Attachment A - LIMS Required and Value Added Features.docx

Attachment A - LIMS Required and Value added Features Solicitation: 15A00025R00000058 Attachment A – LIMS Required and Value added Features– Page 52 of 52 Table of Contents

1 Definitions

The calendar year is the period from January 1 to December 31. The federal government’s fiscal year is from October 1 to September 31. The four quarters are from October 1 to December 31, January 1 to March 31, April 1 to June 30, and July 1 to September 31.

Case number

The laboratory creates a unique identifier for each customer request. The unique identifier is based upon two parts. A case number, which is created whenever a request with a new customer project code (i.e., ATF investigation number) is accepted and a customer request number, which is a count of how many requests have been accepted for the same customer project code.

The Solution creates a new case number that is unique for each of the customer’s project code. Case numbers have a standard 7-character format consisting of three types of information. The first two digits represent the fiscal year when the customer request was accepted, followed by an ‘L’ indicating it is a laboratory case number. The last four digits represent the count of the new case numbers created during that fiscal year.

For example, case number 20L0123 represents the 123rd customer request for a new customer project code that was accepted in fiscal year 2020.

The third customer request for the same customer project code would have the identifier, 20L123-3.

Customer request status

When customers submit requests to the laboratory, the laboratory does not automatically start working on the request. A laboratory case manager has to review the request and agree that the laboratory will perform the requested work.

Received:

Before the manager agrees to perform the work, the status of the request is Received.

Accepted:

After the manager agrees to perform the work, the status of the request is Accepted.

Files and records that are stored in a secure electronic storage system, that have been marked as reviewed or approved in the system, are defined as having the electronic signature of the person that approved or reviewed the file or record. When files are downloaded from these systems, the downloaded files do not have electronic signatures unless the file has a certified digital signature.

Files that are not stored in a secure electronic storage system, are considered to have an electronic signature when they have certified digital signatures. PDF files must pass the “validate all signatures” function in Adobe Acrobat to be considered to have an electronic signature.

File format / File type A file format is a standard way that information is encoded for storage in a computer file. Examples of different file formats are XLSX for Microsoft Excel files and JPG for image files.

Laboratory Codes / Laboratory Abbreviations Each laboratory has a laboratory code that are used in case records, data mining, and management reports.

Laboratory

2 Workload process

The typical process for the ATF laboratories work product is outlined in Figure 1.

Figure 1. Laboratory workflow process

Most work for the laboratory starts with a customer request for assistance. The customer provides information, such as the ATF investigation number, the customer’s contact information, and the laboratory services they are requesting. If the request involves evidence, the request will also provide descriptions of the evidence and will include which services are being requested for each evidence exhibit. A Report of Investigation (ROI) is also required to be submitted with the customer’s request. This is currently a paper-based request process, and the ATF would like the new Solution to use a fully electronic customer request process.

Some laboratory work bypasses the customer request step and is initiated directly by laboratory staff. In these situations, laboratory staff perform the data input for the request and will identify the customer, who is often the ATF case agent.

After the laboratory receives the customer request, the details of the request are reviewed by a ‘laboratory case manager’ (LCM). The LCM can accept the request, reject the request, or work with the customer to modify the request so that the laboratory can accept the request. The status of the request before it is approved is ‘received’. The status of the request after it is approved is ‘accepted’. A notification is sent to the customer informing them that the request has been accepted by the laboratory and the laboratory case number.

After the request is accepted, it is assigned a unique laboratory case number. Customer requests often ask for more than one type of laboratory service and require multiple sections to work on the customer request. The section chief(s) for the requested laboratory services are notified that a new case assignment has been created for their section. The laboratory case manager (LCM) or section chief(s) will assign examinations to specific staff accordingly.

Case assignments are typically performed in a default order. Case assignments for the same customer request are often worked on simultaneously or there may be overlap between when one examination is completed and when the next examination starts.

The end product of each case assignment depends on the type of case assignment. The end product of case assignments can be an examination report, a record that an activity was completed, data sheets, or instrument data files.

2.1 Customer Request

Customer requests should be electronic, and in most situations, should be initiated by the customer. The process for creating a customer request should be optimized to reduce the amount of user input.

2.2 Laboratory Acceptance

An LCM should be able to review customer requests as soon as the customer creates the request. The customer requested priority should be predominately displayed for easy viewing.

When the LCM ‘accepts’ the customer request, the customer request is initiated in the Solution. The LCM can modify the case assignments that are associated with the requested services and can modify the default staff members assigned to each assignment.

2.3 Test Samples Receiving (Evidence Room)

Evidence is received at the laboratory by either shipping or hand delivery of the items beginning the laboratory chain of custody. Tracking information on how and when the items were received must be documented and a notification to the requestor that items were received must be made. The Solution should have a method to easily scan and upload any paperwork associated with the received evidence and easily associate the scanned documents with the customer request. The Solution should have a way to correlate the items received with information pre-populated from the laboratory acceptance process. The ability to make corrections to transmittal information such as investigation numbers is necessary; however, the ability to do this should be governed by the permissions. Items are placed in a designated location in a secure area until they are released to examiners. Multiple examiners in different disciplines may be working on the same case and the same or different items in the case simultaneously. Evidence transfers into and throughout the laboratory should allow for the use of barcoding.

Various test sample transfers are often necessary before the request is completed. Items are sometimes shipped between the laboratories. For instance, DNA evidence can be collected at the Atlanta lab and shipped to the Washington lab for analysis. The existing unique laboratory case number and exhibit numbers must remain the same even though work is done at a different location. Items are released to and received back from members of the organization outside of the laboratory system for external testing. Electronic transfer to these outside members should be available.

After all examinations are completed, evidence that was not consumed, destroyed or otherwise retained by the laboratory is returned to the customer via hand-delivery or shipping. The requestor may request that items be forwarded from the laboratory to other ATF groups outside of the laboratory system for further testing. Either of these actions completes the laboratory chain of custody. Tracking information on how and when the items were released must be documented. Evidence should be able to be resubmitted to the laboratory using the same previously-established exhibit numbers. The resubmitted evidence should reflect a new customer request number when ‘accepted’ by the LCM.

2.4 Case assignments

Case assignments should always be assigned to a specific laboratory section and discipline. Each case assignment can be linked to a specific examiner (lead examiner) or linking the assignment to a holding area for the laboratory section. The holding area should allow for the discipline’s section chief(s) to apply a unit priority level for additional prioritizing needs.

Each case assignment type should have a default examiner assignment for when the case first approved. Separate default examiner assignments should be defined for each laboratory and discipline in the laboratory.

2.5 Nomenclature (Case numbers, customer request number, exam codes) The laboratory assigns a unique, laboratory-generated identifier to each customer request. The unique identifier is based upon two parts. A case number, which is created whenever a request with a new customer project code (ATF investigation number) is accepted and a customer request number, which is a count of how many requests have been accepted for the same customer project code.

Case numbers will have a standard 7-character format consisting of three types of information. The first two digits represent the government fiscal year that the customer request was accepted, followed by a one-letter code ‘L’ indicating that it is a laboratory case number. The last four digits represent the count of the new case numbers created during that fiscal year.

For example, case number 20L0123 represents the 123rd customer request for a new customer project code that was accepted in fiscal year 2020 by ATF Laboratory services.

Sometimes the customer will make multiple requests for services for the same customer project code. The laboratory defines each unique request as a ‘customer request’ and the Solution automatically assigns each request a ‘customer request number’. Therefore, the first customer request for a customer project code is automatically assigned customer request number 1. When additional customer requests are received for the same customer project code, the next customer request number in the sequence is assigned to the customer request. For example, the third customer request for the same customer project code would have the identifier, 20L0123-3.

The case assignments related to the customer request each have a description and an ‘exam code’ as shown in Table 1. Each customer request can have different requested services and different people assigned to the requested services.

Table 1 shows examples of assignment types and exam codes. The Solution should allow the list of assignment types and exam codes to be defined by the ATF laboratory.

Table 1. Example assignment types and exam codes

In most situations, the laboratory will produce separate reports for each requested service for each customer request. For example, if there are two customer requests for the same case number, the laboratory will most often produce unique reports that will each be linked to their respective customer request and examination. In some situations, the laboratory may create reports that combine the reports from different customer requests. For example, if a case has two customer requests that each requested examinations for latent print and DNA. The laboratory may create a report for each latent print customer requests (2 latent print reports), and one report for both DNA customer requests.

2.6 Requested Features

The following list shows required features and optional ‘value added’ features. Required features are in bold and start with the words ‘Required Feature’. The numbers preceding each feature are the same as the numbers in the RFI that ATF published last year. If the paragraph numbers are not sequential, it is because the feature was removed after analyzing the RFI feedback. The values in parentheses and brackets are for ATF reference use.

General Information: Discipline, evidence source, receiving location/person, receiving date, submitting agency case number, submitting individual, submitting agency (field office), main offense, additional agency case number, number and type of packages, package description, notes, priority, linked customer requests.

Evidence Item Information: Items, quantity, description, submitting agency item number, external package label or barcode. [NIJ_5.1*] (RFI 2.6.2)

3 Record storage & management

3.1 File formats

The Solution should allow storage of file attachments of any file format and size. The storage Solution should not degrade the performance of the case management application. The Solution should allow for continued space allocation and storage management needs.

3.2 Record types

There are over one-hundred record types (not including images) commonly used in the ATF laboratories. More record types are added on a regular basis as more forensic disciplines transition to electronic records. The record types are: Analysis & Notes, Analyzed Latent Prints and Charts, Case Notes, Client Project Info, CODIS, Communications Log, Container, Court Details, Customer Feedback, Disclosure Example of record types include: DLI Data package, DNA CE Projects, DNA Quant Data, DNA Swab, DNA Worksheets, Electronic Records Log, Evidence Transmittal, Exhibit, FTIR Data, (P)GCMS, GeneMapper data, Genetic Analyzer, Lab Conditions, NGI Search Data, Photograph Inventory, Project Event, Real Time PCR, Reports and Documents, Review Form, SEM-EDS, Shipping, STRmix, Supplemental Info, Supplemental Videos, Transcripts, Video.

There are several record types that can include digital images that are commonly used in the ATF laboratories. These are: exam photograph, general picture, impression image, known latent print, latent print, microscope image, photograph inventory, scene photo, setup photos, supplemental photos, test photos, x-ray image.

3.3 View of pending and accepted customer requests

The Solution should have a dynamic user interface or configurable dashboard that displays customer requests and their acceptance status.

The dashboard should have a filterable table for factors such as which laboratory the requests are assigned to, whether to view all customer requests, or only the requests that have been accepted, rejected or still pending a decision. Furthermore, customizable fields for laboratory case number, a delimited string of case assignment codes, the request date, the customer’s name, and a case title, etc.

The assigned case assignments should be hyperlinked on the dashboard so the user can go directly to the case.

3.4 View of case assignments

The Solution should have dashboard that shows a table of case assignments.

The dashboard should have a filterable table for factors such as who is assigned, the completion status of the assignment, the type of assignment, the expedite status, etc.

The filterable table should display content that is customizable by the laboratory. For example, type of case assignment, completion status, received date, and location and availability of the evidence. Users should be able to search for case assignments and information based upon any of the case assignment metadata or customer request metadata regardless of the possession of the evidence. Users should also be able to view case assignments by various queries such as the date range.

Users should be able to go directly from this view to the ‘case assignment records’ view via hyperlinks.

3.5 Views of case assignment records - electronic case jacket view Users should be able to view case assignment records in two basic formats: case jacket format and exhibit records format.

The case jacket view should be customizable and separated into multiple categories defined by the laboratory. For example:

· Transmittal documentation

· Assignment details

· Communications and also see communications for all case assignments for the customer request

· Analysis, notes, reports, documents, and images per discipline

· Supplemental information

· Comprehensive Exhibit Listing

· Chain of custody

· Case activity history log These ‘case jacket categories’ should show a list of record types that are stored in each ‘case jacket category’.

3.6 Views of case assignment records - exhibit record view

The exhibit records view should show a list of test samples associated with the case assignment (exhibits and non-exhibits) and when the user selects the test samples, they should see a list of records associated with the test samples and segregated by record type.

In this view the user should be allowed to add additional records, where the user specifies the record type, the category for the record, and which test samples(s) the records might be linked to.

3.7 Viewing record details

When the user selects a specific record type in the case, they should see the details of the metadata associated with the records. If the record has a file format that has a preview, the view should either show the preview automatically or have a function to allow the user to view the file.

Users should be allowed to add additional records. Any table/fields should have functionality to copy, paste, and fill-down so that the user does not have to manually re-enter values.

The laboratory should be able to define types of records that will be uploaded to Solution and the different types of records should be able to have custom metadata fields.

The Solution should provide a permission/role-based system to assist in controlling access to the case jackets or parts therein.

3.8 Communications

The users should be able to import communications records stored in files, import emails directly from Outlook, and users should be able to enter notes manually about a communication.

Users should be able to view emails associated with the selected case assignment in Outlook MSG format without the user having to perform any type of conversion on the file. Users should also be able to see communications associated with all assignments associated with the customer request.

3.9 QC, Reagents, Calibration Standards

The Solution should have the ability to retain information pertaining to quality control, laboratory reagents, and calibration standards.

3.10 Instrument records

The Solution should have the ability to import Instrument records. The imported files should include all files required to run an analysis of the data including any audit files. When the instrument or analysis creates multiple files, the Solution shall import and download all the files as one package.

The instruments at the ATF laboratories are located on an isolated network that cannot reach the ATF network or the internet. There is one server that is configured to act as a gateway between the ATF network and the isolated instrument network. This server has share drives and a Microsoft SQL server database. Software can be loaded on this server to perform data imports from the instruments to the Solution.

ATF would prefer that the Solution be able to upload instrument files from the instruments on the isolated network. If this is not possible, ATF will accept a Solution where the instrument files can be imported from the gateway server’s share drive and the existing SQL server database.

3.11 File Authentication

Some files that are uploaded require authentication using a hash code or similar authentication. The hash should be calculated from the original file prior to uploading the file. The Solution should have functionality to be able to compare files by their hash and verify that a file is the same as the uploaded file.

The Solution should provide an audit trail for the records.

3.12 File Previews

The Solution should be able to efficiently (minimal clicks, hoovering feature) show previews or thumbnails of uploaded files or photos that are in one of the common formats (MS Office, jpg, tiff, PDF, email msg, txt, etc.). When uploaded files are contained in a compressed (zipped) file the Solution should be able to show previews of the zipped files.

The Solution should allow multiple files/photos to be open simultaneously.

3.13 File verification

As part of the review process, a user must be able to efficiently verify that the correct files were uploaded. For example, if the case record, contains 50 PDFs of shipping documents, the reviewer should be able to quickly preview of each file and record in the Solution that the file was verified. The file verification is a cursory review. It is not a detailed examination.

The Solution should have the ability to guide the review process to ensure necessary documents have been reviewed.

3.14 File Downloading

The Solution should have robust functionality for downloading case records and uploaded files.

3.15 File Naming Conventions

When files are downloaded from the Solution, the Solution should be able to have customized naming formats for each record type. The Solution should also be able to download the files into folders with predefined naming formats for each record type.

The Solution should be able to download files with their original names and with their original folder structure. This is required so that analysis software can perform subsequent analysis on uploaded files.

The Solution should allow users to select multiple files to generate a custom case record report. The Solution should have a dynamic event log that records which files were downloaded.

When folders/files are uploaded, the Solution should maintain a record of the original file name.

3.16 Requested Features

The following list shows required features and optional ‘value added’ features. Required features are in bold and start with the words ‘Required Feature’. The numbers preceding each feature are the same as the numbers in the RFI that ATF published last year. If the paragraph numbers are not sequential, it is because the feature was removed after analyzing the RFI feedback. The values in parentheses and brackets are for ATF reference use.

•a date and time stamp of creation, (2) The user has the option when entering records to denote: (3) the type of record (Lab defined list, section 3.2) (4) have an area for free text [LET_147] (RFI 3.16.7)