B.08 Combined Synopsis_Solicitation Opera Phenix Plus.docx

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Original Issue Date: 03 February 2021

2. Close Date: 18 February 2021 10:00 AM EST

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702.

4. Requiring Activity: U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), 1425 Porter Street Fort Detrick, MD 21702.

5. Subject: Brand Name Opera Phenix Plus High Content Screening System

6. Solicitation Number: W81XWH-21-Q-0022

7. Description of Requirement: The Molecular Biology Division (MBD) of USAMRIID has a requirement for an Opera Phenix Plus High Content Screening System. The system consists of a High Throughput Automated Microscope, Air and Water Objectives, Instrument Software, Instrument Installation, User Training, Instrument Warranty and Preventative Maintenance (PM).

7.1. This is a combined synopsis/solicitation issued as a Request for Proposal (RFP) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

7.2 This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-04; effective 19 January 2021.

7.3. This acquisition is Brand Name only. The North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument Manufacturing with a Size Standard of 1000 employees. This requirement is solicited on an unrestricted basis and is NOT set aside for small businesses.

7.4. Contract award shall be made on a competitive best value basis using Tradeoff procedures.

7.5. The Contract Line Item Numbers (CLINs) and items, quantities, units of measure and descriptions are identified under the Supplies/Services Section of the RFP.

7.6 The anticipated required delivery dates are as follows:

Opera Phenix Plus System - 26 March 2021 for the Opera Phenix Plus High Content Screening System.

Extended Warranty and Preventative Maintenance Option #1 – 26 March 2022 – 25 March 2023 Extended Warranty and Preventative Maintenance Option #2 – 26 March 2023 – 25 March 2024 Extended Warranty and Preventative Maintenance Option #3 – 26 March 2024 – 25 March 2025

7.7. Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at 52.212-3 Offeror Representations and Certifications – Commercial Items with its proposal.

8. Point of Contact: The Point of Contact (POC) for this acquisition is Mr. Brandon Roebuck, Contract Specialist, brandon.m.roebuck.civ@mail.mil. No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Proposals

9.1 Proposals shall be prepared in accordance with (IAW) this solicitation and FAR provision 52.212-1, Instructions to Offerors – Commercial Items including the Addendum which is included within the Contract Clauses Section.

9.2. All proposals shall be evaluated IAW the Evaluation Criteria identified in the Addendum to FAR 52.212-2 Evaluation – Commercial Items within the Contract Clauses Section.

9.3. The FAR clause 52.212-4 Contract Terms and Conditions – Commercial Items applies to this acquisition. Additional contract requirements and terms and conditions are identified in the attached RFP.

9.4. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

9.5. The Government reserves the right to reject any or all proposals, and to award no contract at all, depending on the quality of the proposal(s) submitted and the availability of funds.

9.6. Questions: Questions shall be submitted via e-mail to Mr. Brandon Roebuck, Contract Specialist, brandon.m.roebuck.civ@mail.mil no later than 11 February 2021 at 10:00 AM Eastern Standard Time (EST). Questions received after this date will not be accepted. An Amendment to the solicitation will be posted to https://beta.sam.gov/ with responses to the questions received. Only one (1) set of questions per Contractor will be accepted. No telephone calls will be accepted.

9.7 Proposals: Proposals in response to this solicitation are due via e-mail no later than 18 February 2021 at 10:00 AM EST to Mr. Brandon Roebuck, Contract Specialist, brandon.m.roebuck.civ@mail.mil.

9.8. The Offeror shall agree to honor proposed prices for 60 calendar days from the due date for receipt of proposals.

PERFORMANCE WORK STATEMENT (PWS)

USAMRIID Opera Phenix Plus High Content Screening System, Installation, Training, Extended Warranty and Preventative Maintenance

SECTION 1: PURPOSE

1.1. Introduction. Research conducted at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) leads to medical solutions—therapeutics, vaccines, diagnostics, and information—that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command.

1.2. Mission. The USAMRIID’s mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

1.3. Background. Since 1969, the USAMRIID has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. While the core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. USAMRIID is required to modernize the IT equipment that supports our Scientific Research Enclave (SRE), due to the results of an ARCYBER Inspection and equipment going End of Life and End of Support.

1.4. Scope. The contractor shall provide a Brand Name Opera Phenix Plus High Content screening system. The contractor shall provide their standard commercial installation, training, extended warranty and preventative maintenance services.

1.5. Organizational Conflict of Interest (OCI) (Attachment 1, Deliverable 1). The USAMRDC has categorized all service requirements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating OCI in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating or could propose on within the next year. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist USAMRDC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, Common-Off-The-Shelf procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

This requirement is categorized as CATEGORY 3: PRODUCT SUPPORT

1.5.1. It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists, the Contractor shall propose a Mitigation Plan (Deliverable 2) that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

1.5.2. Non-Disclosure Statement (NDS) (Attachment 2, Deliverable 3). The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by this contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2: GENERAL REQUIREMENT

2.1. PERFORMANCE

2.1.1 Place of Performance. All work performed in accordance with the PWS shall be performed for USAMRIID at 1425 Porter Street, Fort Detrick, MD 21702.

2.1.2. Period of Performance. The Opera Phenix Plus High Content Screening needs to be in place no later than 27 March 2021. Installation of Opera Phenix Plus should take three (3) days to complete and integration of the Opera Phenix Plus with the existing system and servers should take two (2) days to complete.

2.1.2.1. After the end of the base year warranty coverage, extended warranty and preventative maintenance coverage is needed for the Opera Phenix Plus System for the following three (3) years. Installation and implementation of all the equipment as well as the warranty and preventative maintenance services are required to be completed by the OEM or any authorized distributors.

2.1.2.2. Basic user training requirements will be during the installation and integration of the hardware.

2.1.2.3. Service Hours. Contractor personnel shall perform services during USAMRIID’s core hours of operation, 0800 to 1700 Eastern Time, Monday through Friday, except U.S. Federal Holidays.

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

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

New Year’s Day, 1 January

Martin Luther King’s Birthday, 3rd Monday in January

President’s Day, 3rd Monday in February

Memorial Day, last Monday in May

Independence Day, 4 July

Labor Day, 1st Monday in September

Columbus Day, 2nd Monday in October

Veteran’s Day, 11 November

Thanksgiving Day, 4th Thursday in November

Christmas Day, 25 December

2.1.2.5. Contractor shall not report to work on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the Installation Commander for any other reason. During these periods of closure, the contractor employees that are not designated as essential IAW this requirement shall not report for work nor shall they be compensated for those days.

2.1.2.6. Telecommuting. Telecommuting is not feasible for the services provided in accordance with this PWS. Equipment maintenance services shall be performed on-site.

2.1.2.7. Work During Emergency Situations.

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

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

2.2. NON-PERSONAL SERVICES:

2.2.1. This performance work statement (PWS) identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that 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 Contractor Officer (KO) immediately.

2.2.2. Severable/Non-Severable Services. This requirement identifies services that are severable in nature.

2.2.3. Inherently Governmental Functions. This requirement has been reviewed and contains no services that are inherently governmental functions, as defined in FAR Part 2.1.

2.2.4. Acquisition Functions Closely Associated with Inherently Governmental Functions. This requirement has been reviewed and contain no services that are closely associated with inherently governmental functions.

2.2.5. Personnel Conduct. The COR, with the approval of the KO, may require the contractor to remove from the Institute any employee working under this contract for reasons of misconduct or security, or found or suspected to be under the influence of alcohol, drugs, or other incapacitating agents. Contract employees will be subject to dismissal from the premises upon determination by the COR and the KO that such action is in the best interest of the Government.

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

2.3. CONTRACT MANAGEMENT:

2.3.1. Government Management. The COR will serve as the primary point of contact for all activities and issues that occur under the contract.

2.3.1.1. The COR will assist in resolving performance issues; initiate and coordinate contract-level changes; notify the KO of any disputes, performance issues, or contractual issues that cannot be resolved at the COR level; and conduct other activities as specified by appointment.

2.3.1.2. The COR has specific technical, functional and oversight responsibilities. The assigned COR will serve as the official point of contract for coordination for the contract; approve or disapprove contractor invoices; review and accept or reject all contractor technical deliverables; monitor funds obligated and disbursed; conduct surveillance by uploading a monthly report in the Procurement Integrated Enterprise Environment (PIEE), Surveillance and Performance Monitoring (SPM); and, conduct other activities as may be specified by the COR appointment letter.

2.3.3. Contract Administration.

2.3.3.1. 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 between the Government and Contractor personnel assigned to support the contract. The Contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on the requirement.

2.3.3.2. The KO will have overall responsibility for administering the contract. The KO is the only person authorized to obligate the Government and make changes to the contract. The KO will manage contract administration and ensure COR responsibilities are being performed.

2.3.3.3. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

2.4. Training Requirements

2.4.1. Completion of Training Requirements (Deliverable 4). The contractor shall track and complete refresher training to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each affected contractor and subcontractor personnel to the COR within five (5) calendar days after completion of training by all personnel and subcontractor personnel. Contractor shall track and complete refresher training to maintain training compliance and readiness status as required.

2.4.1.1. Anti-Terrorism (AT) Level 1. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled-access areas shall complete AT Level I awareness training within 30 calendar days after the contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within five (5) calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

SECTION 3: PERFORMANCE REQUIREMENTS

3.1. The system shall be capable of providing the following features and system requirements based on Minimum Essential Characteristics (MEC):

3.1.1. Allows the combined use of 375 nanometers (nm) and the 425nm excitation lasers or the 405nm laser. The 375/425 laser combination is especially suited for Cyan Fluorescent Protein/Yellow Fluorescent Protein (CFP/YFP) Fluorescence Resonance Energy Transfer (FRET) applications.

3.1.2. Can be equipped with up to three (3) PerkinElmer proprietary high numerical aperture (NA) automated water immersion objectives of different magnifications (=20x, NA 1.0; 40x, NA 1.1.; 63x, NA 1.15).

3.1.3. Automatically corrects for objective offsets using a quasiperiodic grid when used with optional PreciScan automated prescan/rescan routine.

3.1.4. The high content screening system is required to be compatible with (able to export the captured images automatically as part of an image acquisition protocol) the current USAMRIID owned image analysis system (PerkinElmer Columbus Image Storage and Analysis System).

3.1.5. The high content screening system is required to be compatible with the operating system (both for data transfer and utilization of the existing image analysis protocols) to allow USAMRIID to transfer the existing data archive to the new system and to allow new imaging analysis protocols to be applied to existing imaging data to mine additional features from the achieved data. The current operating system is PerkinElmer Operetta CLS High-Content Analysis System utilizing PerkinElmer Harmony High Content Analysis Software.

3.1.6. The high content screening system is required to able to export its own analysis protocols (including 3 voxel-based protocols) into the PerkinElmer Columbus Image Storage and Analysis Software for larger scale analysis.

3.2 The Contractor shall complete initial installation to include:

3.2.1 Installation of Opera Phenix Plus System

3.2.2 Integration of Opera Phenix Plus with Denso Robot

3.2.3 Integration of Opera Phenix Plus with Liconic Incubation

3.2.4 Installation of the Spotfire Software

3.2.5 Setting the Server for Spotfire Software to Access the Data

3.2.6 Installation of client instances on two additional computers that access Spotfire

3.2.7 Integration of Opera Phenix Plus with existing Opera, Operetta, Columbus and Spotfire

3.2.8 Migration of existing data from decommissioned system to new system

3.2.9 Provide Opera Phenix Basic User Training

3.3. The Contractor shall provide the Base Period Opera Phenix System Preventative Maintenance (PM)

3.4. The Contractor shall provide three (3) Option Periods for the Opera Phenix Plus Extended Warranty and Preventative Maintenance (PM) Package.

3.5 By monitoring the Contractor, the COR will determine whether the performance levels set forth in the order have been attained. Performance standards are specified in the following Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level columns.

Opera Phenix Plus System Initial Installation

3.2

Project Acceptance Letter (PAL); explicitly state each system interaction required for the integration of the Opera Phenix Plus System

Base year Opera Phenix Plus System Extended Warranty and Preventative Maintenance

3.3

a) PM scheduled as per contract

b) Opera Phenix Plus System meets performance requirements/specifications

Option Years 1-3 Opera Phenix Plus System Extended Warranty and Preventative Maintenance

3.4

b) Opera Phenix Plus System meets performance requirements/specifications

PM service summary documentation by COR

NOTE: When Contractor has provided each deliverable identified in the above table, the Contractor shall present a Project Acceptance Letter (PAL) to the customer for signature. The deliverables are deemed accepted upon the earlier of: (i) production use of the deliverables, or (ii) ten (10) business days after delivery of the deliverables, unless the customer provides written notice with specific identification of the reason for rejection of the Services Deliverables; this acceptance is not dependent upon any remaining deliverables or services.

3.6. Quality Assurance Surveillance Plan. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specifies the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4: SPECIAL CONTRACT REQUIREMENTS

4.1. Government Furnished Property (GFP). Any applicable Government Furnished Equipment determined to be necessary in the performance of the required services shall be identified at the time of contract award. All government furnished equipment shall be used only for direct support of the services requested in this PWS. The Contractor shall not install any software on government-furnished equipment, unless approved by the Pentagon and KO prior to installation. There is currently no GFP identified for this requirement.

4.2. Security and Safety

4.2.1. Access and general protection/security policy and procedures. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.2.2. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

4.2.3. Prior to commencement of services, the contractor shall provide the COR, within seven (7) calendar days in advance of the event, full names, date of birth, place of birth and Social Security numbers (or equivalent identification numbers for non-U.S. citizens) of all personnel who will be entering Army-controlled installation and facilities.

4.2.4. The contractor shall ensure that its personnel entering Army-controlled installations or facilities have obtained access badges and passes IAW facility regulations and that these badges and passes are obtained in advance so as not to delay the accomplishment of contracted services. The contractor shall contract COR or designated Government Trusted Associate Sponsorship System (TASS) Trusted Agent who is responsible to facilitate and sponsoring contractor’s Army Knowledge Online (AKO) registration and TASS in-processing and out-processing, to include approval, rejection and re-verification.

4.2.5. Force Protection Condition (FPCON) impact on work levels. The contractor workforce shall comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, Headquarters Department of the Army (HQDA), and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON at any individual facility or installation change, the Government may require changes in contractor security matters or process. IAW Department of Defense Instructions (DoDI) 2000.16, DoD AT Standards, the FPCON is defined as follows:

4.2.5.1. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher the Terrorist Threat Conditions (THREATCONS) resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

4.2.5.2. FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

4.2.5.3. FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

4.2.5.4. FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this THREATCON is declared as a localized condition. See also anti-terrorism

4.2.5.5. During FPCONs Charlie and Delta, non-essential services are discontinued. Designated essential service will resume when the FPCON level is reduced to level Bravo or lower.

4.2.5.6. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the contracting officer via the appropriate COR.

4.3. Security Requirements.

4.3.1. Unclassified Contract Security Requirements: The contractor shall ensure all personnel performing under this contract have a favorable National Agency Check with written inquires (NACI), including a favorable completion of Federal Bureau of Investigation (FBI) fingerprint check, which the COR will coordinate with the United States Army Garrison (USAG) Fort Detrick Security office prior to performance start date. The security requirements shall be maintained for the life of the contract, and citizenship shall be verified by presenting an original birth certificate, a U.S. passport, or the original Naturalization Certificate to the USAG Fort Detrick Security office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues shall be reported to the COR, ACOR (if applicable), and USAG Fort Detrick Security Office.

4.3.2. Generation, handling and storage of classified material. The contractor shall not generate, possess or store classified information or material for this contract; therefore, level of safeguarding required is not applicable to this contract.

4.4. Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

4.4.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, HIPAA IAW applicable statutory, regulations, local policies and procedures.

4.4.2. All data received, processed, evaluated, loaded, and created because of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the contracting officer grants specific exception.

4.4.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.4.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.5. Visitor Group Security Agreement. The contractor shall sign a Contractor Visitor Group Security Agreement to protect Government information involved in performance under this contract. The agreement shall outline responsibilities in the following areas: contractor security supervision; standard practice procedures; access, accountability, storage, and transmission of and other responsibilities, as required.

SECTION 5 DELIVERABLES

5.1 Deliverables. The contractor shall provide the following deliverables

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Applicable Directives.

6.1.1. The contractor shall comply with all documents referenced under Section 3, Performance Requirements.

SECTION 7 DEFINITIONS AND ACRONYMS

7.1 Definitions

7.1.1. Contractor. 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.

7.1.2. Contracting Officer. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.3. Contractor Officer’s Representative (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.4. Defective Service. A service output that does not meet the standard of performance associated with the Performance Work Statement.

7.1.5. Deliverable. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

7.1.6. Physical Security. Actions that prevent the loss or damage of Government property.

7.1.7. Quality Assurance. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.8. Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.9. Subcontractor. One that enters into a contract with a prime contractor. The Government does not have any contractual interactions with the subcontractor.

7.1.10. Work Day. The number of hours per day the contractor provides services IAW the Contract.

7.1.11. Work Week. Monday through Friday, unless specified otherwise.

7.2. Acronyms

Quality Assurance Surveillance Plan for USAMRIID Opera Phenix Plus High Content Screening System, Installation, Training, Extended Warranty and Preventative Maintenance

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored?

· How monitoring will take place?

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: TBD Organization or Agency: US Army Medical Research Acquisition Activity (USAMRAA) Telephone: Phone: TBD Email: TBD

b. Contracting Officer’s Representative (COR) – The COR is located at the U.S. Army Aeromedical Research Laboratory. The COR will be responsible for technical administration of this contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

COR: TBD

Telephone: TBD Email: TBD

3. CONTRACTOR REPRESENTATIVES:

The following employee of the contractor will serve as the contractor’s Program Manager for this contract.

Program Manager: TBD Title: TBD Telephone: TBD Email: TBD

4. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

Table 1. Performance Requirements

1. Opera Phenix Plus System Initial Installation

3.2

Project Acceptable Letter (PAL); explicitly state each system interaction required for the integration of the Opera Phenix Plus System

2. Base year Opera Phenix Plus System Extended Warranty and Preventative Maintenance

3.3

b) Opera Phenix Plus System meets performance requirements/specifications

3. Option Years 1-3 Opera Phenix Plus System Extended Warranty and Preventative Maintenance

3.4

b) Opera Phenix Plus System meets performance requirements/specifications

PM service summary documentation by COR

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

· Direct Observation

· 100% Inspection

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

· DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

6. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Example 1:

7. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Performance Assessment Meetings.

The COR shall inspect once a year, at a minimum, after calibration and shall take periodic measurements as specified in the AQL column of the Performance Standards Summary Matrix.

PERFORMANCE REPORT

1. Contract Number: TBD

2. Prepared by: COR Name Entered At Time of Award

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.>

Prepared by: COR

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: TBD

2. To: (Contractor Task Manager or on-site representative)

3. From: TBD

4. Date and time observed discrepancy:

5. Discrepancy or Problem:

<Describe in detail. Identify any attachments.>

6. Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned not later than < # days after receipt of this

CDR. >

Prepared by: COR

Received by:

The COR may initiate a CDRE at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.

MINIMUM ESSENTIAL CHARACTERISTICS (MECs)

Title: BRAND NAME OPERA PHENIX PLUS HIGH CONTENT SCREENING SYSTEM REQUEST FOR PROPOSAL MECS

Requiring Activity/Agency Name: U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The USAMRIID has served as the Department of Defense’s (DoD) lead laboratory for medical biological defense research. While the COR mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions that benefit both military personnel and civilians.

Program Name: HIGH CONTENT SCREENING SYSTEM

1. PURPOSE: The Molecular Biology Division (MBD) of USAMRIID has a requirement for a Brand Name Opera Phenix Plus High Content Screening System. The system consists of a High Throughput Automated Microscope, Air and Water Objectives, Instrument Software, Instrument Installation, User Training, Instrument Warranty and Preventative Maintenance (PM).

2. ESSENTIAL CHARACTERISTICS

The Government’s Minimum Essential Characteristics (MECs) are outlined below

1. Allows the combined use of 375 nanometers (nm) and the 425nm excitation lasers or the 405nm laser. The 375/425 laser combination is especially suited for Cyan Fluorescent Protein/Yellow Fluorescent Protein (CFP/YFP) Fluorescence Resonance Energy Transfer (FRET) applications.

2. Can be equipped with up to three (3) PerkinElmer proprietary high numerical aperture (NA) automated water immersion objectives of different magnifications (=20x, NA 1.0; 40x, NA 1.1.; 63x, NA 1.15).

3. Automatically corrects for objective offsets using a quasiperiodic grid when used with optional PreciScan automated prescan/rescan routine.

4. The high content screening system is required to be compatible with (able to export the captured images automatically as part of an image acquisition protocol) the current USAMRIID owned image analysis system (PerkinElmer Columbus Image Storage and Analysis System).

5. The high content screening system is required to be compatible with the operating system (both for data transfer and utilization of the existing image analysis protocols) to allow USAMRIID to transfer the existing data archive to the new system and to allow new imaging analysis protocols to be…