15-223-SOL-00185_Atch_2_Task_Order_(Pilot)_SOW.pdf

15-223-SOL-00185 Atch 2 Task Order (Pilot) SOW

1. Background

The use of electronic approaches to data capture and annotation are making traditional methods of scientific recording less efficient every year. In addition, the existence of scientific workflow applications make paper based record keeping a process that is becoming increasingly removed from the practice of the research itself.

This task order pilots appropriate software application to provide an electronic laboratory notebook (ELN) as a replacement for paper based laboratory notebooks currently in use throughout the Center for Food Safety and Applied Nutrition (CFSAN). A number of commercial and open source systems exist.

2. Scope

The purpose of this task order is to acquire ELN software and licenses for a one-month pilot program that will take place during an estimated six-month period of performance allowing investigators time to use the software. The disciplines may include protocols performed in several of the following areas:

A. Analytical Chemistry Laboratories o Food additives o Allergens o Pesticides o Dietary supplements o Seafood toxins o Industrial chemicals

B. Bioanalytical Chemistry Laboratories o Elemental analysis o Natural toxins o Nutrients in food o Ingredients in dietary supplements o Ingredients of cosmetics

C. Microbiology Laboratories o Molecular detection, identification, and subtyping of pathogens o Foodborne parasites and viruses o Foodborne allergens and glutens o Immunobiology

D. Molecular Biology Laboratories o Molecular Genetics o Molecular Virology

E. Toxicology Laboratories o Reproductive o Neurotoxicology o Immunotoxicology o Molecular o High throughput methods in hepatotoxicity neurotoxicity renal toxicity cardiotoxicity dermal and nanoparticle toxicity

3. Uses Cases During the pilot, the Government will test the software against five use cases, as specified in Appendix 8 to the IDIQ, but included here for ease of reference, as follows:

• Use Case 1 Name: Design the Experiment

Actor: Principal investigator (PI)

Brief Description: The Principal investigator sets up an experiment that will be conducted by Lab

Technicians. The PI as well as the Lab Technicians will eventually need to collaborate on the experiment.

# Experiment Steps

1 Pull up a list of templates to design experiments and pick one. [Note: Try to include unstructured data and experimentation].

2 Enter Experiment Name “Prepare cell culture of a sample from site A”.

3 Create two workflows: Collect Sample (CS) and Grow Culture (GC). [See Use Case 3 for workflow steps].

4 Assign Collect Sample to Lab Technician 1 and Grow Culture to Lab Technician 2

5 Assign the experiment to a series of experiments (that are predefined before the demo). Then remove the experiment from the series.

6 If the ELN supports importing and exporting of workflows, then import the Collect Sample workflow. Change the workflow and export it.

• Use Case 2

Name: Administer Experiments

Actor: Principal investigator (PI)

Brief Description: The Principal investigator performs various administration roles. At the end of the experiment, the PI evaluates the results and requests that the experiment be redone.

1 Authorize (or start) the experiments after searching for other experiments and making sure that duplication does not exist.

2 During Use Case 3, reassign work from LT2 to LT3.

3 Before, during and after the experiments, look at dashboard that shows the various experiments, their status, and who they are assigned to. For the purpose of the demo, additional experiments and other data may be created.

4 Review the experiment from a PI perspective.

5 At the conclusion of the experiment, indicate that the experiment is not acceptable and should be repeated.

• Use Case 3

Name: Conduct Experiments (This use Case follows Use Case 1 and some parts of Use Case 2) Actors: Lab Technician 1 (LT1), Lab Technician 2 (LT2) and Lab Technician 3 (LT3)

Brief Description: Lab Technicians 1, 2, and 3 execute the workflows. The two workflows are dependent on each other and go side by side. CS and GC identify which steps the workflows belong to, and are described in Use Case 1.

# Actor Experiment Steps

CS1 LT1 Indicate that the sample is about to be collected.

GC1 LT2 Receive notification that 500 ml of “Broth A” should be prepared. Broth A contains ingredients Ing1, Ing2, and Ing3.

GC1 LT2 Look up inventory of Ing1. Weigh 50g, and add it to a beaker. Return the rest of the Ing1 back to storage. Note the amount that was weighed (example: 49.984 g)

Note: In this step, Inventory Management features are to be displayed or discussed.

Capability to map sample location in fridge/freezer; by lab room#, freezer #, drawer#, shelf#, rack# would be valuable. A grid or spreadsheet that displays the locations would be useful.

GC2 LT2 Weigh 1g of Ing2. In this step, the scale should be connected to the ELN and the reading obtained directly from the scale. For the demo, the step may be modified to use a connection to any small instrument/appliance such as a scale, pH meter, pipette…etc. If the connection is not possible, then a simulator may be used. At the very least, a short statement on how this step would be handled by the ELN should be made.

GC3 LT2 And Ing2 to the beaker (that contains Ing1).

GC4 LT2 Measure 50 ml of Ing3. Add it to the beaker. Record that 60 ml was added. Then correct the entry to 50. Add a comment or note that 60 was a typo.

GC5 LT2 Leave the beaker in the incubator at 37C.

CS2 LT1 Collect the sample from Site A and generate a unique sample ID (print bar code if possible) for it. This is Sample A.

CS2 LT1 Attach a picture of the sample collection site (any picture file may be attached in the demo).

CS3 LT1 Trigger notification to PI and LT2 that the sample has been collected.

GC6 LT2 Receive Sample from LT1.

GC7 LT2 Add 5 ml of sample to beaker and incubate it for 24h (or for a few seconds at the demo).

***See Use Case 3***. Work assignment has been changed from LT2 to LT3.

GC9 LT3 Check the pH of the solution in beaker. If the pH is less than 5, start workflow to “Add alkali”. If the pH is greater than 8, start workflow “Add Acid”. At the demo, show that either one of the two distinct workflows are executed, depending on the decision point.

GC10 LT3 Show or discuss support for math functions, stoichiometric calculations, mass, empirical and molecular formulas, chemical equations, percent yield, etc.

GC11 LT3 Scribble a note with finger or a pen (if the feature is available on the ELN)

GC12 LT3 Sign off that the work is complete. Demonstrate or discuss whether this can be done using PIV cards.

• Use Case 4 Name: Collaborate on Experiments

Actor: Principal investigator (PI), Lab Technician 1 (LT1), Lab Technician 2 (LT2) Brief Description: Actors collaborate on the experiment

# Actor Experiment Steps

1 LT1 See whether anybody else is working on or has recently worked with a sample from Site A.

2 LT1 Check the status of Broth A preparation (which is prepared in Use Case 3) at various stages of Use Case 3.

• Use Case 5 Name: Audit the experiment

Actor: Auditor

Brief Description: Review the experiment

1 Trace the various steps taken during the experiments. All steps with the start and end timestamps, comments, and corrections must be visible.

2 The chain of custody for Sample A (from Use case 3) must be visible.

4. Tasks & Deliverables:

4.1. Software Licenses

Contractor shall provide ELN software licenses with sufficient licenses for 16 users for one month.

4.2. Installation

Installation shall occur before the start of 1-month period. Vendor will be assisted during the initial installation of the software.

Contractor will be available for technical support during installation.

The proposed ELN solution shall be hosted at the FDA Scientific Data Center (SDC) and virtually available to scientists in remote locations. The FDA will not consider running the trial on a 100% cloud version of the Offeror's software.

4.3. Configuration

Contractor may conduct minor configurations to ensure software is fully usable and accessible to users during the pilot period. Prior to pilot FDA will configure to Host server prior to 1 month period.

If the Contractor does not have a FDA Enterprise accounts, and the ability to VPN into the Enterprise, configuration may be performed on-site.

4.4. Training

The contractor shall provide general online training materials and a user guide. The contractor shall provide an interactive online training session with users or onsite training at CFSAN Headquarters in College Park, MD.

Contractor shall include question and answer portion of training where users can ask questions about software and have immediate feedback. The contractor shall have training personnel available for direct and immediate contact with Government employees during business hours, either by telephone, in person or online through instant communication (such as chat).

4.5. Technical Support

The contractor shall provide remote technical support as defined in Section 5.4 of the IDIQ SOW.

4.6. Project Management

4.6.1. Kick off Meeting

The contractor Project Manager shall host a “kick-off meeting” via webinar with all stakeholders within five

(5) working days of the effective date of award. The purpose of the kickoff meeting is to introduce the contractor staff to the Government and discuss the contractor’s approach to meeting the requirements of this SOW.

4.6.2. Weekly Status Report

During the 1 Month pilot phase, the Contractor shall submit weekly status reports to the COR and hold weekly meetings with pertinent stakeholders to discuss findings. Status reports shall include:

• Status on the overall progress of the pilot

• Identification of foreseeable configuration or customization issues

• Change Requests: Who, what, where

• Issue log o Technical Compatibility issues o Ease of use issues o Configuration / customization issues o Compliance issues with functionality requirements identified in this SOW o Any other outstanding issues o Average time to respond to customer questions o Results of customer satisfaction surveys o Identified Risks o Next Steps Forward o Results of lessons learned

5. Deliverables

SOW

Section

Description Qty Due Date / Frequency Delivery POC

4.6.1 Kick-Off 1 EA 1-week after award COR

4.1 Pilot License

(Network)

1 EA Within 3-days of effective start date of the Pilot

COR & FDA SC

Computing team

4.4 Training

Materials and User Guide

1 EA Within 1-week of effective start date of Pilot

COR

4.4 Training 1 EA Within 1-week of effective

start date of Pilot

COR

4.6.2 Weekly status 4 EA Every 7 days from start of

the pilot

COR

6. Contract Type:

The Government anticipates this Task Order will be fixed price.

7. Period of Performance

Each software license will be piloted for approximately one month. In the event that the Government awards IDIQ contracts and task orders to multiple contractors, the software of each contractor will be piloted one at a time. Therefore, the period of performance for the pilot task order may be longer than one month, but the actual duration of pilot task will be one month and will occur at a time scheduled within the overall task order period of performance. More specifically, the Government expects the total period of performance to be approximately four to six months, while each specific software license will be piloted for approximately one month during the four to six month window.

8. Place of Performance:

CFSAN users are located throughout the United States.

The Contractor will provide all work offsite at the Contractor site. Onsite meetings, training and other events, if they occur, will be located at:

Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740

9. GFI/GFE:

The Government will provide badges, laptops, and network access as necessary to accomplish the task order.

The Government will provide access to FDA computers and access rights, including VPN, as appropriate.