LIMS Task Order Two.pdf

Food and Drug Administration

Statement of Work For Task Order 2 -

Laboratory Information Management System (LIMS) Program Management and Technical

Coordination and Operations and Maintenance

1. Introduction

1.1. Background

1.2. Objectives

1.3. Scope

2. Description of Work

2.1. Project management and Technical Corodination

2.1.1. Contract Level Program Management

2.1.2. Technical Coordination Activities

2.1.3. Task Management

2.1.3.1. Create and Maintain Project Plans

2.1.3.2. Maintain Task Mapping Matrix

2.1.4. Meetings

2.1.4.1. Meeting Summaries and Agendas

2.1.4.2. Ad hoc meetings

2.1.4.3. Weekly Status Meetings

2.1.4.4. In-Progress Review (IPR) Meetings

2.1.4.5. FDA SME Requests

2.1.5. Reporting

2.1.5.1. Monthly Reporting

2.1.5.2. Earned Value Management (EVM) Reporting

2.1.5.3. Integrated Baseline Review (IBR)

2.1.6. Documentation

2.1.6.1. Create and Maintain FDA tailored EPLC Documentation

2.1.6.2. Support the Creation and Maintenance of Security Artifacts

2.1.7. Configuration Management

2.1.8. Risk Management

2.1.9. Communications with Stakeholders

2.1.10. Laboratory Quality Assurance

2.2. Operations and Management (Optional)

2.2.1. Training and Support

2.2.2. Training

2.2.2.1. Training Materials

2.2.2.2. Training the Trainer for the Pilot

Page 1 of 17 April 7, 2011

LIMS PMTC and O&M—Statement of Work

2.2.2.3. Environment and Live Support for the Pilot

2.2.3. Support

2.2.3.1. Laboratory Instrumentation Computers

2.2.3.2. Laboratory Instrumentation Computers Maintenance Services

2.2.3.3. Security Maintenance of Laboratory Equipment

2.2.3.4. Laboratory Network Firewall Maintenance

2.2.3.5. Help Desk

3. Deliverables

3.1. Project Management and Technical Coordination

3.2. Operations and Maintenance (Option)

4. Order Administration Information

1. Introduction

1.1. Background

The Laboratory Information Management System (LIMS) Program Management and Technical Coordination (PMTC) and Operations and Maintenance (O&M) Task Order is the vehicle for building the management and operational framework necessary to achieve the objectives of the LIMS contract.

1.2. Objectives

The purpose of this Task Order is to provide program and project management and technical coordination (base task), and operations and maintenance (optional task) services for all Task Orders released under the LIMS contract.

The primary objectives of the PMTC task (base task) are to ensure alignment of activities with key goals and objectives of the LIMS contract, promote operational efficiencies, avoid schedule and resource collisions, and provide Food and Drug Administration (FDA) Management greater visibility into ongoing efforts and resource usage.

The O&M task (optional task) encompasses the full spectrum of IT systems that support LIMS reporting, analysis and the sample collection custody chain and 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 under which they were collected Sample data and 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. This requires that a low-cost but highly effective O&M solution is set up that ensures reliable, available and maintained up-to-date servers, network devices, desktops, and handhelds and smart phones. This will include a Help Desk.

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 Firm Fixed Price (FFP) per the description in Section 1 of the contract.

The Contractor shall provide the full range of program management and technical coordination (PMTC) (base task) services necessary to successfully achieve the objectives of the LIMS contract. This includes all the associated activities listed in Section 2.1. The work consists of recurring activities in areas such as program planning, coordination, and scheduling; communications with FDA stakeholders and project teams; risk identification, tracking, and management; project reporting; quality assurance; and, performance management. The Contractor shall provide contract-level, Task Order level, and task level project management to establish control, management, monitoring and notification mechanisms, ensuring that LIMS processes stay on track and important milestones are met.

The principal goal of the O&M (optional task) activities under this Task Order is to support an overall Laboratory Information Management System (LIMS) solution that is to be prototyped in two of the ORA laboratories. This includes all the associated activities listed in Section 2.2. This includes providing O&M to support the procurement of a LIMS, O&M in support of conducting the necessary activities to prove the LIMS in an ORA laboratory, and P&M in support of conducting the necessary activities to plan for and design the follow-on implementations for the rest of the FDA laboratories. The execution of the O&M task (optional task) under this Task Order will help build the base necessary to ensure the full and complete implementation of LIMS across all of the ORA laboratories.

2. Description of Work

2.1. Project management and Technical Coordination (Base Task)

(FFP)

2.1.1. Contract Level Program Management

The Contractor shall establish the program plans, structures, processes, schedules, reporting, communication channels, and quality control functions necessary to fully achieve the LIMS objectives. At a minimum, the Contractor shall:

1. Provide overall leadership, coordination, management, and reporting for all of the activities and tasks specified in all LIMS task orders;

2. Update, maintain and manage an overall LIMS Program Management Plan (PMP) that links the high-level activities of all LIMS task orders to overall contract objectives;

3. Develop, maintain and communicate a LIMS Integrated Master Schedule (IMS) to ensure that all task order deliverables and products are produced according to established schedules;

4. Develop, maintain and manage a LIMS Communication Plan and associated capability that takes into account a broad range of modes and requirements from ad hoc, informal check-ins and progress updates to weekly status reports to formal briefings to FDA Executive Management and key business unit stakeholders.

5. Establish control, monitoring and notification mechanisms to ensure that the task order activities and processes stay on track and important milestones are met.

2.1.2. Technical Coordination Activities

The Contractor shall provide program and technical coordination activities across awarded LIMS Task Orders and tasks. The Contractor shall provide project management support to monitor data quality to ensure adherence to FDA data standards for consistency, standardization, and compliance with the FDA Office of Information Management (OIM) Data and Information Standards and Technology (DIST) group’s guidelines.

Throughout the contract’s period of performance, the Contractor shall provide input regarding installation, operations, and maintenance to the FDA in managing the architecture and configuration of these four environments in relation to the LIMS. This includes, but is not limited to, the following activities:

1. Specification of capacity requirements, including the potential for a phased roll out.

2. Specification of server architecture to support data, application, and web tiers.

3. Providing documentation to support configuration and deployment such as White Oak Requirements Survey (WRS).

4. Supporting the schedule for implementing resources in the Development environment to be followed by the Test environment to be followed by the Pre-Production environment, to be followed by the Production environment.

5. Supporting the Information Technology Investment Management (ITIM) process including writing and submitting ITIM requests and tracking them from inception through completion.

6. 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. For the execution of work under this task order the contractor shall perform non-functional testing in the Test environment. The goal of this is to show an acceptable level of laboratory user performance and overall LIMS solution performance according to the Government-accepted levels of performance emanating from the Laboratory Assessment task order.

2.1.3. Task Order and Task Management

The Contractor, guided by this statement of work, and discussions with the Contracting Officer Technical Representative (COTR) and representatives shall prepare a Task Order Management Plan (TOMP) for each Task Order and a Task Management Plan (TMP) for each task describing the technical approach, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout task order execution. The TOMPs and TMPs shall contain a Work Breakdown Structure (WBS) and Project Schedule. TMPs may roll up into TOMPs.

The Contractor shall provide level of effort (LOE) estimates for each task or activity that takes into account all components of the work such as project management, and administrative support. The Contractor shall continually track the expenditures of the total available project hours which have not been allocated to a specific task or activity.

2.1.3.1. Create and Maintain Project Plans

The Contractor shall create and maintain Task Order and task project plans to reflect the specific scope, status, and deliverable schedules accurately. Individual task order and task activities shall be integrated into the overall LIMS PMP and IMS. Plans shall be provided in an editable form in a format that can be readily used on FDA systems (currently Microsoft Project 2003). The Contractor shall use the FDA tailored EPLC templates as agreed upon between the Government and the Contractor.

2.1.3.2. Maintain Task Mapping Matrix

The Contractor shall support the FDA COTR and Project Team by updating and maintaining a task mapping matrix submitted with the proposal. The task mapping matrix shall clearly identify the labor categories used to perform each task and how the proposed personnel will allocate their time across all tasks. It shall cover Key Personnel and all other personnel performing work under LIMS task orders. The task mapping matrix shall include the names of subcontractor personnel performing work under the contract. The names of subcontractor personnel shall be marked with an asterisk. If the Contractor has not identified a specific person to perform the function listed, the Contractor shall use an alias (e.g., Person A).

Post-award, the Contractor shall submit resumes of personnel they intend to add to the task mapping matrix to the COTR for review. The COTR will review the resumes to ensure that the personnel proposed have the appropriate skills sets and experience. No key personnel shall be added to or replaced in the task mapping matrix without COTR approval. Individuals must be added to the task mapping matrix prior to the commencement of the security clearance process described in the Order Administration Section of this Task Order.

Any proposed staff that are replaced by the start of the contract, or any staff that are replaced during the contract, shall be substituted with a staffing equivalent in terms of skills, experience, and any required certifications.

2.1.4. Meetings

2.1.4.1. Meeting Summaries and Agendas

The Contractor shall prepare meeting agendas and shall maintain and provide summaries of all meetings held with the FDA within the following timeframes: Agendas one business day In advance; summaries within 3 business days afterwards. Meeting summary shall include the following:

1. Summary description of all issues discussed,

2. Action items,

3. Personnel to whom the actions items are assigned,

4. List of meeting attendees, including name, organization, phone number, and e-mail address.

2.1.4.2. Ad hoc meetings

The Contractor shall participate in other meetings as necessary.

2.1.4.3. Weekly Status Meetings

The Contractor shall participate in weekly status meetings shall be held with the FDA Project Team to discuss general status of the project (including all executing Task Orders and tasks) and any issues as they occur, as well as to gain any FDA management updates and feedback. Review of project risks shall occur during these weekly status meetings.

2.1.4.4. In-Progress Review (IPR) Meetings

The Contractor shall participate in IPR meetings on a quarterly basis. The first IPR meeting shall be held within three months of contract award. Subsequent meetings shall be held every three months thereafter until the end of the period of performance of this task. The Contractor shall provide reports on activities that have occurred up to the date of the IPT and planned activities for the next three months. In addition, risks, issues, staffing, and costs to the Government will also be discussed in these meetings. These meetings shall be scheduled at least one month in advance and materials distributed at least three business days before the actual meeting.

2.1.4.5. FDA SME Requests

The Contractor shall provide requests for ORA business Subject Matter Expert (SME) engagement that gives ORA adequate time to garner ORA business SME involvement. There shall be at least a 1 (one) month lead time for requested ORA business SME time. For any meetings involving ORA business SMES, meeting agendas and materials will be provided at least two weeks ahead of the scheduled meetings.

2.1.5. Reporting

2.1.5.1. Monthly Reporting

The Contractor shall provide brief monthly technical progress reports to the COTR. These reports shall contain information on all of the work being performed by Contractor, whether in this task, Task Order, or other tasks and Task Orders. These reports shall be submitted during the following month on the Friday that is on the third or later business day of the month. For example, if May 31 falls on a Tuesday, then the report for May shall be due on Friday, June 3. If May 31 falls on a Wednesday, then the report for May shall be due on Friday, June 9. The reports shall include the following information:

1. Contract tasks that were to be performed in the prior month,

2. The progress made in completing these tasks,

3. Problems encountered or remaining from prior months,

4. Risks and issues (both backward- and forward-looking),

5. The expected approach to resolve problems from the prior month,

6. Task expected for the current month,

7. Budgeting implications or significant concerns to be addressed by the COTR.

2.1.5.2. Earned Value Management (EVM) Reporting

EVM must be handled according to certain provisions of American National Standards Institute / Electronic Industries Association (ANSI/EIA) 748. In addition, reporting must also adhere to requirements as designated in HHS OCIO Earned Value Management Processes and Procedures and HHS OCIO Policy for Information Technology Earned Value Management. Work performed by a Contractor must be managed according to these requirements, including necessary EVM System (EVMS) certification.

FDA personnel will be responsible for the EVM of the overall investment. The Contractor shall be responsible for the Earned Value (EV) data for their contracted portion of the investment.

EVM reporting is required using a standard Cost Performance Report (CPR). For Tiers 1 and 2, Contractors shall apply EVM for investments in order to produce standard OMB reports that provide EV data. Depending on contract value, the following EV reports will be required each reporting month (this is Tier 1):

The Contractor shall submit CPR 1-5 on the first business day of each month.

1. CPR – The CPR includes current period data as well as cumulative to date data, and is appropriate for high value, high risk contracts, and is delivered monthly. There are five formats for the CPR:

A. Format 1 provides earned values, scheduled values, and actual values at the WBS level.

B. Format 2 provides the same data but is grouped by functional type (e.g., Engineering, Systems Integration), rather than by the WBS.

C. Format 3 provides baseline information only, it tracks changes to the baseline throughout the contract’s period of performance.

D. Format 4 is a Manpower Loading Report. It excludes cost data and focuses on current and future staffing levels.

E. Format 5 is a Problem Analysis Reports/Variance Narratives. This format provides explanations for cost and schedule variances that have exceeded threshold. It provides a written explanation as to why the variance occurred, as well as written descriptions on how the Contractor plans to resolve the cause of the variance.

2. Cost Schedule Status Report (C/SSR) – The C/SSR is similar to the CPR in that it provides earned value, scheduled value, and actual cost value at the WBS level. However, the C/SSR only reports cumulative to date information and it is delivered monthly.

3. Contract Funds Status Report (CFSR) – The CFSR provides insight into the funding requirements of the program. It is reconciled to either the C/SSR or the CPR. The CFSR is a quarterly report, and will be required for all Contractors producing either a CPR or a C/SSR.

4. Contractors that provide the aforementioned reports will also be required to send the reports in electronic format (e.g., MS Excel, X12 format, XML, and Comma Separated Values (CSV)) to the

COTR. The COTR will then be responsible for forwarding this electronic format during the data call each month.

The EVM report is due by the first business day of the month. This will run one month behind. For example, a report due on May 1 will contain data through March 31. Program management (including project management activities) costs will be broken out as a separate reporting element in the CPR formats.

2.1.5.3. Integrated Baseline Review (IBR)

The Contractor shall perform an IBR in conjunction with the Government within three months of award.

This is a joint assessment of the Performance Measurement Baseline (PMB). A reference for this is provided here http://www.ndia.org/Advocacy/Resources/Documents/Content/NavigationMenu/Advocacy/Resources/PDF s30/program_managers_guide.pdf.

This will also include an assessment of the Contractor’s Earned Value Management System (EVMS), which is typically a collection of time tracking, invoicing, and other applications along with manual processes that ensure that an accurate picture of the progress of work is portrayed in EVM reporting.

2.1.6. Documentation

The Contractor shall deliver all required FDA tailored EPLC documentation. Please see the attached EPLC process documentation for detailed EPLC deliverables by phases. The existing project process agreement (PPA) is provided as an attachment. The contractor shall update it as necessary as progressive elaboration requires.

The contractor shall make appropriate updates to FDA tailored EPLC documentation as work progresses.

2.1.6.1. Create and Maintain FDA tailored EPLC Documentation

The Contractor shall ensure that all system documentation required by Department of Health and Human Services’ FDA tailored Enterprise Performance Life Cycle (EPLC) management process (see the attachment entitled EPLC Overview for Contracts) is complete and up-to-date. The existing PPA is provided as an attachment. The contractor shall update it as necessary and agreed upon by the Government as progressive elaboration requires.

This task is meant to capture all FDA tailored EPLC documentation requirements not captured with more specificity elsewhere in the Task Order.

The Contractor shall participate in the stage gate reviews of such artifacts and maintain them for the duration of the contract.

2.1.6.2. Support the Creation and Maintenance of Security Artifacts For security-related EPLC requirements, the contractor shall interface with and support both the FDA Security Architecture and Engineering Team and the Security Risk and Compliance Group. As part of the FDA tailored EPLC methodology, the Contractor shall support the creation and maintenance of security artifacts in accordance with FDA Security Policy for System Certification and Accreditation. These are listed in Section 5.1.

Security certification is the process of assessing the security controls (National Institute of Standards and Technology (NIST) 800-53 revision 3) in the targeted information system to determine whether they are implemented correctly, operating as intended, and are meeting the FDA system’s security requirements.

Security certification supports security accreditation by providing the FDA Designated Approval Authority with information needed to make credible, risk-based decisions about information systems operation.

http://www.ndia.org/Advocacy/Resources/Documents/Content/NavigationMenu/Advocacy/Resources/PDFs30/program_managers_guide.pdf http://www.ndia.org/Advocacy/Resources/Documents/Content/NavigationMenu/Advocacy/Resources/PDFs30/program_managers_guide.pdf

Security accreditation is concerned with risk acceptance and management. The Contractor shall assist the FDA Designated Approval Authority determine the risk to operations, assets, or individuals and the acceptability of the risk weighed against the FDA’s mission or business needs.

2.1.7. Configuration Management

The Contractor shall update and maintain a LIMS configuration management plan that is consistent with FDA tailored EPLC. The contractor shall perform the configuration management (CM) tasks in accordance with the Configuration Management Plan. The Contractor shall use the FDA’s instances of the CM software tools Jira and SubVersion. Jira will be used for managing change requests and SubVersion will be used for managing Configuration Items (CI).

2.1.8. Risk Management

The Contractor shall develop and maintain a risk management program that is consistent with the established FDA tailored EPLC standards and uses approved templates. The Contractor shall develop a risk management plan documenting how risk management will be implemented including all tools and processes.

2.1.9. Communications with Stakeholders

The Contractor shall support the FDA COTR and Project Team in their efforts to communicate project scope, issues, risks, and schedule—in addition to other topics, as required—to key business unit stakeholders. This shall include a quarterly newsletter to Stakeholders.

2.1.10. Laboratory Quality Assurance

The Quality Management System is a business program (not an IT system) that focuses on lab quality.

The Quality Management Information System (QMIS) 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.

2.2. Operations and Management (Optional)

This section details the work to be accomplished under the optional O&M activities under this Task Order.

2.2.1. Training and Support

The LIMS O& M Plan describes the technical approach, organizational resources and management to be employed to meet the cost, performance and schedule requirements throughout Task Order execution.

The Task Order Management Plan shall contain a Work Breakdown Structure and Project Schedule.

2.2.2. Training

The Contractor shall provide support for LIMS training. This includes activities in three areas:

2.2.2.1. Training Materials

The Contractor shall provide materials to support training such as draft user manuals. In addition, other inputs into training may be required. The Contractor shall deliver the documentation and reporting necessary to maintain an ORA Laboratory’s certification as it pertains to the LIMS.

2.2.2.2. Training the Trainer for the Pilot

The Contractor shall provide training for personnel from the ORA Division of Human Resource Development (DHRD). DHRD is responsible for the training for all ORA systems for FDA personnel including Lab staff. This may also necessitate training Lab engineers at Pilot location on key LIMS functions, e.g., configuration, operations, modification of software, user testing. The Contractor will be the Systems Administrator. The training, education and resource management (to include instruments management) to be provided by the LIMS Contractor should initially target laboratory functions such as, but not limited to:

A. Test Specimen/Sample and Request Receipt at Laboratory – the Contractor shall train ORA DHRD personnel to use the LIMS solution to receive samples

B. Test Preparation – the Contractor shall train ORA DHRD personnel to use the LIMS to do sample handling, batch preparation, etc.

C. Testing – the Contractor shall train ORA DHRD personnel to use the LIMS to perform testing, results recording and verification.

D. Test Scheduling – the Contractor shall train ORA DHRD personnel to use the LIMS to identify available qualified personnel counts by instrument, based on instrument availability schedule.

E. Proactive Specimen/Sample Collection – the Contractor shall train ORA DHRD personnel to use the LIMS to receive prescheduled specimens/samples, identify and schedule either single (one-time) requests, or recurring tests over some period of time and capture them in a test schedule.

F. Other functions and features required by the ORA Laboratories – the Contractor shall provide training to ORA Laboratory personnel on other capabilities relevant to their operations.

2.2.2.3. Environment and Live Support for the Pilot

The Contractor shall provide support to configure the environment used for the pilot to support training. In addition, DHRD may, from time to time, require that the Contractor provide personnel to directly support live training.

2.2.3. Support

The Contractor shall provide support for LIMS components. This includes activities in five areas:

2.2.3.1. Laboratory Instrumentation Computers

The Contractor shall provide support for instrumentation computers (instrument control) that reside in all the ORA laboratories and are related to the LIMS. The primary focus of this activity is to coordinate the hardware and software maintenance with the manufacturers of the instruments. This includes patches and software upgrades where these are not covered under contract with the instrument manufacturer.

Computers that are not used for instrument control will be the responsibility of DIO-FOB staff.

The Contractor shall provide troubleshooting support for problems related to instrumentation computers.

The Contractor shall coordinate with Lab ALM coordinators, DIO, or other contractors in resolving issues.

2.2.3.2. Laboratory Instrumentation Computers Maintenance Services The Contractor shall provide the following maintenance services:

1. Set up and assist with the day to day maintenance and update of laboratory instrumentation computers used to control experiments, acquire data, or analyze scientific laboratory data, including unpacking and any burn-in, installation, and/or hardware/software configuration where needed.

2. Set up and assist with day to day maintenance and update of the FDA’s instrumentation computers, including unpacking and any burn-in, installation, and/or hardware/software configuration where needed.

3. Instrumentation Computer Configuration Management includes modifying, maintaining, and deploying general scientific computing workstation "images" for each major operating system environment. Images will be based on standard FDA images as possible.

4. Support the installation and maintenance of antivirus software.

2.2.3.3. Security Maintenance of Laboratory Equipment

The Contractor shall remove instrument computers to be decommissioned to a designated area, update inventory database as required, and coordinate with appropriate agency personnel or contractors for degaussing and disposition of workstations per FDA security and property policies. The Contractor shall ensure that all pertinent data has been properly archived before decommissioning.

2.2.3.4. Laboratory Network Firewall Maintenance

Depending on the outcome of the DAR for how to address the security of the instrumentation PCs, the Contractor shall provide LIMS firewall expertise to the NOC and DIO staff who support the LIMS firewall hardware and/or software. This activity is applicable only to the pilot.

2.2.3.5. Help Desk

The Contractor shall maintain a helpdesk for laboratory instrumentation computer users. The Contractor shall use the FDA’s instance of HP Service Center for issue tracking. Calls will be made to the Employee Resource and Information Center (ERIC) Helpdesk and channeled to the Apps Desk, which is specifically for ORA in-house applications. Both the ERIC Helpdesk and the Apps Desk are staffed under a separate contract from this Contract.

The Contractor is responsible for providing to the Apps Desk documented steps to resolve the most common Tier 0 (self help), Tier 1 (triage, troubleshooting utilizing prior resolution recorded in knowledgebase), and Tier 2 (requires a higher level of technical expertise and familiarity with the applications) calls. The Apps Desk will channel all issues beyond Tier 2 to the Contractor. The Contractor is responsible for all Tier 3 activities, including updating information in HP Service Center, communicating with other Help Desks at FDA, communicating with equipment manufacturers, and direct contact with customers.

The Contractor shall provide troubleshooting support for infrastructure-related issues. Issues or problems may be identified by business customer, Division of Infrastructure Operations (DIO) or Contractors, and communicated to the Contractor via phone, email, or HP Service Desk ticket. The Contractor shall coordinate trouble-shooting efforts with the COTR(s) when infrastructure problems arise.

The Contractor shall provide support for defined Critical Customers. A Critical Customer is a person in the organization who has particular responsibility for some activity provided by a system. This is typically a member of upper management. The Contractor must handle issues from Critical Customers in a priority manner.

The Contractor shall provide regular Tier 3 help desk services during normal business hours (Core Hours). This is defined as 7:00 AM to 8:00 PM Eastern Time on regular business days. Weekends and Federal holidays are not regular business days. The Contractor shall provide a first contact to the customer within 30 minutes of receiving a Tier 3 issue.

The Contractor shall provide Tier 3 help desk support during Non-Core Hours. Non-Core Hours are any hours that are not Core Hours. This includes times between 8:00 PM and 7:00 AM Eastern Time and weekends and Federal Holidays. The Contractor shall provide a first contact to the customer within 30 minutes of receiving a Tier 3 issue.

The Contractor shall conform to FDA policies regarding ticket management (including new tickets, closure, reopening) and the severity and priority levels as defined by FDA (see Attachment, “Severity and Priority Code Descriptions”).

3. Deliverables

3.1. Project Management and Technical Coordination

The contractor shall submit the following deliverables for this task order. The contractor shall follow the review cycles of deliverables in section 9.8 of the IDIQ for Inspection ad Acceptance.

Deliverable Description Frequency/Due

Date (in calendar days)

Deliverable to

Task Order 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 order execution. The Task Order 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

Task Management Plan 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

Project Management Plan (PMP) (including all sub-plans)

Plan for managing the project. The FDA will provide a version of the current PMP as GFI. The Contractor shall deliver a PMP that is specific to how they will manage the project from the contract perspective.

Draft with proposal Final - 30 days after task award

COTR, IT PM,

Business PM

Integrated Master Schedule

The schedule of project activities. The schedule must include subject matter experts as a resource in addition to the FDA project team members and Contractor team members.

Draft with proposal Final - 30 days after task award

COTR, IT PM,

Task Mapping Matrix

Identify the labor categories used to perform each task and how the proposed personnel will allocate their time across all tasks.

Initial - At contract award Updates - As staffing changes

Deliverable Description Frequency/Due

Date (in calendar days)

Deliverable to

Meeting Summaries and Agendas

Summary description of all issues discussed

Action items Personnel to whom the actions items are assigned

List of meeting attendees, including name, organization, phone number, and e-mail address.

As needed

Weekly Status Reports

General status of the project and any issues as they occur, as well as to gain any FDA management updates and feedback. Review of project risks.

Weekly

Business PM, other Program Staff

Project Review Reports

Specific project activities and to address any potential problem areas that might arise, or have already arisen.

Project Review Report should also include quarterly Investment Board Reviews.

In accordance with (IAW) the FDA accepted project schedule

Business PM, other Program Staff (Investment Board)

EVM Reporting

Track actual costs incurred for all labor hour (DME) tasks Assign budget values to scheduled work elements using a work breakdown structure and critical path schedule, Credit budget values to the project as work elements are completed.

Within 30 days of task award and ongoing on a monthly basis

COTR, IT PM,

Business PM, ORA’s CPIC Coordinator

Integrated Baseline Review (IBR)

A review of the Contractor’s understanding of the scope, schedule, and cost. The Contractor shall deliver a report ahead of the IBR meeting.

Within 90 days of task award

COTR, IT PM,

EPLC documentation

See FDA tailored EPLC documentation requirements.

Government Furnished Information for EPLC deliverables by phases.

IAW the FDA accepted project schedule

Risk Management Plan IAW the requirements of the PMBOK and practice Standard for Project Risk Management

Within 30 days of task award.

Update on a Quarterly Basis

COTR, IT PM,

Business PM

Communications Plan Identifies stakeholders, defines rules of engagement

Within 30 days of task award.

Update on a Quarterly Basis

COTR, IT PM,

Business PM

Test Plans and Results This describes the plans and results for non-functional testing on the LIMS solution.

At least 10 days before the end of the task

3.2. Operations and Maintenance (Option)

Frequency/Due

Date (in calendar days)

Deliverable to

Task Management Plan 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

Training

Train the Trainer: The Contractor provides training for personnel from ORA’s DHRD, which is responsible for all ORA systems training for FDA personnel including Lab staff. This includes training Lab engineers at Lab Pilot location on key LIMS functions, e.g., configuration, operations, modification of software, user testing.

The Contractor will be the Systems Administrator. The training, education and resource management (to include instruments management) to be provided by the LIMS Contractor should target laboratory functions.

Preparation of materials and initiation of training within 30 days of task initiation

Environment and Live Support for the Pilot

Contractor shall: i) provide support to configure environment used for pilots to support training; ii) provide, as needed and in consultation with COTR, staff to support DHRD in its training.

Duration of entire Pilot training life cycle

COTR, IT PM,

Business PM

LIMS Components Support

Laboratory Instrumentation Computers: i) support for all LIMS related instrumentation computers (instrument control) residing in all ORA labs. Includes a) coordinating hardware and software maintenance with the instrument manufacturers; b) patches and software upgrades not covered by instrument manufacturer contract. ii) Troubleshooting support related to instrumentation computers. iii) Coordinating with DIO or other contractors resolving issues. iv) Provide SME staffing as necessary.

Lab Instrumentation Computers

During full task life cycle

Frequency/Due

Date (in calendar days)

Deliverable to

Daily Maintenance Services Provided: i) Set-up, maintenance, update of lab instrumentation computers used to control experiments, acquire data, or analyze scientific lab data. Includes full life cycle installation, start-up, and configuration as needed.

ii) Computer Instrumentation Configuration Management: modifying, maintaining, deploying general scientific computing workstation "images" for each major operating system environment. Images are based on standard FDA images.

Security Maintenance of Laboratory Equipment: i) Remove decommission-ed instrument computers; update inventory database; and, coordinate with appropriate agency personnel or contractors for degaussing and disposition of workstations per FDA security and property policies. ii) Ensure all pertinent data is properly archived before decommissioning.

Lab Network Firewall Maintenance:

During Pilot, provide LIMS firewall expertise to the NOC and DIO staff supporting LIMS firewall hardware and/or software.

Help Desk: i) maintain a helpdesk for laboratory instrumentation computer users; ii) Provide Apps Desk with documented steps to resolve the most common Tier 0, Tier 1 and Tier 2 calls.

iii) Coordinate trouble-shooting efforts with COTR(s); iv) Provide trouble-shooting support for business customers identified infrastructure-related issues. v) Provide timely support for defined Critical Customers.

vi) Provide regular Tier 3 help desk services during both normal business hours (core hours) and non-core hours

– within 30 minutes of receiving request. vii) Follow FDA policies re ticket management and prioritization.

4. Order Administration Information

4.1 Period of Performance:

Base Period (Program Management & Technical Coordination): 12 Months from time of task order award.

Option 1 (Operations & Maintenance): 12 Months from time of option exercise

4.2 Order Type: This task order is being issued as a Firm-Fixed-Price contract type per section 1 of the base contract and defined in FAR 16.6.

4.3 Place of Performance: Work is expected to be performed in a combination of Rockville, MD; Silver Spring, MD; and all FDA ORA lab facilities listed in section 7 “Place of Performance” of the contract.

4.4 Key Personnel: The labor category Program Manager is considered key under this task order.

4.5 Government Furnished Information/Government Furnished Equipment:

See solicitation attachments for Government Furnished Information

4.6 Inspection and Acceptance: The Government shall review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the Contracting Officer Technical Representative (COTR) Reporting Requirements/Deliverables shall be submitted to the COTR or government designee in accordance to the delivery schedule. The acceptance of deliverables and satisfactory work performance, required herein, shall be based upon the timeliness and accuracy of the deliverables.

Acceptance may be presumed unless, otherwise indicated in writing by the Contracting Officer or the duly authorized representative Contracting Officer Representative (COTR) within 10 days of receipt.

The Contractor shall implement necessary changes within 10 business days, or a mutually agreed upon period of time, from the day of change notification.

The Contracting Officer Technical Representative or the duly authorized representative shall perform inspection and acceptance of materials and services.

4.7 Contracting Officer’s Technical Representative (COTR): The Contracting Officer hereby appoints the following individual(s) as Contracting Officer’s Technical Representative(s) (COTR) for this contract/order:

Name: TBD

Address:

Phone Number:

E-mail:

It is emphasized that only the Contracting Officer has the authority to modify the terms of the contract, therefore, in no event will any understanding agreement, modification, change order, or other matter deviating from the terms of the basic contract between the Contractor and any other person be effective or binding on the Government. When/If, in the opinion of the Contractor, an effort outside the existing scope of the contract is requested, the Contractor shall promptly notify the Contracting Officer in writing. No action shall be taken by the Contractor unless the Contracting Officer approves in writing and/or issues a contract modification.

4.8 Section 508 Requirements: All electronic and information technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.accessboard.gov/sec508/508standards.htm - Part 1194.

4. Order Administration Information