LIMS Task Order One.pdf

Food and Drug Administration

Statements of Work For Task Order 1 -

Laboratory Information Management System (LIMS) Laboratory Assessment and Laboratory

Pilots (LALP)

1. Introduction

1.1. Background

1.2. Objectives

1.3. Scope

2. Description of Work

2.1. Laboratory Assessment (Base Task) (T&M)

2.1.1. Requirements Validation Gathering and Analysis

2.1.2. Business Process Modeling and Process Flow

2.1.3. Laboratory Instrumentation Assessment

2.1.4. Integration Assessment

2.1.5. Software Assessment

2.1.6. Network Assessment

2.1.7. Hosting Assessment

2.1.8. Laboratory Instrumentation and User Hardware Recommendations

2.1.9. LIMS Preliminary Design

2.1.10. Roadmap

2.2. Laboratory Pilot 1 (Base Task) (T&M)

2.2.1. Work in Parallel with Functioning Laboratories

2.2.2. LIMS COTS Software and Licenses

2.2.3. Documentation

2.2.4. Laboratory Instrumentation

2.2.5. Network

2.2.6. Hosting

2.2.7. Laboratory Functionality

2.2.8. Briefings with Local Laboratory Director

2.2.9. Internal Reviews

2.3. Laboratory Pilot 2 (Optional Task) (T&M)

2.3.1. Work in Parallel with Functioning Laboratories

2.3.2. LIMS COTS Software and Licenses

2.3.3. Documentation

2.3.4. Laboratory Instrumentation

2.3.5. Network

2.3.6. Hosting

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LIMS Laboratory Assessment and Pilots—Statement of Work

2.3.7. Laboratory Functionality

2.3.8. Briefings with Local Laboratory Director

2.3.9. Internal Reviews

3. Specific Deliverables

3.1. Laboratory Assessment

3.2. Laboratory Pilot 1

3.3. Laboratory Pilot 2 (OPTION)

4. Order Administration Information

1. Introduction

1.1. Background

The Laboratory Information Management System (LIMS) Laboratory Assessment and Laboratory Pilots (LALP) Task Order is the vehicle for building the management framework necessary to achieve the objectives of the LIMS contract.

1.2. Objectives

The purpose of this Task Order is to provide an assessment of all the ORA laboratories (base task), produce a pilot in one laboratory (base task), and a pilot in a second laboratory (optional task). As 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. This Task Order, thus, includes the following activities:

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

• Recommending network and firewall configurations;

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

• Security requirements identification and management;

• 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;

• Integration of the LIMS and any commercial off-the-shelf (COTS) products with FDA enterprise systems to form a LIMS solution;

• LIMS configuration;

• Custom development;

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

• Develop Pilot(s) to help prove technical concepts;

• Providing LIMS Pilots with integration to lab instruments;

• Deployment planning for Pilot(s); and

• Implementation of Pilot(s).

In addition, activities under this Task Order shall promote operational efficiencies and avoid schedule and resource conflicts, especially during the assessment.

1.3. Scope

The overarching goal of this Task Order is to provide an overall LIMS solution that is to be piloted in two of the ORA laboratories and then implemented at all ORA laboratories. This includes all the associated services listed in Section 2. This Task Order is Time and Materials (T&M) per contract section 1.

The scope of this Task Order is to

1. Conduct a Laboratory Assessment, which includes the necessary activities to plan for and design the implementations for all of the ORA laboratories (base task).

2. Execute Laboratory Pilot 1, which includes procuring LIMS licenses and software and producing a Pilot in one ORA laboratory (base task).

3. Execute Laboratory Pilot 2, which includes procuring LIMS licenses and software and producing a Pilot in a second ORA laboratory (optional task).

The Laboratory Assessment includes the activities listed in Section 2.1.

The Pilot or Pilots will be limited to the Microbiology discipline and will show functionality in the areas listed in Section 2.2 and 2.3 below. The results of the Pilot(s) will be used by FDA as inputs into determining whether or not to exercise the following option year and continue development of the LIMS solution with the Contractor.

The laboratory in which the first pilot (base task) will be implemented is the Northeast Regional Laboratory (NRL). Basic information on NRL follows.

NRL, which is located in Jamaica, NY, is one of the FDA’s largest field laboratories. Its staff of scientists is responsible for performing laboratory analysis of the domestic and imported products regulated by the agency. To support this effort, the laboratory maintains strong programs in regulatory methods development research and technical training. The laboratory is accredited by A2LA for technical competence in Chemical and Biological testing in accordance with the recognized international standard ISO/IEC 17025:2005 General Requirements for the Competence of testing and Calibration Laboratories.

The laboratory is organized into three sections: Drug Chemistry Branch, Food Chemistry Branch and Microbiological Sciences Branch. The testing performed includes analysis for microbial pathogens, pesticides, food additives, mycotoxins, colors, insanitation, decomposition and heavy metals in foods, and quality and purity in pharmaceuticals.

The NRL is especially well-equipped. Its array of instrumentation includes highly sophisticated equipment, including a Fourier transform infrared spectrometer with microscopic capabilities and a gas chromatographic interface, a nuclear magnetic resonance spectrometer, mass spectrometers including ICP/MS, LC/MS, GC/MS ion trap and quadrupole and automated microbial screening and identification systems.

The laboratory staff in NRL comprises 128 individuals, all of whom will potentially have access to the LIMS Pilot.

The laboratory for the second (optional task) pilot is the Denver District Laboratory, Denver, CO (DEN).

Basic information about DEN follows.

The Denver Laboratory is co-located with the Animal Drugs Research Center at the Denver Federal Center (DFC) in Denver Colorado. The Denver Laboratory was the first FDA laboratory to be nationally accredited by ISO 17025 standards. It is a member of the Food Emergency Response Network (FERN), a national system of laboratories dedicated to the security of the nation’s food supply and able to respond in the event of a terrorist attack. Additionally, Denver contains a Biosafety Laboratory (BSL), inspected and certified by the Centers for Disease Control and Prevention (CDC), and designed for the isolation of bioterrorism generated Select Agents such as anthrax and botulism.

The Denver District Laboratory is a full service laboratory that tests pharmaceuticals, medical devices, and a wide variety of foods and animal feeds (domestic and imported) for dangerous and illegal analytes such as pathogens (e.g. Salmonella, E.coli), drug residues (e.g. antibiotics), and food additives, using a variety of microbiological and chemical methods. The laboratory consists of seven groups, the Animal Drugs Research Center (ADRC), two Veterinary Drug Sections, one General Chemistry Section and three Microbiology Sections. The Denver District Laboratory has a total staff of 64 employees with 20 chemists (including 3 GS-13 Specialists), 26 microbiologists (including 4 GS-13 specialists), a science advisor, one electronics specialist, management, and support staff.

The laboratory staff in DEN comprises 73 individuals, all of whom will potentially have access to the LIMS Pilot.

The execution of work under this Task Order will build the base necessary to ensure the full and complete implementation of LIMS solution across all of the ORA laboratories.

2. Description of Work This section details the work to be accomplished.

2.1. Laboratory Assessment (Base Task) (T&M)

The FDA has gathered extensive requirements for the LIMS. The requirements that have been gathered, analyzed, validated, and approved by the FDA Office of Regulatory Affairs (ORA) are provided as attachments (Business Requirements Document (BRD), titled “ALM - LIMS BRD”; System Requirements Specification (SRS), titled “ALM - LIMS SRS”; and Requirements Traceability Matrix (RTM), titled “ALM - LIMS Requirements Repository”). Additional summary information regarding the requirements can be found in the attached document titled ORA LIMS Requirements Summary.

ORA requires a LIMS solution that satisfies FDA/ORA's overall workflow assignment tracking, sample collection, sample management, sample chain of custody, analysis, and laboratory management in conjunction with compliance assessment and case management. ORA is not looking for an isolated Laboratory LIMS solution. The Contractor’s solution shall address leveraging existing ORA investments, including currently licensed enterprise software, and interoperability with the existing FDA enterprise systems Regulatory Business Information Services (RBIS), Mission Accomplishment and Regulatory Compliance Services (MARCS), Quality Management Information System (QMIS), and electronic Laboratory Exchange Network (eLEXNET). Other materials have been provided as Attachments for systems such as MARCS and RBIS.

The Contractor shall accomplish the following for the laboratory pilots and for the overall LIMS Solution for the ORA laboratories:

1. Requirements validation gathering and analysis

a. Validate that the requirements are sufficient for the pilots and then all of the additional ORA laboratories and that the requirements are categorized appropriately based on business needs.

b. Address gaps between the attached FDA-provided requirements and the selected LIMS solution.

c. Proceed to further requirement elicitation, analyses, and decomposition as necessary, including detailed requirements for system interfaces and data exchanges with existing systems and programs.

d. Manage requirements in this task.

2. Business Process Modeling and Process Flows: Create Detailed Business Process Models and Process Flows across all 16 laboratories.

3. Laboratory Instrumentation Assessment: Assess the compatibility of current laboratory instrumentation with the proposed LIMS solution.

4. Integration Assessment: Provide an assessment of integration with MARCS, RBIS, QMIS, eLEXNET, and additional interfaces.

5. Software Assessment: Assess whether or not to continue use of current items in ORA, including Electronic Data Capture (EDC), ExcelSafe, Chemical Inventory System (CISPro), the Access-based Inductively Coupled Argon Plasma (ICP) Database Program (IDP), Agilent OpenLab, and other legacy custom applications.

6. Network Assessment: Assess the use of the Business network and the lab network.

7. Hosting Assessment: Assess the architecture regarding centralized and decentralized hosting solutions.

8. Instrumentation and User Hardware Recommendations: Recommendations for laboratory instrumentation and user hardware.

9. LIMS Preliminary Design: Provide a design for the LIMS solution. This includes a design of all necessary infrastructure hardware including middleware hardware for establishing interfaces with other ORA systems.

10. Provide a roadmap for the implementation of a LIMS solution. This roadmap will be a communication tool used to inform stakeholders when various components and features will be available in each laboratory/location, and when the LIMS will be integrated with other ORA systems.

2.1.1. Requirements Validation Gathering and Analysis

2.1.1.1. Requirements Validation

The Contractor shall validate that the requirements are sufficient for the current stage. The Contractor shall do further requirements elicitation, analyses, and decomposition. If any gaps or errors are found in the requirements, the Contractor shall make the necessary corrections. This shall be conducted in two stages:

1. Validate requirements necessary to support work in the Laboratory Pilot 1 (base task) and Laboratory Pilot 2 (optional task) tasks.

2. Validate requirements for the rest of the ORA laboratories and categorize requirements based on business need/priority.

2.1.1.2. Gap Analysis

The Contractor shall perform a detailed gap analysis between the attached FDA-provided requirements and the selected LIMS solution. The Contractor shall address the gaps that are found.

2.1.1.3. Further Gathering and Analysis

The Contractor shall document detailed requirements for system interfaces and data exchange with interfacing systems. The Contractor shall provide use cases for some scenarios to help clarify the requirements. This includes requirements for activities defined in this task.

2.1.1.4. Requirements Management

The Contractor shall continue to manage the requirements on an ongoing basis throughout the project’s life cycle.

The Contractor shall use FDA’s installation of RequistePro. The Contractor shall provide qualified personnel that have adequate knowledge of RequistePro for managing the requirements using the tool.

The Contractor shall document the data requirements. The data requirements are to be captured in a logical data model and data dictionary in an ERwin model file.

2.1.1.5. Evidentiary Requirements

The Assessment shall evaluate proper support for evidentiary requirements. These include the most recent versions of USC Title 28 - Judiciary and Judicial Procedure (http://www.gpo.gov/fdsys/pkg/USCODE-2009-title28/pdf/USCODE-2009-title28-partV-chap115.pdf), especially §1732–33; and USC Title 28, Appendix, Federal Rules Of Evidence, Article IX, Authentication And Identification, Rules 901–903 (http://www.gpo.gov/fdsys/pkg/USCODE-2009-title28/pdf/USCODE- 2009-title28-app-federalru-dup2-other-dup8.pdf).

2.1.1.6. Preliminary Performance and Capacity Requirements

The Contractor shall provide preliminary performance and capacity indicators about the LIMS solution as follows but not limited to:

1. Min/max transactions per minute,

2. On-line response times per transaction and trends (e.g., provide response to the user in x seconds for ad-hoc reports and x seconds for ad-hoc queries, provide response to the user in x seconds if fewer than y concurrent users are logged in, provide response to the user in x seconds if less than y concurrent users are logged in),

3. Utilization statistics,

4. Business usage trends,

5. Processor and I/O usage trends,

6. Network usage trends,

7. Workload trends and forecasts,

8. Growth forecasts.

These data shall be used for measuring performance of the LIMS solution. Such measurements shall be made in the CHDC Pre-Production environment and in WODC for test environments for Lab Pilots. These requirements then can be incorporated as performance requirements in the SRS. The mobile and MOD laboratories have different throughput and statistics on performance measurements there will differ.

2.1.2. Business Process Modeling and Process Flow

The overarching ORA, high-level BPM is provided as an attachment (titled “Business Process Model”).

The current requirements have been aligned to the processes in the model. A general example of the sample management workflow in the laboratories can be found in the BRD attachment. The Contractor shall further detail the business processes and workflow in the laboratory. This detail will be necessary in order to properly configure the LIMS to meet the needs of each physical laboratory and laboratory type within the physical laboratories. The Contractor shall align the requirements with the processes in the updated, detailed models. The detailed business process models and workflows will capture the “To-Be” state for each laboratory. The final deliverable for this will be a set of To-Be business process flows.

2.1.3. Laboratory Instrumentation Assessment

The Contractor shall assess networking and connecting the scientific instruments to the LIMS. The current list of instruments can be found in the attachment entitled “Lab Instruments.” The Contractor shall provide an assessment of the current laboratory instrumentation with the proposed LIMS solution. The Contractor shall work with LIMS Project Leaders and laboratory staff to determine exactly which of current instruments will be connected to the LIMS and when. The assessment includes interfaces with laboratory instruments across all the ORA laboratories (instrument-specific and laboratory-specific). This also includes middleware implications.

2.1.4. Integration Assessment

The Contractor shall provide an overall assessment of the integration of the COTS LIMS for all ORA laboratories into the FDA environment, especially MARCS, RBIS, QMIS, and eLEXNET.

The Contractor shall provide Decision Analysis Result Reports (DAR Reports) for each of the systems listed below. The Contractor shall update the requirements documentation to reflect the outcome of the FDA-approved DARs.

2.1.4.1. DAR Report for Detailed LIMS-MARCS Integration

The Contractor shall create and present DAR Report(s) to assist ORA to make an informed decision regarding how to best leverage the use of MARCS services and integrate the LIMS solution with MARCS via Web Services. The Contractor shall update the requirements documentation to reflect the outcome of the FDA-approved DAR(s).

The Contractor’s recommendations must demonstrate how well the proposed solution complies with open standards, as listed in the attachment “LIMS Solution Conceptual Architecture, Products, SOA v0.4.” If it does not comply with these standards, the Contractor shall propose an approach in meeting these architectural requirements for MARCS integration.

2.1.4.2. DAR Report for Detailed LIMS-RBIS Integration

The Contractor shall create and present DAR Report(s) to assist ORA to make an informed decision regarding how to best leverage the use of RBIS capabilities and integrate the LIMS solution with RBIS.

The Contractor shall update the requirements documentation to reflect the outcome of the FDA-approved DAR(s).

2.1.4.3. DAR Report for Detailed LIMS-eLEXNET Integration

The Contractor shall create and present DAR Report(s) to assist ORA to make an informed decision regarding how to best leverage the use of eLEXNET capabilities and integrate the LIMS solution with eLEXNET. The Contractor shall update the requirements documentation to reflect the outcome of the FDA-approved DAR(s).

The Contractor’s recommendations must preserve data that is fed into eLEXNET from FDA.

2.1.4.4. DAR Report for Detailed LIMS-QMIS Integration

The Contractor shall create and present DAR Report(s) to assist ORA to make an informed decision regarding how to best leverage the use of QMIS capabilities and integrate the LIMS solution with QMIS.

The Contractor shall update the requirements documentation to reflect the outcome of the FDA-approved DAR(s).

2.1.4.5. Additional Interfaces

The Contractor shall also investigate the construction of interfaces (for example, but not limited to architecture, access control, secure transmission and routing design, archiving). In addition, the Contractor shall investigate the data exchange (data format, standardized terminology, sources, frequency, growth rate) for the system interfaces identified in the non-functional requirements (please refer to the non-functional requirements in the attachment “ALM-LIMS_Requirements_Mgmt_Plan.v1.0,” under Requirements Traceability Matrix, for the list of system interfaces already identified).

2.1.5. Software Assessment

The Contractor shall provide an assessment of the continued use of other software packages currently in use in ORA. The Contractor shall create and present DARs to assist the FDA ORA to make an informed decision to either integrate the LIMS solution with currently existing solutions or replace them with the LIMS features. These are listed below.

2.1.5.1. EDC

Electronic Data Capture (EDC) is a pilot under the ALM program umbrella. EDC stores information contained in FDA Electronic 431 Worksheet related to microbiology data. The objective of the e-431/EDC pilot is to develop a nation-wide system that supports the electronic capture, distribution, and storage of laboratory analytical work package data. The system is developed using FileMakerPro.

2.1.5.2. ExcelSafe

ExcelSafe is a pilot under the ALM program umbrella. ExcelSafe provides audit and quality control tools for any MS Excel spreadsheets to be compliant with 21 CFR Part 11. The objective of the ExcelSafe pilot is to develop a system that supports the electronic capture and storage of laboratory analytical work package data. The system is developed using a software product from Ofni Systems called ExcelSafe.

2.1.5.3. CISPro

Chemical Inventory System (CISPro) from ChemSW tracks chemicals supplies and serves as a chemical inventory control enterprise system. This application is a web-based application that performs real time inventory. It is used to reduce procurement costs, meet reporting requirements, eliminate unnecessary purchases, and minimize disposal costs by maximizing the use of available chemical supplies. It is centrally hosted at FDA’s Contractor Hosted Data Center (CHDC) and is used by personnel in all 14 static field laboratories to track the chemicals in their laboratories.

2.1.5.4. KAN-DO Elemental Analysis Laboratory’s ICP Database Program (IDP) The Kansas City Laboratory (KAN-DO) uses an Inductively Coupled Plasma (ICP) Database Program (IDP) while performing elemental analysis. It is a Microsoft Access–based system.

2.1.5.5. HP Agilent OpenLab

Agilent OpenLab will be piloted at the ORA’s Forensics Chemistry Center (FCC) laboratory. OpenLab integrates instrumentation data and analytical data and protects and shares the data within the laboratory.

2.1.5.6. Other Legacy Systems Currently Used in the Laboratories Other legacy custom applications requiring a Decision Analysis Report have been created in VMS UNIX applications, Microsoft Excel spreadsheets, and Access databases.

2.1.6. Network Assessment

The Contractor shall recommend a solution for protecting the instrumentation PCs while having the instrumentation data and system available on the business network. The Contractor will recommend a solution to the question of using a centralized or decentralized (laboratory) design (or some combination of the two).

2.1.7. Hosting Assessment

The Contractor shall assess potential architecture solutions including centralized and decentralized hosting solutions. FDA has two primary data centers. These are the White Oak Data Center (WODC) used for Development and Test and the Contractor Hosted Data Center (CHDC) used for Pre-Production and Production. As the ORA laboratories are geographically dispersed, a decentralized hosting solution is also possible. A solution may also include a combination of both the centralized and decentralized approaches.

2.1.8. Laboratory Instrumentation and User Hardware Recommendations Subsequent to the laboratory instrumentation assessment, the Contractor shall provide nonbinding recommendations for improvements and/or upgrades to laboratory instrumentation and user hardware and instrumentation for use with the LIMS solution. The Contractor shall work in conjunction with DFS on such recommendations.

2.1.9. LIMS Preliminary Design

Based on the Contractor’s other activities in this task, the Contractor shall provide a preliminary design for the LIMS solution. The Contractor shall also provide an overall assessment of the integration of the LIMS solution for all ORA laboratories into the FDA environment.

2.1.10. Roadmap

Once requirements have been structured and approved, the Contractor shall produce a roadmap to organize those requirements into future deployment releases of the LIMS solution, over a quarterly or semi-annual timeline. This roadmap will be a communication tool used to inform stakeholders when various components and features will be available in each laboratory/location, and when the LIMS will be integrated with other systems. The LIMS Roadmap must have development and implementation activities in alignment with the MARCS Roadmap such that the integration is achieved efficiently in relation to the timelines and detailed touch-points of the two systems. All ORA laboratories shall be implemented by the end of FY 2015.

2.2. Laboratory Pilot 1 (Base Task) (T&M)

Laboratory Pilot 1 shall be performed at NRL. The goals of Pilot 1 include the following:

1. The Pilot will not negatively impact anything that is currently working in the laboratory being Piloted.

2. The Pilot will address functionality that supports the processing of microbiology samples.

3. The Pilot will show full instrument integration within the laboratories for the specific equipment enumerated below, pending instrument availability.

4. The Pilot will test the feasibility of placing instrumentation on the best applicable network (assessed under the Lab Assessment portion of this TO under “Network assessment”).

5. The Pilot will utilize the Development and Test environments in White Oak Data Center (WODC).

6. The Pilot will be conducted up through a Test Stage Gate in accordance with the FDA Tailored

EPLC.

7. The Pilot will show that the LIMS solution meets mandatory Priority IV requirements for microbiology.

8. The Pilot will test interoperability with the following MARCS components (if available): Work Assignment and Accomplishment Manager (WAAM); Field Work Manager (FWM); Notification Services (NS); Standardized Evidence and Reference Services (SERS); and Authorization, Roles, and Responsibilities Management Service (ARRMS). The Pilot will also test interoperability with MARCS in the test environment, if available.

9. The Pilot will show the necessary levels of software validation in order to support evidentiary requirements within the test environment.

10. The Pilot will show acceptable system performance.

11. The Pilot will provide a decision point for FDA to determine whether or not to exercise the following option year and continue development of the LIMS solution with the Contractor.

2.2.1. Work in Parallel with Functioning Laboratories

The laboratory in the Pilot is a functioning laboratory that will be conducting production work while the Pilot is in progress. The Contractor shall work in such a manner so as minimize disruption in the production work performed by the laboratory in the Pilot. The Contractor shall also work in such a manner that current processes and procedures in the laboratory in the Pilot are not broken or become inoperable for more than one business day.

Work performed under the Pilot that involves interaction with other FDA contractors must be done in a coordinated manner that does not conflict with activities under the other contracts. This includes MARCS and RBIS.

2.2.2. LIMS COTS Software and Licenses

The Contractor shall acquire the appropriate software and licensing to support the work in the Pilot. This acquisition will be made according to the software and licensing for the Pilot as specified in the Contractor’s proposal.

2.2.3. Documentation

The Contractor shall provide documentation for the Pilot (to include, but not limited to, project management plan, schedules, lessons learned, architecture documentation, interface control document, software validation plans). This documentation should be concise, as full documentation will be delivered under other tasks or Task Orders. Documentation should emphasize successful tests and implementations. In addition, the Contractor shall also provide presentations.

2.2.4. Laboratory Instrumentation

This Pilot includes interfacing the LIMS solution with a specific set of equipment. The Contractor shall interface the LIMS with the instrumentation detailed for each laboratory in the attached spreadsheets (titled Lab Instruments).This includes support for the Quality Management Systems (QMS) procedures for each instrument. The Contractor will gather the relevant QMSs after award from the NRL SME and QMS staff. This includes instrument qualification, operational qualification, and performance qualification. A sample QMS is attached (“DEN Microbiology Environmental Monitoring Procedure”).

2.2.5. Network

The Contractor shall perform a feasibility analysis that shall recommend the best solution for integrating the LIMS with instruments on the business (regulatory) network. There are multiple possible solutions, some of which include the laboratory network, the business (regulatory) network, or some combination of the two. The feasibility analysis shall recommend the best implementation that meets FDA’s business requirements and interoperability with the instruments, other ORA systems, and local laboratory instruments. The feasibility analysis shall include lifecycle costs and performance measurements against requirements. The Contractor shall present the results of the performance testing as applicable for the test environment. The network structure may also include the use of a local network for the storage of scientific information or other appropriate data sets if the design dictates that the network bandwidth is compromised by transmitting large data sets.

FDA will review the results and findings presented by the Contractor and then provide additional direction on the network configuration.

2.2.6. Hosting

The Contractor shall utilize the FDA WODC for hosting the Pilot. The Contractor shall implement the Pilot in the WODC Development and Test environments. This includes the database, application, and web layers. WODC includes FDA-provided hardware. The test tools that the FDA uses are listed in the attachment titled “FDA Test Tools.”

2.2.7. Laboratory Functionality

The Contractor shall install Pilot in the NRL laboratory. The Pilot shall address workflows that focus on microbiology using the workflows from the business process modeling task under the Lab Assessment portion of this TO.

The Pilot shall demonstrate the ability to accommodate the following mandatory Priority IV business processes for microbiology (refer to the Business Requirements Document (BRD), System Requirements Specification (SRS), and Requirements Tracking Matrix (RTM, ALM-LIMS Requirements Repository.xls, column N: “Trace to Business Process”) for more details):

1. Receiving samples

2. Assigning samples

3. Tracking status of samples

4. Returning samples

5. Disposing of samples

6. Prioritizing samples

7. Categorizing samples

8. Storing samples

9. Managing sample inventory

10. Obtaining analysis material, including but not limited to media, reagents, and supplies

11. Preparing samples

12. Analyzing samples

13. Recording analysis results

14. Approving analysis results

15. Tracking analysis metrics

16. Providing specific methodological guidance (access to methods including online resources)

17. Enabling system notifications and alerts

18. Tracking of workflow, including sample chain of custody

19. Maintaining supply information

20. Maintaining laboratory equipment information

21. Maintaining inventory, preventative maintenance, and calibration of instrumentation

22. Maintaining sample and reagent physical storage information

23. Maintaining laboratory human resources capacity information (i.e., people available to do work and their skills/training)

24. Assessing sample analysis capacity

25. Enabling standard and ad-hoc reporting

26. Providing a management dashboard

27. Supporting data export and import

28. Performing contextual searches

29. Ensuring data integrity

30. Archiving data (maintaining record of completed work)

31. Maintaining analysis reference data

32. Maintaining laboratory geographical location information

33. Performing system administration

34. Supporting ISO accreditation (ISO standard 17025)

The scope of the Pilot is to be implemented for one laboratory and shall include the following list of major LIMS functions:

1. Ability to manage user accounts by utilizing ARRMS, if available. This also includes Single-Sign- On (SSO) capability.

2. Ability to manage sample types.

3. Ability to manage laboratory administrative processes.

4. Ability to insert data from integrated laboratory instruments into analyst’s work package data.

5. Ability to print barcodes (requirements from MARCS FWM 2 for samples, if available; CISPro for reagents; and for equipment).

6. Ability to scan barcodes and associate the item with an assignment.

7. Ability to use the data from the barcode to populate fields in the LIMS.

8. Ability to interface effectively with MARCS Work Assignment and Accomplishment Manager (WAAM) for workflows and tracking of work performed in the laboratories on the basis of the results of the DAR for LIMS-MARCS under the Laboratory Assessment task and the consequent decision by the Government. Requirements will be updated based on this result.

9. Ability to check human resource availability to assist in making assignments.

10. Ability to check qualifications and training of the laboratory analysts.

11. Ability to check equipment availability for conducting analyses.

12. Ability to assign work to laboratory analysts.

13. Ability to route automatic email notifications (MARCS services NS).

14. Ability to generate secure worksheets via Microsoft Word.

15. Ability to audit the electronic equivalent of logbooks to ensure proper maintenance and calibration schedules are respected.

16. Ability to maintain inventory levels of instruments.

17. Ability to audit inventory supply levels of reagents and managed substances.

18. Ability to record in an audit trail any change to the sample record by any user.

19. Ability to split samples and maintain the relationships to each other and the original assignment.

This includes tracking samples that were split in MARCS before being sent to the laboratories.

20. Maintain chain of custody and sample analysis, sub-sample, and split information throughout sample lifecycles, including MARCS chain of custody.

21. Ability to handle sample disposition at multiple different physical locations.

22. Ability to relate media preparation assignments to samples (even in the scenario where media are prepared for batch process samples).

23. Ability to generate ad-hoc worksheets: new worksheet templates can be generated for high priority or emergency response methods, allowing data to be captured into the sample record.

24. Ability to support ISO 17025 accreditation for laboratory accreditation.

25. The Pilot shall demonstrate the integration with external systems. This includes an interface with MARCS that demonstrates providing and consuming Web Services. For MARCS, this will show integration with NS, SERS, ARRMS, WAAM, and FWM. This could be realized by the use of a single proxy service for communications with the MARCS service bus. These shall demonstrate the use of the Oracle Security Suite, and the Oracle 11G stack. This also includes an interface for RBIS for shipping data to the data warehouse.

26. The Pilot shall demonstrate proper support for evidentiary requirements. These include the most recent versions of USC Title 28 - Judiciary and Judicial Procedure (http://www.gpo.gov/fdsys/pkg/USCODE-2009-title28/pdf/USCODE-2009-title28-partV-chap115.pdf), especially §1732–33; and USC Title 28, Appendix, Federal Rules Of Evidence, Article IX, Authentication And Identification, Rules 901–903 (http://www.gpo.gov/fdsys/pkg/USCODE-2009-title28/pdf/USCODE-2009-title28-app-federalru-dup2-other-dup8.pdf).

2.2.8. Briefings with Local Laboratory Director

Provide high-level reviews to discuss progress, scheduling, and other issues that may affect the laboratory. These brief reviews should be designed to facilitate the efficient use of laboratory resources, to prevent any disruptions of laboratory work, and to leverage off of unique domain knowledge.

2.2.9. Internal Reviews

The Pilot shall be conducted up through the Test review. The Test review must be accepted by the COTR and the Business Program Manager for LIMS based on how well the implementation fulfills paragraphs 2.1.1–2.1.9 in order to complete the Pilot. The Pilot will incorporate the following reviews:

1. Design

2. Development

3. Test

2.3. Laboratory Pilot 2 (Optional Task) (T&M)

Laboratory Pilot 2 shall be performed at DEN. The goals of Pilot 2 include the following:

1. The Pilot will not negatively impact anything that is currently working in the laboratory being Piloted.

2. The Pilot will address functionality that supports the processing of microbiology samples.

3. The Pilot will show full instrument integration within the laboratory for the specific equipment enumerated, pending instrument availability.

http://www.gpo.gov/fdsys/pkg/USCODE-2009-title28/pdf/USCODE-2009-title28-partV-chap115.pdf

4. The Pilot will test the feasibility of placing instrumentation on the best applicable network (assessed under the Lab Assessment portion of this TO under “Network assessment”).

5. The Pilot will utilize the Development and Test environments in White Oak Data Center (WODC).

6. The Pilot will be conducted up through a Test Stage Gate in accordance with the FDA Tailored

EPLC.

7. The Pilot will show that the LIMS solution meets mandatory Priority IV requirements for microbiology.

8. The Pilot will test interoperability with the following MARCS components (if available): Work Assignment and Accomplishment Manager (WAAM); Field Work Manager (FWM); Notification Services (NS); Standardized Evidence and Reference Services (SERS); and Authorization, Roles, and Responsibilities Management Service (ARRMS). The Pilot will also test interoperability with MARCS in the test environment, if available.

9. The Pilot will show the necessary levels of software validation in order to support evidentiary requirements within the test environment.

10. The Pilot will show acceptable system performance.

11. The Pilot will provide a decision point for FDA to determine whether or not to exercise the following option year and continue development of the LIMS solution with the Contractor.

2.3.1. Work in Parallel with Functioning Laboratories

The laboratory in the Pilot is a functioning laboratory that will be conducting production work while the Pilot is in progress. The Contractor shall work in such a manner so as minimize disruption in the production work performed by the laboratory in the Pilot. The Contractor shall also work in such a manner that current processes and procedures in the laboratory in the Pilot are not broken or become inoperable for more than one business day.

Work performed under the Pilot that involves interaction with other FDA contractors must be done in a coordinated manner that does not conflict with activities under the other contracts. This includes MARCS and RBIS.

2.3.2. LIMS COTS Software and Licenses

The Contractor shall acquire the appropriate software and licensing to support the work in the Pilot. This acquisition will be made according to the software and licensing for the Pilot as specified in the Contractor’s proposal.

2.3.3. Documentation

The Contractor shall provide documentation for the Pilot (to include, but not limited to, project management plan, schedules, lessons learned, architecture documentation, interface control document, software validation plans). This documentation should be concise, as full documentation will be delivered under other tasks or Task Orders. Documentation should emphasize successful tests and implementations. In addition, the Contractor shall also provide presentations.

2.3.4. Laboratory Instrumentation

This Pilot includes interfacing the LIMS solution with a specific set of equipment. The Contractor shall interface the LIMS with the instrumentation detailed for each laboratory in the attached spreadsheets (titled Lab Instruments).This includes support for the Quality Management Systems (QMS) procedures for each instrument. The Contractor will gather the relevant QMSs after award from the DEN SME and QMS staff. This includes instrument qualification, operational qualification, and performance qualification. A sample QMS is attached (“DEN Microbiology Environmental Monitoring Procedure”).

2.3.5. Network

The Contractor shall perform a feasibility analysis that shall recommend the best solution for integrating the LIMS with instruments on the business (regulatory) network. There are multiple possible solutions, some of which include the laboratory network, the business (regulatory) network, or some combination of the two. The feasibility analysis shall recommend the best implementation that meets FDA’s business requirements and interoperability with the instruments, other ORA systems, and local laboratory instruments. The feasibility analysis shall include lifecycle costs and performance measurements against requirements. The Contractor shall present the results of the performance testing as applicable for the test environment. The network structure may also include the use of a local network for the storage of scientific information or other appropriate data sets if the design dictates that the network bandwidth is compromised by transmitting large data sets.

FDA will review the results and findings presented by the Contractor and then provide additional direction on the network configuration.

2.3.6. Hosting

The Contractor shall utilize the FDA WODC for hosting the Pilot. The Contractor shall implement the Pilot in the WODC Development and Test environments. This includes the database, application, and web layers. WODC includes FDA-provided hardware. The test tools that the FDA uses are listed in the attachment titled “FDA Test Tools.”

2.3.7. Laboratory Functionality

The Contractor shall install Pilot in the NRL laboratory and, at the Government’s option, at the DEN laboratory. The Pilot shall address workflows that focus on microbiology using the workflows from the business process modeling task under the Lab Assessment portion of this TO.

The Pilot shall demonstrate the ability to accommodate the following mandatory Priority IV business processes for microbiology (refer to the Business Requirements Document (BRD), System Requirements Specification (SRS), and Requirements Tracking Matrix (RTM, ALM-LIMS Requirements Repository.xls, column N: “Trace to Business Process”) for more details):

1. Receiving samples

2. Assigning samples

3. Tracking status of samples

4. Returning samples

5. Disposing of samples

6. Prioritizing samples

7. Categorizing samples

8. Storing samples

9. Managing sample inventory

10. Obtaining analysis material, including but not limited to media, reagents, and supplies

11. Preparing samples

12. Analyzing samples

13. Recording analysis results

14. Approving analysis results

15. Tracking analysis metrics

16. Providing specific methodological guidance (access to methods including online resources)

17. Enabling system notifications and alerts

18. Tracking of workflow, including sample chain of custody

19. Maintaining supply information

20. Maintaining laboratory equipment information

21. Maintaining inventory, preventative maintenance, and calibration of instrumentation

22. Maintaining sample and reagent physical storage information

23. Maintaining laboratory human resources capacity information (i.e., people available to do work and their skills/training)

24. Assessing sample analysis capacity

25. Enabling standard and ad-hoc reporting

26. Providing a management dashboard

27. Supporting data export and import

28. Performing contextual searches

29. Ensuring data integrity

30. Archiving data (maintaining record of completed work)

31. Maintaining analysis reference data

32. Maintaining laboratory geographical location information

33. Performing system administration

34. Supporting ISO accreditation (ISO standard 17025)

The scope of the Pilot is to be implemented for one laboratory and shall include the following list of major LIMS functions:

1. Ability to manage user accounts by utilizing ARRMS, if available. This also includes Single-Sign- On (SSO) capability.

2. Ability to manage sample types.

3. Ability to manage laboratory administrative processes.

4. Ability to insert data from integrated laboratory instruments into analyst’s work package data.

5. Ability to print barcodes (requirements from MARCS FWM 2 for samples, if available; CISPro for reagents; and for equipment).

6. Ability to scan barcodes and associate the item with an assignment.

7. Ability to use the data from the barcode to populate fields in the LIMS.

8. Ability to interface effectively with MARCS Work Assignment and Accomplishment Manager (WAAM) for workflows and tracking of work performed in the laboratories on the basis of the results of the DAR for LIMS-MARCS under the Laboratory Assessment task and the consequent decision by the Government. Requirements will be updated based on this result.

9. Ability to check human resource availability to assist in making assignments.

10. Ability to check qualifications and training of the laboratory analysts.

11. Ability to check equipment availability for conducting analyses.

12. Ability to assign work to laboratory analysts.

13. Ability to route automatic email notifications (MARCS services NS).

14. Ability to generate secure worksheets via Microsoft Word.

15. Ability to audit the electronic equivalent of logbooks to ensure proper maintenance and calibration schedules are respected.

16. Ability to maintain inventory levels of instruments.

17. Ability to audit inventory supply levels of reagents and managed substances.

18. Ability to record in an audit trail any change to the sample record by any user.

19. Ability to split samples and maintain the relationships to each other and the original assignment.

This includes tracking samples that were split in MARCS before being sent to the laboratories.

20. Ability to split samples and forward an assignment between the two laboratories in the Pilots (Pilot 1 and Pilot 2) for one or more of the sub-samples.

21. Maintain chain of custody and sample analysis, sub-sample, and split information throughout sample lifecycles, including MARCS chain of custody.

22. Ability to handle sample disposition at multiple different physical locations.

23. Ability to relate media preparation assignments to samples (even in the scenario where media are prepared for batch process samples).

24. Ability to generate ad-hoc worksheets: new worksheet templates can be generated for high priority or emergency response methods, allowing data to be captured into the sample record.

25. Ability to transfer a sample between the two laboratories in the Pilot (Pilot 1 and Pilot 2) along with the accompanying data.

26. Ability to support ISO 17025 accreditation for laboratory accreditation.

27. The Pilot shall demonstrate the integration with external systems. This includes an interface with MARCS that demonstrates providing and consuming Web Services. For MARCS, this will show integration with NS, SERS, ARRMS, WAAM, and FWM. This could be realized by the use of a single proxy service for communications with the MARCS service bus. These shall demonstrate the use of the Oracle Security Suite, and the Oracle 11G stack. This also includes an interface for RBIS for shipping data to the data warehouse.

28. The Pilot shall demonstrate proper support for evidentiary requirements. These include the most recent versions of USC Title 28 - Judiciary and Judicial Procedure (http://www.gpo.gov/fdsys/pkg/USCODE-2009-title28/pdf/USCODE-2009-title28-partV-chap115.pdf), especially §1732–33; and USC Title 28, Appendix, Federal Rules Of Evidence, Article IX, Authentication And Identification, Rules 901–903 (http://www.gpo.gov/fdsys/pkg/USCODE-2009-title28/pdf/USCODE-2009-title28-app-federalru-dup2-other-dup8.pdf).

2.3.8. Briefings with Local Laboratory Director

Provide high-level reviews to discuss progress, scheduling, and other issues that may affect the laboratory. These brief reviews should be designed to facilitate the efficient use of laboratory resources, to prevent any disruptions of laboratory work, and to leverage off of unique domain knowledge.

2.3.9. Internal Reviews

The Pilot shall be conducted up through the Test review. The Test review must be accepted by the COTR and the Business Program Manager for LIMS based on how well the implementation fulfills paragraphs 2.1.1–2.1.9 in order to complete the Pilot. The Pilot will incorporate the following reviews:

1. Design

2. Development

3. Test

3. Specific Deliverables

3.1. Laboratory Assessment

Deliverable Description Frequency/Due

Date (in calendar days)

Deliverable to

Task Management Plan

Plan describes the technical approach, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout task execution. The Task Management Plan shall contain a Work Breakdown Structure and Project Schedule.

Draft with proposal Final – 30 days after task award

COTR, IT PM,

Business PM

Updated RTM for the Pilots

The updated RTM contains validated requirements that build on the government provided RTM for the Pilots.

30 days after task award

COTR, IT PM,

Updated RTM

The updated RTM contains validated requirements that build on the government provided RTM for the full implementation.

90 days after task award

COTR, IT PM,

Business PM

Updated SRS for the Pilots

Review the Systems Requirements Specification (SRS) for the Pilots and update as appropriate.

30 days after task award

COTR, IT PM,

Business PM

Updated SRS Review the Systems Requirements Specification (SRS) and update as appropriate for the full implementation.

90 days after task award

COTR, IT PM,

Business PM

Preliminary Performance and Capacity Requirements

Determine expected baseline performances together with recommended levels of capacity.

90 days after task award

COTR, IT PM,

Business PM

Business Process Models (To-Be business process flows) for the Pilots

Recommend business process models for the pilots.

60 days after task award

Deliverable Description Frequency/Due

Date (in calendar days)

Deliverable to

Business Process Models (To-Be business…