Attachment 42-Demonstration Instructions.pdf

Attachment 42 Instructions for the Demonstrations

These virtual demos will be conducted by vendors that remain in the competitive range. FDA will notify these vendors once the selection is made.

1. Introduction

1.1. Virtual Demonstration Description

For each of the scenarios listed below, the Offeror shall assume a lab environment that is equivalent to each of the Pilot labs described in the Pilot Task Order 1. The equipment and environment for the hypothetical labs used in the scenarios are equivalent to the equipment and requirements referenced in each Lab Pilot environment. For the scenarios that involve chemistry, the Offeror shall assume that the environment is composed of chemistry equipment that is equivalent in number and complexity to the microbiology environment.

During the virtual presentation, an Offeror will present with whatever equipment it brings. Any interfaces described in the scenarios will be simulated by the Offeror using pre-generated data provided by the Offeror. The presentation will take place in a standard conference room. The Offeror shall provide computers/laptops, projectors, screens, and other required equipment. No material handouts will be allowed. There will be no Internet access in the conference room. The Offeror may not bring any recording devices, but the Government may record the presentations.

For the purposes of this document, the term “simulation” is understood to mean a process whereby functionality is demonstrated only using the allowed equipment for this demonstration and the Offeror’s proposed software solution. For the purposes of this document, the referenced “external interfaces” are outside the scope of what will be evaluated.

The demonstration may last a maximum of three (3) hours. In addition, twenty (20) minutes will be allowed for setup and an additional twenty (20) minutes for breakdown.

Offerors shall demonstrate according to the provided scenarios only. If a demonstration shows all of the provided scenarios before the allotted time is completed, then the demonstration shall be concluded.

For modeling the laboratories and performing the demonstration, Offerors may make use of the FDA ORA Laboratory Manual of Quality Policies (available at http://www.fda.gov/ScienceResearch/FieldScience/ucm171208.htm) and The Investigations Operations Manual (available at http://www.fda.gov/ICECI/Inspections/IOM/default.htm).

For Scenarios 3 and 4, Offerors shall make reference to the Form FDA 525 is on page 151 of 2011 IOM (Ref: Section 4.5.5.1 - Sample Package Identification and FDA 525) and Form FDA 484 is on page 108 of IOM 2011 (Ref: Section 4.1.1.3 - Receipt for Samples).

During the presentation, the Government will not pose questions. Any questions the Government may have will be forwarded in writing to the Offeror after the presentation as discussion questions.

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2. Functional Scenarios

2.1. LIMS setup

Scenario 1 – LIMS manages user accounts, sample types, and laboratory administrative processes

1. LIMS helps define user profiles, modify privileges, and audit each user account:

Lab supervisor, QC/QA reviewer, lab Analyst, and a sample custodian.

2. LIMS supports sample types:

a. Regulatory sample

b. Non-regulatory sample

3. Create and modify a sample test process flow to manage a sample with the following functions: receive sample, categorize sample, accession sample, assign sample, track sample, store sample, print reports, timeframes monitoring, employee workload, and real time sample status.

2.2. LIMS interface with lab instruments

Scenario 2 – LIMS automates interface with laboratory instrument.

1. One-time data capture from Chemistry instrument - Integration of the LIMS with an HPLC-MS instrument

2. This step will simulate one analysis sequence.

3. LIMS system performs data calculations.

4. LIMS system flags hold time expirations.

5. Users are notified when testing conditions exceed limits.

6. LIMS external data integration into sample records.

2.3. Sample workflow example

Scenario 3 – LIMS manages the submission of a single item case to an ORA laboratory by an external system. The servicing laboratory depends on the Program Assignment Code (PAC) and Problem Area Flag (PAF) associated with the sample. These are unique alphanumeric codes used within FDA to define sample and analysis types (e.g. Microbiology, Chemistry, etc.). The PAC identifies the Compliance program being supported and the PAF identifies the particular analytical operation being requested. Sample PAC and PAF codes are available in the IOM (http://www.fda.gov/ICECI/Inspections/IOM/default.htm).

The single item case includes:

Receiving the work request from an external system in the

LIMS

1. The LIMS sample number (assignment number) should be inherited from an external system. If not, the LIMS sample number must be associated with the external sample number at all steps, including sub-samples.

2. Check that the PAC of the work request corresponds to the lab services.

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3. Check the PAF of the work request. PAF specifies the appropriate FDA format for documenting the analysis results.

4. Date/Time Received: mm/dd/yyyy

5. Check submitting Officer/Agency

6. Check sample package label

7. Check box on LIMS screen that sample has been submitted in sealed package.

8. Mark work package (work request and physical sample) as received.

9. Demonstrate proof of chain of custody features throughout the process.

A Receipt for Samples (Form FDA 484) is retrieved from an external system or is re-generated and given to the submitting requester.

Based on FDA 484 (http://www.fda.gov/downloads/ICECI/Inspections/IOM/ucm127401.pdf ), this form must include the following information:

Laboratory name Laboratory Control Number (LCN) LIMS-generated Date/time received Submitting agency Submitting agency sample number Submitting requester name Assignment due date Laboratory sections (Food Chemistry, Microbiology, Drug

Chemistry, etc.)

Printable barcodes A printable bar code label for the work request for laboratory services is shown on a print preview screen. The label information includes, at minimum, the following information:

LCN bar code Sample number (assignment number) The laboratory name

PAC

PAF

Assign test to lab analyst

Verify available lab resources (sample load, analyst availability).

Verify qualifications and training of the lab analysts in the laboratory (simulated).

Verify equipment availability for conducting the analyses (simulate).

Assign work to a lab analyst.

Assignment includes procedures/methods to be used, available instruments that can be used to perform the analyses, and the due date for completion of the analyses.

Notify analyst via email (simulate).

Dispose of sample When Compliance Officer marks the sample as approved for disposition, the LIMS receives the disposition assignment information from an external system (simulated).

Analyst disposes of the sample and updates LIMS as such.

LIMS notifies an external system of successful disposition (simulated).

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2.4. Auditing and tracking lab activities using the LIMS

Scenario 4 – LIMS ability to audit and track information related to lab activities

Audit sample management and sample tracking

1. Peer review is conducted through the LIMS. Notify analyst that analytical report is ready for review.

2. Supervisor approves a sample analysis report through the LIMS.

Notify Supervisor that analytical report is ready for review.

3. Demonstrate how corrections can be made by a supervisor and by a peer reviewer. Include the approval process and electronic signatures.

4. Demonstrate locating and viewing the sample analysis report through the LIMS.

5. Demonstrate the routing or automatic email notification of a priority assignment to the LIMS.

6. Demonstrate the secure generation of multiple electronic worksheets via MS-Word for Windows to maintain audit trail functionality.

7. Demonstrate the secure (encryption) storage of electronic signatures with an evidence receiving transaction.

Audit instruments

Demonstrate the use of a LIMS audit log book to ensure that proper maintenance and calibration schedules are followed (e.g., when an instrument is overdue for preventive maintenance).

Audit inventory levels Demonstrate the tracking of instrument inventory levels (analytical equipment, metrology devices, or peripheral equipment).

Demonstrate the capability to audit inventory supply levels of reagents, and managed substances (e.g., precious metals, alcohol, and other controlled substances).

Audit trail of data entries

Demonstrate the tracking of any changes to the sample record by any user in an audit trail.

Pre-audit of sample analysis

Demonstrate a pre-audit based on analytical test algorithms on calculations and analytical results for “worksheet checks/reviews.”

2.5. Multiple workflows within one LIMS instance

Scenario 5 – LIMS enables multiple workflows. A single sample of a food product may be split into multiple split samples: one for microbiological analysis, and a second for filth analysis. When a sample must be split to be used for multiple analyses, the order of the analyses must be taken into consideration. The split must be performed under sterile conditions; therefore, the LIMS should first specify in the workflow that the sample be first checked by Microbiology for split, and then the split sample would be sent to the Filth lab for analysis.

Modify workflow to include split samples

Demonstrate that LIMS can modify workflow to incorporate inter/intra lab chain of custody.

Demonstrate that samples received with a unique sample identifier can be split into multiple portions, can be identified and tracked, and can be related back to the original received unique sample identifier.

Demonstrate the “intra-lab” (within one laboratory) sample portion

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Demonstrate the capability to initiate a transfer and track a sample portion among multiple laboratories using a sample tracking process.

Analysis documentation

Demonstrate how an analyst would populate an approved analytical worksheet (Form 431— http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Fo rms/UCM072762.pdf) to document the procedure followed and the results received.

Demonstrate that every time the sample is split, the LIMS generates a new worksheet and a notification is sent to an external system.

Ad hoc Worksheets Demonstrate how a worksheet can be generated for special analysis for high priority or emergency response methods including allowing data capture into the sample record.

2.6. Media/Reagents/Sterile Items Preparation Component

Scenario 6 – The LIMS allows the entry of media, reagents, and sterile items used for single analysis and batched analysis (multiple samples) with QC control by interfacing with a Media/Reagents/Sterile Items Preparation Component.

Media/Reagents/Sterile Items Preparation Component

Demonstrate that the LIMS allows for the tracking of all data relevant to the preparation of the media, reagents, and sterile items used for analysis.

Demonstrate that the LIMS data include formulation, preparation conditions (autoclaving, filter sterilized, etc.), and QC control.

Batching of multiple samples to media/reagents/sterile items.

Demonstrate that LIMS allows the data entry for all items (media, reagents, sterile items) used for multiple samples (batching of samples relating to the items used).

LIMS interfacing with Media/Reagents/Sterile Items Prep Component

Demonstrate that LIMS can cross reference with the media preparation component to provide QC control (expired media usage, correct media selected for analysis, etc.).

3. Demonstration Evaluation Criteria

The Government will be evaluating the following factors.

3.1. Factor 1: Off-the-shelf capability and configurability of the proposed solution

The demonstration shall reflect the system originally proposed by the Offeror in its Technical Proposal.

This factor will be evaluated according to the following elements (in no particular

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• How well can the proposed solution be implemented right out of the box to support FDA processes? How much configuration will be required?

• Are Business Logic and processes built into the proposed solution?

3.2. Factor 2: Scientific data management within the

proposed solution

The demonstration shall show the capabilities of the proposed solution for dealing with scientific data.

This factor will be evaluated according to the following elements (in no particular order of precedence):

• How does the proposed solution manage the scientific data that comes off the instrument?

• How are the data stored?

• Do the data need to be reformatted or processed prior to storage?

• Does the proposed solution perform or allow data mining?

• Is there a delay between collection and queryability (e.g., if the data are cached and then dumped)? Or are these functions performed through middleware?

3.3. Factor 3: Adaptability and flexibility of the proposed

solution

The demonstration shall show the adaptability and flexibility of the proposed solution to handle a complex and dynamic business environment.

This factor will be evaluated according to the following elements (in no particular order of precedence):

• How configurable are the workflows for the administrator?

• How modifiable are the workflows for the administrator?

• How well does the proposed solution handle sample splitting?

• How well does the proposed solution satisfy ad hoc demands, such as when a report is needed on a sample before its analysis is complete?

• How well does the proposed solution allow a super-user to override system flags?

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3.4. Factor 4: User-friendliness

The demonstration shall show the graphical user interface of the proposed solution, including whether it inhibits the workflow or requires many steps to perform most functions.

This factor will be evaluated according to the following elements (in no particular order of precedence):

• How well does it guide the average user through the workflow?

• How many clicks are required for most actions?

• How many iterative steps are required for most actions?