APPENDIX A - SUMMARY OF REQUIREMENTS

CATEGORY REQUIREMENT LIMS DOS

SECTION

CODE YES, YES/Clarify

Alternate, NO

COMMENTS

Project Description

2 The new LIMS shall provide the functionality and automation necessary to obtain complete laboratory visibility in an environment that complies with Good Automated Laboratory Practices (GALP) and 2001 or later National Environmental Laboratory Accreditation Conference (NELAC) standards.

1 M

Network Server

2 The delivered LIMS shall include managed file and print services.

2.1 M

Database

2 The database application is Oracle version 8.1.7 or higher hosted on Sun servers under the Solaris version 8.0 or higher operating system.

2.3 M

Contract Performance

3 The LIMS should be available for full production use by June 2003.

3.1 HD

General System Requirements

1,2 The primary design of the delivered LIMS should be thin client (browser based) utilizing Oracles 9iAS as the internet application server.

4.1 HD

1,2 The system shall allow a minimum of 25 simultaneous users without degradation of system performance.

4.1 M

1,2 The delivered LIMS should be pre-configured with an auto logoff capability that logs a user off the system after a period of inactivity.

4.1 HD

1,2 The delivered LIMS shall support users external to the IL EPA location via a Wide-Area Network (WAN), dial-in, or Internet access with appropriate security, subject to the limitations of the available bandwidth.

4.1 M

2 All network applications must support Transmission Control Protocol/Internet Protocol (TCP/IP) Standards.

4.1 M

2 All client components of the delivered LIMS shall be fully 32-bit compatible with Microsoft Windows NT 4.0/2000 or higher.

4.1 M

1,2 The delivered LIMS shall be based on industry-standard, commercially available components and tools such as visual basic and HTML/ASP editors.

4.1 M

Clock

1 The delivered LIMS must utilize a true 24-hour clock. 4.1.1 M System Security

1 The delivered LIMS shall provide security to protect the integrity of the data.

4.2 M

2 The security measures shall be compatible with Novell networking, Sun Solaris, Oracle, Internet Explorer, and Windows NT or 2000.

4.2 M

Central Database Security

1 The delivered LIMS shall provide configurable security for the central database. Any method of accessing the central database, whether through the LIMS application or external programs, shall require a login identifier and password.

4.2.1 M

1 Security shall be capable of providing read-only, limited editing, and full access to the database and be configurable as to types of access granted to all objects within the central database.

4.2.1 M

LIMS Application Security

1 The delivered LIMS application shall provide configurable security for all users of the application, whether internal to IL EPA or external.

4.2.2 M

1 Each user shall gain access to the application through the use of a login and password. Based upon the user's information, the application shall control which menus, screens, and functions within screens are available to that specific user at a specific location.

4.2.2 M

1 User security shall be configurable by IL EPA LIMS administrative personnel.

4.2.2 M

1 The delivered LIMS should have the ability to access network resources utilizing the Entrust PKI technology.

4.2.2 HD

Server Resources Security

2 The delivered LIMS shall include configurable security for access to network resources such as printers, directories, and files.

4.2.3 M

2 The delivered LIMS should use the existing Novell and Oracle security functions.

4.2.3 HD

External Application Interaction

1 The System shall be Open Database Connectivity (ODBC) compliant.

4.3 M

E-Mail

1,2 The delivered LIMS shall have the ability to automatically send reports and other information to authorized LIMS users and laboratory clients via the IL EPA e-mail system.

4.3.1 M

Electronic Data Deliverables

1 The delivered LIMS should be pre-configured with the capability to create EDD(s) and flag the selected samples as transferred.

4.4 D

1,2 The delivered LIMS should be pre-configured to accept EDDs from program databases and use the information to update the LIMS database.

4.4 HD

2 The delivered LIMS shall also be pre-configured with all the fields needed to create and select EDDs that will directly feed into the other programs listed in the previous paragraph and contained in Appendix C.

4.4 M

2 The delivered LIMS vendor must perform the analysis, design, development and implementation of the EDD or EDDs to feed the programmatic systems.

4.4 M

1,2 The delivered LIMS should be pre-configured to create and receive EDDS for instrumentation, hand held Personal Digital Assistant (PDA's), other programs and other devices.

4.4 HD

1,2 The EDDs shall not be written in a proprietary language. 4.4 M Use of Bar Codes

1 The delivered LIMS should be fully compatible with and pre-configured for use of bar code reader devices for entry of selected information such as sample identification and laboratory standards for analysis.

4.5 HD

1 The delivered LIMS should generate bar code labels of various sizes, with mixed text and bar codes, for use in sample and batch identification and any other areas where bar code labels will enhance user productivity.

4.5 HD

LIMS Documentation

3 The vendor shall include electronic and printed documentation for the delivered LIMS. The documentation shall include a design specification detailing LIMS functionality as well as the design of the database including work/data flow diagrams and database entity relationship diagrams.

4.6 M

System Administration

3 The proposer should supply all tools and 3rd party software necessary for proper administration of the System, the user interface, and any auxiliary programs integrated into the System.

4.7 HD

1,2 The delivered LIMS should not rely on proprietary technology or components.

4.7 HD

LIMS Warranty and Support

5 The vendor shall be capable of providing: (1) On-Site Support, (2) Telephone Support (Indicate days and hours of availability), (3) File Transfer Protocol (FTP) Support, (4) Remote access support.

4.8.1 M

IL EPA Operations

2 The delivered LIMS shall support IL EPA laboratory business processes and be a central repository for all laboratory data collected from all of the data sources identified throughout this document.

5 M

Sample Creation and Login - Required in New LIMS

1 The delivered LIMS should allow for automatic and manual prescheduling of samples and should allow users who create samples the ability to designate which bottles are needed for the sampling.

5.1.2 HD

1 Lists of routine sampling points shall be stored in the LIMS, which shall allow users the flexibility to add, delete, and mix the listed sample locations to accommodate day-to-day sampling activities.

5.1.2 M

1 The delivered LIMS shall designate certain samples as "Split" samples based on program criteria. It shall also allow login personnel to edit this feature with a full audit trail.

5.1.2 M

1 The delivered LIMS should allow bottle preparation personnel to generate and print a list of samples that need to have bottles prepared for sampling. It should allow laboratory personnel and other IL EPA personnel to filter through the list and select which samples to generate labels and COC for.

5.1.2 HD

1 The delivered LIMS should be able to automatically create the required Field QC samples as defined by and based on a frequency specified by the IL EPA.

5.1.2 HD

1 The delivered LIMS should generate a partially completed COC and bar coded sample tags to be sent out with the bottles.

5.1.2 D

1 The delivered LIMS should be capable of uploading electronic data from probes, handhelds, etc. and later associate the data to the correct sample(s).

5.1.2 D

1 The delivered LIMS shall have the ability to specify that no date or time of sample collection was provided.

5.1.2 M

1 COC information that the delivered LIMS shall manage includes but is not limited to the following: Site location, Sample point identifications, Funding Code, Facility Number, contact person and phone number, sample type (grab/composite), sample matrix, container type, date/time sampled, collected by, requested turnaround, analyses to be performed, comments, and custody transfer (relinquished by/received by). The delivered LIMS shall be pre-configured to accept this information.

5.1.2 M

1 The delivered LIMS should be configured to allow login personnel to create a COC and labels when samples are received without any.

5.1.2 HD

1 The delivered LIMS shall allow IL EPA personnel the ability to assign a priority to a sample when it is received. Additionally, the delivered LIMS shall allow users to change the priority of a sample at any stage of the process.

5.1.2 M

1 If the sample is already in a batch when the priority change occurs, the LIMS should change the font color or identify in some manner, the sample and the batch containing the sample.

5.1.2 D

1 The delivered LIMS should be able to automatically notify designated IL EPA Laboratory and Bureau personnel when a sample is received out of holding time or exceeds a limit for Chlorine, pH, and Temperature.

5.1.2 HD

1 The delivered LIMS shall allow IL EPA personnel to cancel a test scheduled for a sample without canceling the whole sample with full audit trail.

5.1.2 M

1 The delivered LIMS shall allow IL EPA personnel to add tests at a later date with full audit trail.

5.1.2 M

1 The delivered LIMS shall also allow for canceling of an entire sample with full audit trail.

5.1.2 M

1 The delivered LIMS should maintain a distinct, sequential sample numbering system that would permit distinction between the laboratories.

5.1.2 HD

1 The LIMS shall provide the Springfield and Champaign laboratories with a means of distinguishing which samples are theirs.

5.1.2 M

1 Each sample shall be assigned a unique number. The delivered LIMS shall generate sample identifiers for all fractions received.

5.1.2 M

1,2 The delivered LIMS should provide a means of filtering analyses specific to the laboratory location and sample matrix. The LIMS should provide the same filtering capabilities throughout all functions of the product.

5.1.2 HD

1 The delivered LIMS shall allow login personnel to flag a sample, or group of samples, if any information on the COC is unclear or causes conflict with normal processing procedures. The LIMS shall notify the analyst of any irregularity, such as insufficient or improperly preserved samples.

5.1.2 M

1 The delivered LIMS should allow login personnel to flag a sample and add comments that follow the sample throughout all statuses, if the sample is thought to be hazardous or highly contaminated. Samples that are flagged for this reason should be presented noticeably differently from other non-hazardous samples.

5.1.2 D

1 The delivered LIMS should have a place at the test or analysis level to define and enter configurable limits for the conditional criteria.

5.1.2 HD

1 If the defined criteria is not met, the delivered LIMS should flag only the analysis whose condition limits have not been met for the sample, bring it to the attention of the IL EPA personnel, allow the personnel to override the flag, and if overridden, require the personnel to enter a comment as to the cause of the override.

5.1.2 HD

1 The delivered LIMS shall have a place for "comments" that are communicated throughout the System to authorized analysts, management and end-users.

5.1.2 M

1 The delivered LIMS should also allow for multiple levels of comments.

5.1.2 HD

1 All comments fields shall allow for pre-configured editable comments as well as Free-text entry.

5.1.2 M

1 The delivered LIMS shall have the capability of maintaining an internal Chain of Custody for samples that require it.

5.1.2 M

1 The delivered LIMS should allow/require login personnel to designate where a sample is being stored, as part of the login process.

5.1.2 D

Workload Management - Required in New LIMS

1 The delivered LIMS shall produce work-lists and management reports (both on-screen and printable).

5.2.2 M

1 The delivered LIMS should provide information concerning the samples in the LIMS in order for laboratory personnel to schedule work.

5.2.2 HD

1 The delivered LIMS shall be pre-configured to query the database by test code, group of test codes, or by analytical section.

5.2.2 M

1 The analyst should be able to prioritize the workload by parameters such as remaining hold time, special turnaround requests, priority, or by date received with the delivered LIMS.

5.2.2 HD

1 The analysts should be able to select samples to be processed and generate QC batch worksheets.

5.2.2 HD

1 The LIMS should provide the QC batch work-lists on-screen, in printable form, or as an EDD to be able to be uploaded to laboratory instrumentation through third party interface as provided by IL EPA.

5.2.2 D

1 The delivered LIMS should noticeably distinguish samples that have been flagged as potentially hazardous.

5.2.2 D

1 The delivered LIMS should keep track of prep and analysis hold times in units of hours and days and should distinguish between the two hold times. The overall hold time should be the sum of the prep and analysis hold times.

5.2.2 HD

1 The delivered LIMS should generate lists of all pending work according to the remaining hold time, age of sample, specific site, priority, or turnaround requested, and allow the analyst and laboratory management to differentiate among the five.

5.2.2 HD

1 The on-screen display should include a user-controlled filter to help define the format of the criteria of the listed samples.

5.2.2 HD

1 Flags for calculated (remaining hours and/or days) short hold times should be available on all work-lists and the delivered LIMS should actively/automatically notify designated personnel when a specific threshold is reached.

5.2.2 HD

1 The delivered LIMS shall assign sample and analysis status values when samples are received, logged and processed by the lab including but not limited to the following: Received, Prepared, Analyzed, QC Review, All Tests Complete, Reported, Transmitted (Bureaus), Sample depleted or disposed and the level of QC Review.

5.2.2 M

1 The delivered LIMS shall allow the analysts the ability to change the status of the sample.

5.2.2 M

1 The delivered LIMS should provide an easy way to determine if all requested analyses have been completed so that the sample can be assigned a discard or hold time.

5.2.2 HD

1 The delivered LIMS should allow users to designate how to dispose of samples.

5.2.2 HD

1 The LIMS should also have the capability to edit or extend the discard or hold time with a full audit trail.

5.2.2 HD

1 The delivered LIMS should also generate a discard list based on any defined parameter such as discard hold time, facility, sample point, how to dispose of sample, etc.

5.2.2 HD

QC Batch Preparation - Required in New LIMS

1 The delivered LIMS should permit user configuration to establish the QC requirements for the various method codes. It should be simple to design on-screen forms and printed documents that contain the type, frequency, and QC acceptance criteria for the particular analysis.

5.3.2 HD

1 The delivered LIMS should store pre-defined bench sheets for the formats currently in use with the capability for easy configuration of additional formats as needed.

5.3.2 D

1 Bench sheets should be identified by test code and the delivered LIMS should populate the sheets with samples selected by the analyst or samples available for preparation.

5.3.2 D

1 The delivered LIMS should have the ability to generate additional labels to be placed on prepared samples and QC in the batch.

5.3.2 D

1 Sample preparation batch sheets should include a mechanism for tracking all standard reference materials back to their original source.

5.3.2 D

1 The delivered LIMS should calculate spike levels for varying sample size.

5.3.2 D

1 Once a bench sheet is filled out, the delivered LIMS should allow editing of that bench sheet, including the ability to move QC in the run list and edit the frequency of the QC in the batch.

5.3.2 HD

1 The delivered LIMS shall have the capability to un-batch and re-batch analysis and prep batch run lists. The delivered LIMS shall allow for the re-prep, re-analysis, re-test, and re-sampling of a sample.

5.3.2 M

1 When a re-sampling event has been ordered, the delivered LIMS should automatically create another sample to be collected, designate that another bottle needs to be prepared and sent, annotate that the sample is a re-sample, associate the re-sample with the original sample collected, and notify designated personnel that a re-sampling is going to take place.

5.3.2 HD

1 The delivered LIMS should permit authorized personnel or the Quality Assurance (QA) Officer to assign QC requirements such as matrix spikes, spike duplicates, replicates, etc., to one or more samples, by parameter.

5.3.2 D

1 The delivered LIMS shall match individual samples with their respective QC batch and allow access to the associated QC results.

5.3.2 M

1 The delivered LIMS should provide a place for comments on the sample preparation worksheets to describe any unusual circumstances or pertinent information. These comments should be retrievable and associative to the data for which it was originally intended.

5.3.2 HD

1 The delivered LIMS shall have the capability of printing hard copies of the sample preparation worksheets, associated QC data, and associated comment fields.

5.3.2 M

1 The delivered LIMS should calculate QC summary statistics on a unique test or source. The user shall be able to select a date range or number of data points to be used.

5.3.2 HD

1 The delivered LIMS should allow the analyst to designate/assign a prep container number so that they can go back and look at all samples that were prepared in that container.

5.3.2 D

Sample Analysis and Data Entry - Required in New LIMS

1 The delivered LIMS shall provide the analyst with lists of pending work based on analysis/method codes.

5.4.2 M

1 The delivered LIMS should maintain a record of all standard reference materials used in the analytical process and provide a traceable record back to the source.

5.4.2 HD

1 The delivered LIMS shall accept input of analytical results several different ways: keyboard entry from personal computers, direct data input of instrument data files, data input from the third party software, barcode scanning, etc.

5.4.2 M

1 The delivered LIMS should have the capability of storing and associating digital pictures, graphics, chromatograms, etc., to the associated sample(s).

5.4.2 D

1 The delivered LIMS should have the capability of storing multiple runs for a single run list, allowing the analyst to select which result they want to accept.

5.4.2 HD

1 The delivered LIMS shall have the capability of rejecting a single analyte on a multi-analyte test without rejecting the entire test.

5.4.2 M

1 All data generated shall be retained by the delivered LIMS and shall be accessible by any authorized user.

5.4.2 M

1 Entry of default values defined by IL EPA personnel should be an easily assigned, multiple field data entry option.

5.4.2 HD

1 The delivered LIMS should calculate final reportable results from all sources of input of raw and measured data. Some tests require mathematical calculations to produce the final reportable results. The delivered LIMS should automatically take into account variables such as instrument calibration response, initial sample amount, final volume and dilutions when performing calculations.

5.4.2 HD

1 The delivered LIMS should convert all entered data and raw data to the correct final reporting units such as mg/L or ug/L using specific guidelines provided by the IL EPA regarding significant figures and rounding.

5.4.2 HD

1 The delivered LIMS should be configured to accept data files from laboratory instrumentation and other third party software programs and be provided turnkey, meaning that the functionality required will be delivered pre-configured, with designed reports, and capable of use in a production environment at the time of system acceptance.

5.4.2 HD

1 The delivered LIMS should have the ability to download lists (sequences) of samples for analysis. Instrument data should be read from files and automatically stored in the LIMS database in the same locations used for manually entered data.

5.4.2 HD

1 The delivered LIMS should receive electronic data input from numerous sources to accommodate not only the initial system configuration, but also future expansion as needs arise.

5.4.2 HD

1 The delivered LIMS shall have the flexibility and capability to add interfaced instruments to the LIMS.

5.4.2 M

1 The delivered LIMS should compare the final results to limits defined for that test. Should it find that a limit violation has occurred, the delivered LIMS should notify the analyst. The analyst should then be able to notify, via fax or email, the designated sampling or Bureau personnel.

5.4.2 HD

Quality Assurance/Quality Control - Required in New LIMS

1 The generated data should be subject to three mandatory levels of review, with the routine capability of a fourth and fifth level if necessary.

5.5.2 HD

1 The delivered LIMS shall provide information concerning the results for the target analytes and for the test code.

5.5.2 M

1 The delivered LIMS should track QC information such as Field Blanks (FB or Trip Blanks), Reagent Blanks (RB), duplicates, Matrix Spikes/Matrix Spike Duplicates (MS/MSD), check standards, and other user-defined QC requirements from the sample collection phase through analysis and QC review.

5.5.2 HD

1 The delivered LIMS should distinguish Field QC from other QC. 5.5.2 HD 1 The delivered LIMS shall automatically assign data qualifiers to

results based on criteria set forth by IL EPA. The delivered LIMS shall allow the analyst to manually edit or add additional data qualifiers, with full audit trail capabilities.

5.5.2 5.5.2.1

M

1 The delivered LIMS should be pre-configured to allow for a review process that incorporates password-based validation.

5.5.2 D

1 The delivered LIMS should recognize authorized passwords, and should maintain a trace-ability record of the review process.

5.5.2 HD

1 For each level of review, the delivered LIMS shall record the date, time, and identity of the reviewer.

5.5.2 M

1 The delivered LIMS should allow IL EPA to assign Bureau Program limits on a method basis and be flexible enough to allow changes to those limits, while maintaining the limits in place at the time of analysis with the samples analyzed.

5.5.2 HD

1 In cases where multiple parameters have been analyzed on a single sample, the delivered LIMS shall compare variables such as the total and dissolved solids results or calculate ion balance. The reviewer shall be able to set a reanalysis flag based on this review.

5.5.2 5.5.2.2

M

Levels of Review

1 The delivered LIMS should automatically flag data that exceeds a defined QC or program limit and notify designated IL EPA personnel that a limit was exceeded.

5.5.2.1 HD

1 The delivered LIMS should allow the analyst to review the data on a sample-by-sample basis, or on a batch basis. If the reviewer decides to review the data on a batch basis, the delivered LIMS should display, on one screen, all client and QC samples included in the batch.

5.5.2.1 HD

1 There should be a place for the analyst to write a short narrative to comment on any unusual circumstances or other pertinent information with the delivered LIMS.

5.5.2.1 HD

1 The decision to accept or reject the entire run or a portion of the run is made based on this review. The delivered LIMS should allow for the analyst to make this decision without impacting or otherwise disrupting the normal functioning of the LIMS.

5.5.2.1 HD

1 If errors are found or if something doesn't look right, the delivered LIMS should allow the reviewer to assign a "disputed" status. Samples with a "disputed" status should be sent to a Supervisor review step before proceeding to the Lab Manager review.

5.5.2.1 HD

1 The delivered LIMS should allow the reviewer to enter comments pertaining to the disputed data and should be readily available for the Supervisor reviewer.

5.5.2.1 HD

1 Additionally, the delivered LIMS should allow the reviewer to correct the error, send the data back to the previous level of review with comments, or schedule for either a re-prep or re-analysis.

5.5.2.1 HD

1 The reviewer shall also have the ability to approve partial data within the batch at this point and send it further along in the process with the delivered LIMS.

5.5.2.1 M

1 The LIMS should have the optional ability to add corrective comments to data sent back for re-prep or re-analysis.

5.5.2.1 HD

1 The delivered LIMS should allow IL EPA to designate a user(s), at the analysis level, as the Supervisor for that analysis.

5.5.2.1 HD

1 If the Supervisor deems the data to be valid, the delivered LIMS should allow the Supervisor to validate, in one motion, the entire batch and send it on to the Lab Manager, with comments describing the validation. If, however, the Supervisor finds an error or something doesn't look right, the delivered LIMS should allow the Supervisor to correct the error with full audit trail, send the data back to the analyst who performed the analysis by scheduling a re-prep or re-analysis, or schedule a re-sampling event. The delivered LIMS should allow the Supervisor to enter comments that pertain to this level of review.

5.5.2.1 HD

1 The delivered LIMS should permit the printing of a hardcopy of the review record if required.

5.5.2.1 HD

1 The delivered LIMS shall be capable of reporting data that is qualified as preliminary and subject to review. Preliminary data must be clearly identified as Preliminary on the report.

5.5.2.1 5.6.2

M

1 The delivered LIMS should provide Supervisors with the ability to simultaneously validate lower levels of validation while approving their own level.

5.5.2.1 HD

1 The delivered LIMS should allow each reviewer to correct or send the data back to the previous level of review or schedule for either a re-prep or re-analysis.

5.5.2.1 HD

1 The delivered LIMS should allow the Bureau to select all or a portion of the data to be passed on to the federal databases.

5.5.2.1 D

General QA/QC Requirements

1 The delivered LIMS should be pre-configured to automatically calculate and store within the LIMS, QC results in terms of percent recovery for calibration check standards, spiked samples, and the relative percent difference for duplicates.

5.5.2.2 HD

1 To facilitate the review process, the delivered LIMS should create and view control-charting data in order to readily access the established upper and lower control limits.

5.5.2.2 HD

1 The delivered LIMS should allow the analyst to select the final sample results to be reported, as well as indicate samples that must be re-run as a result of the QC review process. To facilitate the review process, the delivered LIMS should permit use of color to differentiate acceptance, warning, and rejection ranges.

5.5.2.2 HD

1 The delivered LIMS should create and view control charts. Data generated from the analyses should be automatically entered into the appropriate control charts. Resulting control limits should be readily accessible to the analyst and data reviewer with automatic updating of control limits.

5.5.2.2 HD

1 All control chart QC data should be available to authorized users in both graphical and tabular format and should be easily associated with the sample data that it represents.

5.5.2.2 HD

1 The delivered LIMS should store MDL and IDC studies within the LIMS. It should require that an analyst has an up to date and validated MDL and IDC before allowing the analyst to perform the analysis or prep method. The delivered LIMS should automatically schedule MDL and IDC studies when a due date threshold is reached.

5.5.2.2 HD

1 The appropriate Supervisor and analysts should be notified of due dates within a lead-time configurable by authorized LIMS users.

5.5.2.2 HD

1 The delivered LIMS should provide links to electronic documents that pertain to a test or method.

5.5.2.2 HD

1 The delivered LIMS should have the ability to electronically store a CAR and associate it to an individual analysis, batch or sample.

5.5.2.2 D

1 The delivered LIMS shall maintain audit trails of all activities pertaining to analysts, sample identifiers and results.

5.5.2.2 M

1 The LIMS should allow results editing even after a sample is completed and reported. Full EPA, GALP and NELAP audit trail requirements must be maintained.

5.5.2.2 HD

Report Generation - Required in New LIMS

1 As a minimum, the delivered LIMS should support Excel, and Oracle Discover as programs for report generation.

5.6.2 HD

1 The delivered LIMS shall come pre-configured with a minimum of 6-management reports standard to most laboratory environments as defined in Section 5.6.2.

5.6.2 M

1 The delivered LIMS should provide the means of designing multiple report formats to meet laboratory requirements.

5.6.2 HD

1 The delivered LIMS should provide query capabilities for the database and input information such as station location, program or funding code, sample identifiers, sample results, reporting limits, and QC data, in a totally configurable format.

5.6.2 HD

1 Reporting formats should be developed to include results for a single parameter or numerous test results on the same sheet. Final report formats should have flexibility and allow changes in report element sequence (e.g. organic elements to be reported in elution order or alphabetically). Reports should include comments pertaining to login, sample preparation, and analysis, along with sample results and QC.

5.6.2 HD

1 Authorized personnel shall be able, through password access, to edit any and all information included on the final report documents. The delivered LIMS shall maintain a record of all changes to data that have been entered through the use of audit trail functionality.

5.6.2 M

1 Electronic data deliverables of final and preliminary results should be available in a variety of final formats.

5.6.2 HD

1 Reports should be customizable to contain sample results only or to include QC data such as blank results, Laboratory Control Spike (LCS), matrix spikes, and duplicates.

5.6.2 HD

1 In the case where result data contains data qualifiers (defined by IL EPA), the report should include definitions of all qualifiers that were used.

5.6.2 HD

1 The delivered LIMS should store surrogate and internal standard data and should make the data available to be included on final reports.

5.6.2 D

1 The delivered LIMS should have the ability to include information regarding how reports are to be distributed, such as by fax, E-mail, or any special reporting requirements for mailing multiple copies.

5.6.2 D

1 Release of final reports shall be contingent upon approval by authorized laboratory personnel.

5.6.2 M

1 The delivered LIMS should provide the ability to combine various results from unrelated analyses for decisional purposes as well as reporting purposes (e.g. Ion Balance).

5.6.2 HD

1 The vendor should develop and deliver fifteen (15) additional client-requested reports prior to finalization of the LIMS (pre-"Go Live" date), and in accordance with provided formats. The vendor should also ensure that the IL EPA is supplied the training required to create new integrated reports.

5.6.2 HD

1 The delivered LIMS should store different formats of the same report and should allow users to select which report they would like to use. It should also allow the user to designate how many copies of the report they would like generated based on user-defined criteria.

5.6.2 HD

1 The delivered LIMS shall have the ability to automatically generate routine reports on a scheduled basis.

5.6.2 M

1 The delivered LIMS shall also have the ability to automatically generate and send a report when a triggered event such as a limit violation occurs in the LIMS.

5.6.2 M

1 The delivered LIMS should generate a "photocopy" of the final report in a format specified by IL EPA.

5.6.2 D

Standards and Reagents

1 Chemical standards information should be maintained in the delivered LIMS.

6.1 HD

1 The delivered LIMS should also provide the ability to track all standards from vendor receipt/creation to expiration or depletion, including all interactions between the two.

6.1 HD

1 The LIMS should provide for traceability from Inventory to Stock (Primary) Standards to Working (Secondary) Standards.

6.1 HD

1 Information about standards used in creating QC samples should be used by the LIMS to calculate QC results.

6.1 HD

Chemical Inventory

1 The delivered LIMS should maintain a Bar Coded inventory of all chemicals and supplies at each laboratory.

6.2 D

1 There should be a field provided in the LIMS Inventory module to scan this number into.

6.2 D

1 Once initial entry of a supply item has been accomplished, the LIMS should allow an analyst to subsequently decrement the quantity of an inventory item by simply scanning the Bar Code of that item.

6.2 D

1 The LIMS should provide a means of notifying the appropriate personnel of supplies needed, including all ordering information, based upon a set threshold trigger for each item in inventory.

6.2 D

Instrument Maintenance

1 The delivered LIMS should allow IL EPA personnel to schedule routine instrument maintenance and should notify designated personnel when maintenance is due.

6.3 D

GPS/GIS

1 The delivered LIMS should allow for users to input GPS/GIS, Latitude and Longitude.

6.4 D

Safety

1 The delivered LIMS should automatically schedule safety checks on a routine basis and should allow IL EPA to record information about the safety checks in the LIMS.

6.5 D

1,2 The delivered LIMS should have the ability to download/upload information pertaining to the safety checks from/to a hand held PDA.

6.5 D

1 The delivered LIMS should keep records of employee safety training and orientation. It should automatically schedule users for recurring training events and should incorporate a lead-time into the schedule.

6.5 D

1 The delivered LIMS should have the ability to record and track Incident/Accident reports and associate these reports to the user.

6.5 D

Accounting

1 The delivered LIMS shall be able to export data in a format designated by IL EPA to be used by external cost accounting software programs that contain all Funding Program account information as well as invoicing information.

6.6 M

1 The delivered LIMS should come pre-configured with invoicing functionality.

6.6 D

1 The delivered LIMS shall associate a sample to the Funding Program from which it was sampled.

6.6 M

1 The delivered LIMS should allow users to input the amount of time necessary to perform a test and should store this information in the LIMS.

6.6 D

Field Data Connectivity

1,2 The delivered LIMS should accept input of field data, either manually or electronically, before, during or after sample login, as field personnel might enter their own field test data before samples are sent to the lab.

6.7 D

Scheduling Tool

2 The delivered LIMS should provide a robust scheduling tool that allows for the integration of several schedules into one main schedule, while still allowing flexibility for ad Hoc changes.

6.8 D

2 Schedules should be capable of being set at different intervals. The schedule should be printable and capable of being faxed, e-mailed, etc.

6.8 D

Data Processing Environment Requirements

2 The delivered LIMS shall operate within the data processing environment of IL EPA and other EPA Divisional entities.

7 M

Server and Client Operating Systems

3,4 The vendor shall install the LIMS server code (if needed), on a single server located in the IL EPA facility.

7.1 M

2 All client machines used as System workstations will be configured using Novell on Microsoft Windows NT 4.0, 2000 or higher.

7.1 M

LIMS Data Storage

2 The vendor shall install, and the LIMS shall utilize, a central relational Oracle 8.1.7 or higher database to be located on an IL EPA Sun server running a Solaris 8.0 or higher operating system.

7.2 M

2 The IL EPA should be able to add additional tables to the delivered LIMS database without violating warranties or licensing agreements.

7.2 D

2 The delivered LIMS shall be installed by the vendor, and use the Oracle Database.

7.2 M

2 The delivered LIMS shall allow multiple users to access the data simultaneously for data entry and retrieval without locking each other out.

7.2 M

2 The vendor shall provide any necessary drivers for interaction between the user interface and the delivered LIMS database.

7.2 M

2,4 The central database should be provided complete with tools for database management, archiving, and restoring from archive capabilities.

7.2 D

Office Applications

2 The delivered LIMS should support transfer of data between the LIMS and office automation products via Dynamic Data Exchange (DDE) or Object Linking and Embedding (OLE2).

7.4 D

Data Backup and Storage

2 The delivered LIMS must be able to duplicate the monthly report file procedure as well as storing the resulting ASCII file on retrievable write once media outside the database architecture.

7.6

M

2 The delivered LIMS should support migration of data from the active database to a data warehouse.

7.7

D

Documentation

1,2 For the IL EPA delivered LIMS, all data entry fields in the user manual/documentation shall identify permitted data types, permitted ranges of variables, and relationships with other data.

8.3 M

1,2 Delivery of the LIMS should include delivery of all source code for database development and the user interface as well as any auxiliary programs integrated into the LIMS.

8.3 D

Required in New LIMS Completion Date

3 The LIMS should be installed and fully functioning by June 2003.

8.4 HD

Warranties/Guarantees

2 IL EPA requires that the proposed LIMS shall be provided with a 12-month initial warranty from the date of final agency acceptance.

8.5.2 M