paragraph 1.7 Key Control).

(f) How the Contractor will inventory, and track maintenance of all Government provided equipment and materials, if applicable.

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future.

(h) How the Contractor will file and save all QC related documents for the life of the contract plus five years.

(A.001).

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

Christmas Day December 25th

1.5.5 Training Holidays: WRAIR has historically granted military personnel training holidays as compensation for time that they spent in field training. These are typically combined with regular holiday leave schedules (e.g., Christmas half days or day-on/day-off schedules). Training holidays may affect access to military operated facilities. If scheduled work or access to facilities is required, coordination with occupants will be necessary, or the work in affected facilities shall be rescheduled before or after the training holiday. However, announced training holidays or exodus of military personnel may provide the Contractor with an opportunity for unrestricted access to facilities and areas. The Contractor shall take full advantage of such opportunities by planning scheduled maintenance and other actions that are better accomplished when such areas are vacant.

1.6 Place of Performance: The work to be performed under this contract will be performed on-site at WRAIR, Building 503, Robert Grant Avenue, Silver Spring, MD 20910. The COR will coordinate with Contractor representatives for any access that may be required at WRAIR.

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

The Contractor shall return installation passes to the issuing IAC office when the contract is completed or when a Contractor employee no longer requires access (A.004).

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 (A.006).

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

1. 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.12 and Appendix A of EM 385-1-1. EM 385-1-1 is available online at www.usace.army.mil (A.008).

1. Before beginning each activity involving a type of work presenting hazards not experienced in previous project operations or where a new work crew or subcontractor is to perform work, an Activity Hazard Analysis (AHA) shall be prepared by the Contractor performing the work activity (see paragraph 01.A.14 of EM 385-1-1) (A.009).

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

1. The Contractor shall discuss the plans in conferences convened by the KO prior to starting work on each major phase of operation. Plans shall include all pertinent information such as layout of haul roads, access roads, storage areas, electrical distribution lines, methods of providing minimum exposure to overhead loads, and methods of access to work areas. The plan for accomplishing the initial work phase shall be submitted within 15 days after contract award. Plans for subsequent major phases of work shall be submitted no later than 15 days prior to initiation of work on each major phase (A.010).

1. 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 boots, and hard hat.

1.19.2 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 (A.011).

If training cannot be conducted on the website, the Contractor shall coordinate with the COR who will contact the local AT Officer (ATO) 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 ATO. Verification of the training shall be provided to the COR within 10 days after completion of the training (A.013).

1.21.2 Operations Security (OPSEC) Training: All Contractor employees, including subcontractors, shall complete OPSEC training within 30 days of employment under this contract. OPSEC training is available at https://www.cdse.edu/Training/eLearning/GS130/. Contractor personnel must complete refresher training every 12 months. Verification of the training shall be provided to the COR within 10 days after completion of the training.

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 10 days after completion of the training (A.014).

PART 2

DEFINITIONS AND ACRONYMS

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

Contracting Officer's Representative (COR) – As defined in Defense Federal Acquisition Regulation Supplement (DFARS) 202.101, means an individual designated and authorized in writing by the KO to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II - Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified IAW 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, TO manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, AR 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the KO as alternate CORs.”

Contractor – means a supplier or vendor awarded a contract to provide specific supplies or services 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 PWS.

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

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

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 WBS.

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 IAW 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.

PART 3

GOVERNMENT PROPERTY AND SERVICES

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

PART 5

SPECIFIC TASKS

1. Two preventative maintenance inspections to be performed during each 12-month period, including two preventative maintenance kits, for each LSRFortessa system to include cleaning and greasing of operational parts.

1. Software revisions released during the agreement term for each LSRFortessa system.

1. One preventative maintenance inspection to be performed during each 12-month period for the HTS (SN:U3386590760200 and SN: R647701001081) including one preventative maintenance kit for the HTS associated with each LSRFortessa system.

1. Replacement of HTS associated with each LSRFortessa system with a certified refurbished unit, if required, to be provided within two days of identified need.

(A.018).

5.2.1.2 LACSAria (SN: P656700000110): Service coverage shall include one BD Fusion Cytometer instrument with four lasers and one computer workstation (excluding printers). Service includes labor, travel expenses, shipping, and parts (excluding consumables) for the following:

1. Two preventative maintenance inspections to be performed during a 12-month period including two preventative maintenance kits.

1. Software revisions released during the agreement term.

1. Pre-contract inspection 30 days prior to the commencement of service coverage to verify instrument is in proper working condition.

(A.018 and A.019).

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

1. Prior to reporting to a service call, the contract’s service representative shall notify medical maintenance via email (usarmy.detrick.medcom-wrair.mbx.medical-maintenance@health.mil) and 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 (0600 to 1800 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.

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

1. 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).

1. 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 will include, at a minimum, the time required to complete the work and a list of parts replaced with part numbers for each part prior to leaving the facility.

1. 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.

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

1. The Contractor must furnish all software updates/patches issued by the MD/MDS manufacturer.

1. 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.

1. For all contracts that require calibration of systems, the Contractor shall complete DD Form 2163 or DD Form 2164 (Verification/Certification Worksheet) IAW the instructions provided in AR 40-61. Additionally, a continuation sheet shall be attached to the DD Form 2164 indicating the manufacturer, model, SN, and date of calibration expiration of all items of Test, Measurement, and Diagnostic Equipment (TMDE) used to perform the calibration.

(A.020).

5.2.3 Technical Support Service: The Contractor shall maintain a high level of availability, with low wait time, to provide customer technical support that includes unlimited interactive telephone and email support for instruments, reagents, and applications for the purpose of responding to questions and resolving technical issues between the hours of 0600-1800 EST, Monday through Friday (excluding U.S. holidays). The Contractor shall provide documentation (e.g., log) detailing all technical support services performed on a quarterly basis (A.021).

5.2.4…