Attachment 1 - LIMS IDIQ SOW.pdf

Attachment 1 - Food and Drug Administration Statement of Work for the Laboratory Information

Management System (LIMS) Indefinite Delivery Indefinite Quantity (IDIQ) Contract

1. Introduction

1.1. Background

1.2. Objectives

2. Constraints

2.1. Technical Standards and Guidelines

2.2. Data Quality Standards

2.3. Laboratory Quality Assurance at ORA

2.4. FDA Standardized Development Environment (SDE)

2.5. Information Technology Investment Management (ITIM)

2.6. FDA Data Centers

2.7. Non-Functional Testing

3. Scope

4. LIMS COTS Software

5. Description of Task Areas

5.1. Program Management

5.1.1. Documentation

5.1.2. FDA SME Requests

5.2. Technical Coordination

5.3. Requirements, Design, Development, Configuration, Testing, and Implementation of a LIMS Solution

5.4. LIMS O&M

5.5. Transition

6. Personnel

6.1. Key Personnel

6.2. Staff Training

Page 1 of 13 March 10, 2011

LIMS IDIQ—Statement of Work

1. Introduction

1.1. Background

The Food and Drug Administration (FDA) collects physical and/or documentary samples of various FDA regulated products or related evidence for laboratory analysis or other examinations to determine whether or not they are adulterated or misbranded, as well as whether they meet quality standards as defined by the Food, Drug, and Cosmetic Act, and related Acts. The results of these physical sample analyses and other activities are reported in a set of documents herein referred to as an analytical work package.

The management and tracking of samples is one of the most critical of FDA’s post market activities. The success of FDA enforcement depends on the ability to provide a complete chain of custody for collected samples and on the ability of the Agency to demonstrate that the results of the laboratory analysis are complete, accurate, and definitively linked to the inspection or investigation which collected them. Over 17 million imported products under the regulatory authority of FDA entered the United States in 2008. To stop distribution of a product that has been judged to be risky, FDA must demonstrate the risk to the public, and that demonstration depends on analyses done by the Office of Regulatory Affairs (ORA) laboratories. Similarly, the ability to successfully stop domestic sale of foods, drugs, or other regulated products that pose a health or safety risk to the public depends on FDA’s ability to present evidence in a court of law.

To provide the necessary evidence, effective sample management (the recording and tracking of data associated with sample receipt, storage, transfers and disposition) is critical and must be subjected to rigorous quality control throughout the analytical process to meet the Agency’s own quality assurance policies which are based on the rules of civil procedure published by the Department of Justice.

ORA operates a total of 14 permanent field laboratories five regional, seven district and two specialized laboratories (forensics and radiochemistry/devices). In addition, the FDA has two mobile laboratories. The individual Centers have 11 laboratories. All laboratories require a range of quality-related attributes such as audit trails and standardization in order to remain accredited or certified by relevant standards organizations. Each laboratory is equipped for certain analysis types (e.g. microbiology, food chemistry, drug chemistry, etc.). Please see the attached documents titled “Laboratory Staff Size,” “ALM - LIMS Requirements Repository,” and “ORA Laboratories Locations and Capabilities” for more information. Currently, laboratory staff members manually enter summary analytical data both on paper and electronically into the Agency’s legacy system (Field Accomplishments and Compliance Tracking System (FACTS)).

Because of the duplicate effort required for data entry, only limited results are shared electronically with other ORA units involved in the regulatory process. Full sample documentation—the analytical package—is transmitted to other ORA components primarily in hard copy or on a Compact Disk – Read Only Memory (CD-ROM). In addition, the current paper-bound practices limit the ability to conduct concurrent analyses of a given sample. Difficulties in sharing data until it has been entered into FACTS prevents participants in the concurrent processing from easily consolidating results and managing the reviews.

As a result of these inefficiencies, large amounts of data from laboratory analyses are not readily available for use outside of the laboratories. With a Laboratory Information Management System (LIMS) solution, however, the data for each sample and its associated analytical results are collected and stored entirely in electronic form, creating a managerial and record-keeping situation that will improve the efficiency of the laboratories. For example, it would increase the efficiency of laboratory staff by providing them with more time for each inspection and grouping laboratory assignments on the basis of similarities. It would also facilitate splitting samples among any number of analysts, whether in the same laboratory or in different laboratories, and thus speed analysis through concurrent handling. The use of a LIMS would also be highly amenable to support ORA initiatives outside of the laboratories. Information could be collected quickly to compare methodologies, to better trace violative goods, and to identify firms engaged in illegal activities, all without needing to request reports from the laboratories.

The LIMS solution will need to be integrated with ORA and other FDA systems, such as Mission Accomplishments and Regulatory Compliance Services (MARCS), Regulatory Business Information Services (RBIS), and other Automated Laboratory Management (ALM) systems, including the Quality Management Information System (QMIS). For instance, MARCS components and services are being developed and maintained under a separate contract that has already been awarded. MARCS will serve as the primary conduit of information between systems regarding inspections of goods and enforcement of FDA policies on domestic and foreign goods, and there is some overlap of functions between a LIMS solution and MARCS. As MARCS services may in some cases be used to satisfy the LIMS project requirements, the LIMS solution will likely be a combination of an integrated suite of configurable Commercial Off The Shelf (COTS) products with some custom development and utilization of some MARCS components and/or services. This overlap of functions must be minimized. Likewise, the overlap of functions between LIMS and RBIS must be minimized.

The use of the phrase LIMS COTS throughout this document refers to a solution which is either a COTS “suite” from a single vendor or a collection of COTS components from multiple vendors and/or custom code which, when fully and efficiently integrated, fulfills FDA enterprise and specifically ORA Laboratory and Field requirements as regards samples, sampling, and sample analysis within legal and scientific controls and parameters.

The use of the phrase LIMS Solution refers to the amalgamation of the entire set of applications (both COTS and custom code), and interfaces that together meet the project’s requirements.

Details on MARCS and its components can be found in the attachments. The LIMS solution is part of a larger ORA workflow and must be part of a comprehensive approach to the FDA regulatory processes.

The FDA anticipates the LIMS solution to support ORA Laboratories’ primary functions listed as:

a) Sample management – where the LIMS solution would assist and/or automate the recording and tracking of data associated with sample receipt, storage, transfers and disposition.

b) Sample analysis – where the LIMS solution would support laboratory analysis work through (1) improving sample analysis throughput and improving support for the management of complex workflows (such as batch process samples with multiple methods to various laboratories), as well as other laboratory operations, including recommending methodologies and offering references to best practices; (2) supporting single sample and batch process sample analysis work, as well as sample splitting; (3) providing online scheduling, assignment of sample analysis, and designation of analyses to be performed, as well as allowing analysts to view online their assigned samples; and

(4) generating template-based reports of the results of a sample analysis.

c) Sample accountability – where the need exists for tracking specimens/samples, control materials and media movement into and out of storage. This function would allow the identification of the location of a specimen/sample at any step in the testing and/or process, resulting in a more efficient sample management with real-time sample tracking and automatic traceability to the appropriate laboratory groups, and laboratory analysts.

d) Electronic document sharing – where ORA Laboratories have a need for cohesive electronic information management to provide information more quickly internally, as well as to other federal agencies, affected states, and the general public.

e) Work process automation and control – where the LIMS solution would assist ORA Laboratories to automate the population of fields in the analytical work packages with information such as methods, analysis, various results, equipment to use, and standards to use.

f) Management of inventories (chemicals, supplies, equipment, staff, etc.) – where the LIMS solution would improve inventory management of such artifacts as manufacture media, reagents, stains, and other supplies and equipment required for support of the individual laboratory analytical testing activity from a variety of components that carry expiration dates. The LIMS solution would support the ORA Laboratories’ staff assignment and work, based on skills, availability and workload.

g) Instrument calibration – where instrument calibration ensures the laboratory equipment will work, and continue to work, as intended. The LIMS solution would support instrument calibration and recalibration in the laboratory when first used. This would include tracking instrument preventive and emergency maintenance, tracking future preventive maintenance dates, and monitoring instrument usage.

h) Instrument data acquisition – where the LIMS solution would make the instrument data available to the user during sample analysis. This will include backup and storage of instrument data for disaster recovery purposes.

i) Asset management – where the LIMS solution would assist ORA Laboratories to manage their assets such as temperature monitoring systems, laboratory specific databases, online reference material, software/hardware licenses, and software/hardware upgrade schedule.

j) Preventive maintenance – where the LIMS solution would assist ORA Laboratories to create records for each instrument and instrument method if multiple methods are used on a given instrument.

k) Training planning and records – where the Laboratory can manage staff training and education activities, personnel resources (including skills, education, certifications, etc.).

Training and education should enable the tracking of course preparation, scheduling, attendance and follow up. Resource management includes tracking employee certifications and competency testing for each test they perform, as well as the instruments they use in testing. This planning capability includes training, documentation, and reporting necessary to maintain ORA Laboratory’s certification. The training records will be maintained in the Quality Management Information System (QMIS). QMIS uses the COTS product Master Control. QMIS is being implemented and maintained under a separate contract. The LIMS solution will need to interface with the QMIS.

l) Reporting, tracking and trending – where the LIMS solution would support timely and efficient general laboratory reports addressing the ORA Laboratories’ external obligations and internal management needs. This function should also enable appropriate statistical analysis, surveillance outputs, and reports needed internally and supplied to external partners for statistical and surveillance purposes.

m) Linking of samples – where the LIMS solution would support data capture and share with other interested parties non-test specific information, allow the performing of additional testing for typing and understanding primary results, and support the performing of statistical analysis activities intended to identify suspicious test request and result patterns.

For more background information please refer to the attachments titled LIMS Boundary Document and LIMS Concept of Operations (ConOps).

1.2. Objectives

The overarching goal of the LIMS contract is to provide, integrate, support, and maintain an overall LIMS Solution that meets FDA requirements and the accomplishes the following objectives:

1. Increase the effectiveness and efficiency of laboratory resources by improving sample analysis throughput and improving support for the management of complex workflows (such as batch processing with multiple methods to various laboratories), and other laboratory operations. This includes settings for two different modes: standard mode and high throughput mode.

2. Decrease sample turnaround time. This includes reducing the manual entry of analysis result data; increasing the efficiency and speed of analytical work package generation and distribution for batch process samples; and improving the ability to scale up production during times of workload spikes.

3. Increase Management ability to track resources more efficiently, including Laboratory equipment, Laboratory personnel, and timeframe issues. This includes the ability to track laboratory work at the individual analysis level.

4. Reduce the opportunity for human errors in data entry, thus improving Quality Assurance in documentation.

5. Improve the capability to generate documentation for accountability by automatically collecting and compiling an electronic audit trail throughout the sample’s life and for analytical work packages.

6. Improve quality control by shortening the time needed to spot check critical parameters and recognize adverse trends.

7. Improve overall trend analysis capabilities, for quality-related trends in laboratory results, for production-related matters (proficiency testing, research, inspections, training, budget, inventory, program obligations), and for performance parameters (time, cost, errors, hours, equipment out-of specifications, sample classifications, responsiveness to consumer complaints and letters). Results will be provided faster, and the accuracy of documents will be improved.

8. Automate laboratory reporting for laboratory-internal and laboratory-external purposes.

This includes automating the collection of readings from instruments and the storage of data (including readings and images) in a queryable database. It may also include storing or accessing chemical storage information to ensure adequate supplies of reagents at a testing site before a test is assigned.

9. Reduce time and effort needed to maintain laboratory accreditation by providing the necessary checks and balances through automated tools and electronic documentation.

10. Streamline communication of other analysis-related information and notifications to stakeholders in FDA’s regulatory work processes.

11. Improve laboratory surge capacity for routine high volume workload and during times of workload spikes.

12. Provide technology to build necessary interfaces with internal and external equipment, systems, and databases.

2. Constraints

2.1. Technical Standards and Guidelines

Current standards and guidelines that must be considered in the execution of this contract include:

1. FDA Tailored Enterprise Performance Life Cycle (EPLC). Refer to the attachment “EPLC Overview for Contracts” for more information.

2. FDA Approved Technologies List - The FDA Master Approved Technology (MAT) List contains a list of approved and not approved technologies including applications (software), infrastructure and peripherals (hardware), and scientific software and devices.

3. FDA Security Authorization Process - Security Authorization is the approach FDA follows to fulfill Federal Information Security Management Act (FISMA), Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) requirements to ensure that information resources have adequate security to protect the Confidentiality, Integrity and Availability of information collected, processed, transmitted, stored, or disseminated by the agency. For further information see: FDA Security Authorization Toolkit (see attachment entitled Security Authorization Toolkit) SP 800-37 Rev. 1: Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach.

4. National Institute of Standards and Technology (NIST) SP800-53 - This publication was developed by the Joint Task Force Transformation Initiative Interagency Working Group with representatives from the Civil, Defense, and Intelligence Communities in an ongoing effort to produce a unified information security framework for the federal government— including a consistent process for selecting and specifying safeguards and countermeasures (i.e., security controls) for federal information systems. SP 800-53 Rev.

3: Recommended Security Controls for Federal Information Systems and Organizations.

5. Federal Information Security Management Act (FISMA)—The E-Government Act (Public

Law 107-347), passed by the 107th Congress and signed into law by the President in December 2002 recognized the importance of information security to the economic and national security interests of the United States. Title III of FISMA requires each federal agency to develop, document, and implement an agency-wide program to provide information security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. Federal Information Security Management Act

(FISMA)

6. NIST The E-Government Act [Public Law 107-347] passed by the 107th Congress and signed into law by the President in December 2002 recognized the importance of information security to the economic and national security interests of the United States.

Title III of the E-Government Act, entitled the Federal Information Security Management Act of 2002 (FISMA), included duties and responsibilities for the Computer Security Division in Section 303 “National Institute of Standards and Technology: NIST: Computer Security Division - Computer Security Resource Center http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05-01-2010.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05-01-2010.pdf http://csrc.nist.gov/groups/SMA/fisma/index.html http://csrc.nist.gov/groups/SMA/fisma/index.html http://csrc.nist.gov/index.html http://csrc.nist.gov/index.html http://csrc.nist.gov/index.html

7. FDA 3250 series of Staff Manual Guide (SMG) policies, as well as HHS security policies. Note: SMG 3251.4 Outsourcing and Third Party Arrangements - The FDA Staff Manual Guides (SMGs) are the Agency directives that document organizations and functions; delegations of authority; and administrative and program policies, responsibilities and procedures.

8. Security Program: Contractor Oversight Guide - Section 2, Defining Contractor

Systems and Related Security Requirements - Information systems subject to Departmental and Federal requirements are predominantly maintained by Department personnel within HHS facilities; however, there exist a substantial number of contractor-run systems. This section clarifies security requirements for these contractor-based systems as well as defines the related roles of contractors and Departmental personnel.

2.2. Data Quality Standards

1. Compliance with FDA standards

The Contractor shall comply with all FDA data standards for consistency, standardization, and the FDA Office of Information Management (OIM) Data and Information Standards and Technology (DIST) group’s guidelines.

2. Support for laboratory accreditation

FDA laboratories are accredited and must maintain this accreditation. The Contractor shall ensure all activities support maintaining International Organization for Standardization (ISO) 17025 accreditation.

3. Support for the evidentiary requirements

The activities performed in the laboratories must conform to the rules that govern proceedings in the courts of the United States. The results produced must be consistent in both process and data so as to be submitted as evidence in both civil and criminal cases. Please refer to USC Title 28 Part V - Procedure, Chapter 115 :Evidence, Documentary, sections 1732 & 1733 and Federal Rules of Evidence, Article IX, Rules 901-903 (in particular 901(b)9.

4. Consistency with MARCS, RBIS, and other ALM Systems

The Contractor shall implement the LIMS solution so the data produced by the system shall provide certain data elements that can be consumed by other systems at FDA. In particular, this deals with information in the areas of user identification and roles, work performed, and time spent on performing work. Other areas may be identified as work progresses.

2.3. Laboratory Quality Assurance at ORA

The Quality Management System is a business program (not an IT system) that focuses on lab quality. The Quality Management Information System is the IT system that supports QMS activities. Each of the 14 static laboratories in ORA has a Quality Manager. The Contractor shall coordinate with the Quality Managers so that LIMS Solution supports quality management activities in the laboratories during the implementation and then later the operations and maintenance of the LIMS. The LIMS Solution must also support the requirements of QMIS.

http://www.gpo.gov/fdsys/browse/collectionUScode.action;jsessionid=MgGmN1HTtbRRtM80jrP9NFHYLqwflVx5szKxT8wgJDSnl3zq0x4J!-1419347784!753855258?collectionCode=USCODE&searchPath=Title+28%2FPart+V%2FCHAPTER+115&oldPath=Title+28%2FPart+V%2FCHAPTER+115&isCollaps http://www.gpo.gov/fdsys/browse/collectionUScode.action;jsessionid=MgGmN1HTtbRRtM80jrP9NFHYLqwflVx5szKxT8wgJDSnl3zq0x4J!-1419347784!753855258?collectionCode=USCODE&searchPath=Title+28%2FPart+V%2FCHAPTER+115&oldPath=Title+28%2FPart+V%2FCHAPTER+115&isCollaps http://www.uscourts.gov/uscourts/RulesAndPolicies/rules/2010%20Rules/Evidence.pdf http://www.uscourts.gov/uscourts/RulesAndPolicies/rules/2010%20Rules/Evidence.pdf

2.4. FDA Standardized Development Environment (SDE)

The Contractor, shall, where applicable, conform to the FDA SDE. A truncated guide to the SDE is included in the attachment is entitled “FDA SDE.”

2.5. Information Technology Investment Management (ITIM)

FDA has instituted the ITIM process in order to track technologies across the agency. The introduction of a new technology or a different version of an already approved technology requires the submission and approval of an ITIM request. The Contractor will be responsible for supporting the ITIM process including writing and submitting ITIM requests and tracking them from inception through completion.

2.6. FDA Data Centers

FDA has two primary data centers. These are the White Oak Data Center (WODC) and the Contractor Hosted Data Center (CHDC). WODC is used primarily for Development and Test environments. CHDC is used for Pre-Production and Production environments. The Contractor will be required to use these four environments in the performance of work.

2.7. Non-Functional Testing

As laboratories are brought online within the LIMS, non-functional testing must be performed each time. The Pre-Production environment at FDA is the designated environment for performance testing. The Contractor shall work with the FDA Performance Testing team to configure tools and schedule personnel and time to conduct required tests.

3. Scope

The LIMS contract encompasses all of the software and services necessary to design, develop, integrate, deploy, operate, and maintain a comprehensive LIMS Solution that meets LIMS requirements and accomplishes the objectives in Section 1.2. The Contractor shall provide all software licenses and maintenance agreements, software documentation, and training materials necessary to implement its solution. The Contractor shall also provide all services, qualified personnel, management oversight, material, development tools and methodologies, subject to approval by the FDA, necessary to provide the LIMS Solution to ORA and other FDA laboratories, integrate it with ORA and other FDA enterprise systems, and maintain it in accordance with the task orders released under this contract.

4. LIMS COTS Software and Software Support

The Contractor shall provide all necessary COTS software, licenses, and full lifecycle support for the LIMS solution. Specific software requirements shall be detailed in this contract’s individual task orders.

The Contractor shall provide full lifecycle support for all of the software that composes the LIMS Solution. This includes, but is not limited to the following:

• User manuals

• System documentation

• LIMS software

• LIMS licenses

• Release notes

• Upgrade support

• Configuration services and documentation

• Technical support

5. Description of Task Areas

5.1. Program Management

The Contractor shall establish the program plans, structures, processes, schedules, reporting requirements, communication channels, and quality control functions necessary to steward the project throughout the contract’s period of performance and fully achieve the objectives of LIMS.

The Contractor shall provide both contract-level and task order level project management to establish control, management, monitoring and notification mechanisms, ensuring that LIMS processes stay on track and important milestones are met.

The Contractor shall provide monthly status reports on all tasks and their progress to the Contracting Officer Technical Representative (COTR) including:

• Status and progress of tasks,

• Cost and schedule variances,

• Coordination activities across tasks,

• Impact or influence of any task on other tasks,

• Impact or influence of tasks on overall FDA program,

• Recommendations for changes or additional activities to ensure that the tasks support progress on the overall LIMS objectives, and

• Contract Earned Value Management (EVM) in accordance with the applicable Tier

Level EVM requirements described in the “HHS EVM Policy” guide.

In addition to progress reporting, the Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Technical Representative of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of the task(s) goals. Recommendations for actions that need to be taken by FDA staff, or other contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.

The Contractor shall also prepare and participate in program/project reviews, stage gate reviews, management briefings, stakeholder presentations and cross-agency information exchanges.

5.1.1. Documentation

The Contractor shall ensure that all system documentation required by the FDA Tailored HHS EPLC management process (see Attachment titled EPLC Overview for Contracts) is complete and up-to-date. The Contractor shall perform Configuration Management (CM) tasks in accordance with the LIMS CM Plan.

5.1.2. FDA SME Requests

The tasks under this contract will require that the contractor engage FDA business Subject Matter Experts (SMEs) in order to understand the FDA business requirements. The Contractor’s requests for engagement shall be provided in a timely manner to give FDA SMEs adequate time to garner ORA business SME involvement. There shall be at least a 1 (one) month lead time for requested ORA business SME engagement. For any meetings involving ORA business SMEs, the Contractor shall provide meeting agendas and materials at least two weeks ahead of the scheduled meetings.

5.2. Technical Coordination

The Contractor shall coordinate activities with FDA OIM and business units. Sample activities include providing support for and conforming to ITIM, defining configurations and capacity requirements for server and network infrastructure, data quality activities, and non-functional testing.

5.3. Requirements, Design, Development, Configuration, Testing, and Implementation of a LIMS Solution

The Contractor shall perform a wide range of IT services necessary to design, develop, integrate, and deploy a LIMS Solution that meets LIMS requirements and accomplishes the objectives in Section 1.2. This includes activities ranging from business process modeling and requirements analysis to COTS configuration, testing, training, and implementation.

The LIMS solution will require configuration to accommodate different business processes and lab instruments particular to individual FDA laboratories and will require integration with other FDA systems. Some custom development is likely to be required. Representative activities include:

• LIMS integration with instrumentation computers and instruments;

• Coordination of activities with FDA OIM and FDA business units;

• Recommending network and firewall configurations;

• Recommending server architecture to support data, application, and web tiers;

• Security requirements identification and management;

• Providing support for security activities and documentation;

• LIMS Requirements analysis and management;

• Business process modeling;

• Workflow process documentation;

• LIMS Solution design;

• LIMS design reviews (i.e. preliminary design);

• Decision Analysis Result (DAR) Reports;

• Integration assessments;

• Detailed LIMS Roadmap;

• LIMS COTS integration FDA enterprise systems;

• LIMS COTS configuration;

• Custom development;

• System testing (unit testing, system testing, integration testing, and user-acceptance testing);

• Developing proofs of concept or prototypes to help prove technical concepts;

• Providing LIMS Pilots with integration to lab instruments;

• Deployment planning;

• Implementation.

5.4. LIMS O&M

The Contractor shall maintain the functionality, reliability, availability, performance, stability, sustainability and security of the LIMS solution including all incorporated software, configurations, integrated services and interfaces, workflows, customizations, and components. Tasks shall encompass the complete lifecycle of activities required for operations and maintenance including but not limited to issue identification, tracking, analysis, and resolution to code generation, testing, and documentation. The Contractor shall maintain, support and evolve designs, documentation, customizations, reports and process automation such as scripts, templates, and workflows. The Contractor shall analyze and report on the impact of infrastructure, connectivity, capacity and other changes to the LIMS environment. Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements and quality measures.

LIMS O&M also includes the day-to-day activities such as system administration and oversight necessary to ensure that ORA Laboratories’ systems and equipment perform their intended functions. Representative activities include:

• System maintenance including system backup and issue resolution;

• System administration;

• Maintenance of documents;

• Performance monitoring and tuning;

• Release Management;

• Maintenance of production code (including the implementation of minor Change

Control Board (CCB) approved code fixes);

• Continuity of Operations Plan (COOP) and support;

• Risk Assessment and Management;

• Maintenance of security accreditation;

• Data quality assurance;

• Support of system hardware and infrastructure upgrades;

• Configuration management;

• Tier 2/3 Help Desk support and issue tracking;

• User training;

• Laboratory instrument computer support: Laboratory instrument computers include computers that are used as instrument controllers separate from the actual instrument and stand-alone instruments. The primary focus of this activity is to coordinate the hardware and software maintenance with the manufacturers of the instruments.

5.5. Transition

The Contractor shall facilitate the transition of development and O&M activities for the LIMS solutions to the Federal Government or a follow-on Contractor at the end of the period of performance. Representative activities shall include:

• Providing the FDA with current versions of all system and user documentation;

• Providing FDA all licensing and renewal information, software documentation, and training materials;

• Providing FDA with a current inventory of all Government-owned assets used by the

Contractor along with full support in the reconciliation of this inventory;

• Providing FDA with current versions of all CONOPS, operational procedures, standard operating procedures, guidelines, performance reports, specifications for hardware and software, and other pertinent information needed to continue the services being performed by the Contractor; and,

• Providing “shadowing” and other knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

• Providing full source code sets (not COTS source code) with configuration management information.

6. Personnel

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to this task order.

6.1 Key Personnel

6.1.1 The Contractor is responsible for providing personnel with the management, technical and subject matter expertise required to accomplish the activities and prepare the deliverables identified in this Statement of Work.

6.1.2 The descriptions and qualifications for each labor category are included in Attachment 4 “Labor Categories”. Personnel that exceed the Government’s minimum requirements will become the applicable Government standard and will be the established standard for contract performance.

6.1.3 The key personnel specified in this order are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the advance, written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

The following are considered key personnel:

Name Labor Category Title

Program Manager

Senior Systems Architect

Subject Matter Expert - LIMS

6.1. Staff Training

The contractor shall ensure that all personnel are trained and have attained the knowledge necessary for the performance of the client requirements. No additional training funds will be allocated in the budget, unless changes to the Government Enterprise Architecture (EA) standards require knowledge of products not currently defined.

7. Access to Non-Public Information

All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information Agreement FDA 3398 prior to commencement of work. The Contractor will be invited to meet with key FDA representatives to review current activities and status, Project Management repository contents, current policies, procedures, plans and charters, and any other materials and discussion deemed relevant to the subject areas described in this Statement of Work (SOW). Additional discovery and relevant materials can be made available to the Contractor as needed to support execution of Task Orders as they are awarded.