Illinois Environmental Protection Agency

LIMS Description of Services

Version 2.1

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TABLE OF CONTENTS

1. PROJECT DESCRIPTION ............................................................. 4 1.1. BACKGROUND ..................................................................................................................................4 2. SOFTWARE / INFRASTRUCTURE BOUNDARIES ............................. 5

2.1 Network Server ....................................................................................................................5 2.2 Web Servers .........................................................................................................................5 2.3 Database...............................................................................................................................5 2.4 E-mail ....................................................................................................................................5

3. GENERAL FUNCTIONAL REQUIREMENTS ...................................... 6 3.1. CONTRACT PERFORMANCE.............................................................................................................6 4. GENERAL SYSTEM REQUIREMENTS ............................................. 6 4.1. LIMS DESIGN .................................................................................................................................6

4.1.1 Clock.....................................................................................................................................7 4.2. SYSTEM SECURITY ...........................................................................................................................7

4.2.1 Central Database Security..................................................................................................7 4.2.2 LIMS Application Security...................................................................................................7 4.2.3 Server Resources Security .................................................................................................7

4.3. EXTERNAL APPLICATION INTERACTION .............................................................................................7 4.3.1 E-mail ....................................................................................................................................8

4.4. ELECTRONIC DATA DELIVERABLES ....................................................................................................8 4.5. USE OF BAR CODES ..................................................................................................... 9 4.6. LIMS DOCUMENTATION...................................................................................................................9 4.7. SYSTEM ADMINISTRATION................................................................................................................9 4.8. LIMS WARRANTY AND SUPPORT......................................................................................................9

4.8.1 On-Site Support .....................................................................................................................9

5. IL EPA OPERATIONS.............................................................. 10 5.1. SAMPLE CREATION AND LOGIN .......................................................................................................10

5.1.1. Current ................................................................................................................................10 5.1.2. Required in New LIMS ......................................................................................................11

5.2. WORKLOAD MANAGEMENT .............................................................................................................13 5.2.1. Current ................................................................................................................................13 5.2.2. Required in New LIMS ......................................................................................................14

5.3. QC BATCH PREPARATION...............................................................................................................15 5.3.1. Current ................................................................................................................................15 5.3.2. Required in New LIMS ......................................................................................................15

5.4. SAMPLE ANALYSIS AND DATA ENTRY ..............................................................................................16 5.4.1. Current ................................................................................................................................16 5.4.2. Required in New LIMS ......................................................................................................17

5.5. QUALITY ASSURANCE/QUALITY CONTROL .......................................................................................18 5.5.1. Current ................................................................................................................................18 5.5.2. Required in New LIMS ......................................................................................................19

5.6. REPORT GENERATION ....................................................................................................................22

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5.6.1. Current ................................................................................................................................22 5.6.2. Required in New LIMS ......................................................................................................23

6. LABORATORY SUPPORT ........................................................... 24 6.1. STANDARDS AND REAGENTS ...........................................................................................................24 6.2. CHEMICAL INVENTORY ...................................................................................................................25 6.3. INSTRUMENT MAINTENANCE...........................................................................................................25 6.4. GPS/GIS ......................................................................................................................................25 6.5. SAFETY..........................................................................................................................................25 6.6. ACCOUNTING .................................................................................................................................26 6.7. FIELD DATA CONNECTIVITY ...........................................................................................................26 6.8. SCHEDULING TOOL ........................................................................................................................26 7. DATA PROCESSING ENVIRONMENT REQUIREMENTS................... 26 7.1. SERVER AND CLIENT OPERATING SYSTEMS .....................................................................................27 7.2. LIMS DATA STORAGE....................................................................................................................27 7.3. WAN / LAN .................................................................................................................................27 7.4. OFFICE APPLICATIONS ...................................................................................................................27 7.5. DATA BACKUP AND STORAGE..........................................................................................................27 7.6. MONTHLY REPORT FILE PROCEDURE...........................................................................................27 7.7. HISTORICAL DATA .......................................................................................................................27

8. PERFORMANCE REQUIREMENTS & NEW LIMS.......................... 28 8.1. INSTALLATION ...............................................................................................................................28 8.2. TRAINING ......................................................................................................................................28 8.3. DOCUMENTATION...........................................................................................................................28 8.4. REQUIRED NEW LIMS COMPLETION DATE .....................................................................................29 8.5. MAINTENANCE AND WARRANTIES ...................................................................................................29

8.5.1. Maintenance Options ........................................................................................................29 8.5.2. Warranties/Guarantees.....................................................................................................29

8.6. INSTRUCTIONS TO PROPOSERS.......................................................................................................29 APPENDIX I - ACRONYMS .............................................................. 31 APPENDIX I - ACRONYMS (CONTINUED) ......................................... 32

Attachment Appendices Appendix II - Reports Appendix A - Summary of Requirements Appendix B - Current Stripper Program File Appendix C - Program Database Table Descriptions / Definitions Appendix D - Monthly Report File Procedures

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1. Project Description The State of Illinois Environmental Protection Agency (IL EPA) intends to purchase a single Laboratory Information Management System (LIMS), to include software, implementation support and data conversion tasks, as part of an ongoing program to improve efficiency in their laboratories. This document includes information about the IL EPA facilities and details specific requirements for responding to the Request For Proposal (RFP) to provide LIMS software, associated hardware, implementation support, and data conversion services. Proposals shall deal with the immediate needs of the IL EPA and the long-term goals of the organization as set forth in this document.

The IL EPA is currently using a proprietary DOS based LIMS (Perkin Elmer 2000). It does not support many regulatory requirements and does not provide the laboratory visibility and automation needs that most modern LIMS are designed and typically implemented to provide. 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.

1.1. Background The IL EPA Division of Laboratories is comprised of two laboratories, an Organic Laboratory in Springfield, IL and an Inorganic Laboratory in Champaign, IL, that operate independently of each other. Currently, the two laboratories share the same sample numbering format, but they do not share the same numbering system.

Each laboratory includes a login group, a prep group(s), and analysis group(s). Together, they support the activities of the Bureau of Water (BOW), Bureau of Land (BOL), and Bureau of Air (BOA) who collect and submit samples in coordination with Federal and State Environmental Programs delegated to Illinois by the US EPA. About 85% of all samples received by the two laboratories come from the BOW, while 10% comes from the BOL and 5% from the BOA. The laboratories also receive a small amount of samples from the Office of Emergency Response (OER), who respond to emergencies such as train wrecks, spills, etc.

Each Bureau is in charge of implementing programs that help the IL EPA obtain its goals of a clean and safe environment, while following Federal and State Environmental Programs.

The BOA is in charge of implementing and maintaining the Clean Air Program, as part of the Clean Air Act (CAA). They have organized themselves into five priority program

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areas: Ozone, Title V Program Implementation, Air Toxics, Compliance, and Base Programs and National/Regional Priorities.

The BOL is in charge of implementing and maintaining the Clean Land Program, as part of the Resource Conservation and Recovery Act (RCRA), the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), and other Federal and State Environmental Programs. To achieve its goals, the BOL has divided its resources into six broad environmental focus areas, which encompass seventeen (17) BOL programs. The six areas are: Hazardous Waste Management, Non-hazardous Waste Management, Federal Cleanups, State Cleanups, Leaking Underground Storage Tank Cleanups and Other Environmental Areas.

The BOW is in charge of implementing and maintaining the Clean and Safe Drinking Water Programs as defined by the Clean Water Act (CWA), National Pollutant Discharge Elimination System (NPDES), Safe Drinking Water Act (SDWA), and other Federal and State Environmental Programs. To fully address all aspects of the water resource protection and management, the BOW is divided into two primary areas, Water Pollution Control (WPC) and Public Water Supplies (PWS). Source Water Assessment and Protection (SWAP), a program administered under PWS, is concerned with the protection of potable water resources, which include groundwater and surface water supplies, and, therefore, has some concerns addressed by both WPC and PWS.

Collectively, each Bureau is working to provide the State of Illinois with cleaner air, land and water.

2. Software / Infrastructure Boundaries This RFP is provided specifically to help define LIMS software and related services and hardware to support the laboratory enterprise. Any proposal submitted shall also identify hardware and infrastructure requirements to support the laboratory enterprise. The IL EPA will provide all necessary infrastructure components required by the proposed LIMS. The proposer shall identify any specific hardware (other than client PC’s) required to support the LIMS being proposed.

2.1 Network Server Describe the print services architecture(s) your proposed LIMS will run under.

2.2 Web Servers The Internet application server is Oracle 9iAS. The IL EPA Internet web server is iPlanet.

2.3 Database 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. Database backups are managed with Oracle Corporation’s RMAN and Tivoli’s Storage Management (TSM).

2.4 E-mail The IL EPA uses Groupwise and SMTP for electronic mail (e-mail) services.

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3. General Functional Requirements This section identifies requirements or constraints that apply to the entire IL EPA LIMS, herein referred to as ‘the LIMS’. The LIMS includes any and all software, hardware and services delivered as a whole or as component parts of the proposed LIMS.

Requirements are classified as:

MANDATORY (M) - These requirements are mandatory

HIGHLY DESIRABLE (HD) - These requirements are highly desirable

DESIRABLE (D) - These requirements are desirable

3.1. Contract Performance The LIMS should be available for full production use by June 2003. Proposals shall include a detailed project plan and a proposed project schedule indicating the major tasks (including significant milestones necessary for an on time, within budget, and fully functional implementation).

Upon installation of LIMS and user training completion, IL EPA will test the system using criteria from ASTM Standards E1578-93 (1999) Standard Guide for Laboratory Information Systems (LIMS) and E2066-00 Standard Guide for Validation of Laboratory Information Systems (LIMS). The testing of the system will occur prior to acceptance of the LIMS by IL EPA.

4. General System Requirements This section identifies requirements or constraints that apply to the entire Laboratory Enterprise System, herein referred to as the “LIMS”. The LIMS includes any and all software delivered as a whole or as component parts of the proposed system.

4.1. LIMS Design The primary design of the delivered LIMS should be thin client (browser based) utilizing Oracle 9iAS as the Internet application server. The system shall allow a minimum of 25 simultaneous users without degradation of system performance. The delivered LIMS should be pre-configured with an auto logoff capability that logs a user off the system after a period of inactivity. The proposer shall include in the proposal for the LIMS, any licensing options that are available and will support the required number of users. The term “user” is defined for purposes of this proposal and any ensuing contract as laboratory personnel actively addressing the main LIMS application. It does not include instrument interfaces, persons accessing finished data, peripheral devices, or background jobs.

Additionally, 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. All network applications must support Transmission Control Protocol/Internet Protocol (TCP/IP) standards.

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

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industry-standard, commercially available components and tools such as visual basic and HTML/ASP editors. Additionally, the design and placement of objects on the user interface screens shall also be configurable using the tools listed above. The use of proprietary tools and components will not be considered.

4.1.1 Clock The delivered LIMS must utilize a true 24-hour clock.

4.2. System Security The delivered LIMS shall provide security to protect the integrity of the data. The security measures shall be compatible with Novell networking, Sun Solaris, Oracle, Internet Explorer, and Windows NT or 2000. The levels of security are described in the following sections.

4.2.1 Central Database Security 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. This 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.

4.2.2 LIMS Application Security The delivered LIMS application shall provide configurable security for all users of the application, whether internal to IL EPA or external. 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. User security shall be configurable by IL EPA LIMS administrative personnel.

Additionally, IL EPA is considering other Agency systems that utilize Entrust PKI technology with an Oracle portal and single sign-on. The delivered LIMS should have the ability to access network resources utilizing the Entrust PKI technology.

4.2.3 Server Resources Security The delivered LIMS shall include configurable security for access to network resources such as printers, directories, and files. The delivered LIMS should use the existing Novell and Oracle security functions.

4.3. External Application Interaction The delivered LIMS shall interact with the IL EPA’s major applications listed below. Additionally, the delivered LIMS shall be open database connectivity (ODBC) compliant.

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4.3.1 E-mail 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.

4.4. Electronic Data Deliverables The IL EPA has many Program databases that they are responsible for entering data into including but not limited to, Agency Compliance and Enforcement System (ACES), Land Groundwater Sample Format, Safe Drinking Water Information System (SDWIS), Storage and Retrieval (STORET), FOS Effluent Grab Samples (for PCS), Integrated Comprehensive Environmental Management System (ICEMAN/AIRS), and Illinois Fluoridating Reporting System (IFRS). Currently, an Electronic Data Deliverable (EDD) is extracted from the LIMS by a program called STRIPPER and flags them as being extracted. The STRIPPER program sorts through the data and produces electronic deliverables that feed the other Program databases as described below. The delivered LIMS shall be pre-configured with the capability to create EDD(s) and flag the selected samples as transferred.

In many instances IL EPA personnel first create sampling events or schedules in the Program databases. This information is later merged with specific analysis and sample information “Stripped” from the LIMS. Much of the information that they enter is demographic in nature and not needed at the time of sample submission. The delivered LIMS should be pre-configured to accept EDDs from program databases and use the information to update the LIMS database. 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.

The delivered LIMS vendor must perform the analysis, design, development and implementation of the EDD or EDDs to feed these programmatic systems. The vendor will create a common EDD file that contains all the elements needed by the program databases mentioned above or the individual EDDs defined in Appendix C. While these fields are required to be available in the LIMS database, they shall not be mandatory to complete throughput of samples and sample data. Field lengths must accommodate the most restrictive definitions in Appendix C. Additionally the EDDs extraction format modules shall not be written in a proprietary language and be able to be modified or maintained by IEPA IT staff for future modification or addition of new EDD formats and data transfers.

The delivered LIMS should also be pre-configured to create and receive EDDs for instrumentation, hand held Personal Digital Assistant (PDAs), other programs and other devices. If the LIMS does not have the capability of generating EDDs internally, it must be able to import/export data to an external resource for EDD preparation. Any data that are available on hardcopy reports may be required on the EDDs. It shall also be possible to manually enter data for EDD submittal that is not tracked by the LIMS. The EDDs shall not be written in a proprietary language. It is incumbent on the LIMS provider to address these matters and explain how a mechanism for EDD generation and delivery will function to accomplish these requirements.

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4.5. Use of Bar Codes 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. The delivered LIMS shall generate bar code labels of various sizes, with mixed text and barcodes, for use in sample and batch identification and any other areas where bar code labels will enhance user productivity. Use of barcodes shall encompass all aspects of chain of custody trail both internal and external to the laboratory.

4.6. LIMS Documentation 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.

In concert with the design specification, the vendor shall provide a prototype of the user interface to demonstrate methodology and style of the screens. This prototype does not have to include all screens in the delivered LIMS, but a representative sample of the different screen paradigms to be used. The vendor shall also provide prototypes of various reports to be generated by the delivered LIMS.

In addition to the design specification, the final implementation of the LIMS shall include specific information about each screen of the application. The proposer shall submit a training plan with this RFP and must include the course title, a summary of content, and state the position/qualifications of the target audience.

4.7. System Administration 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. The delivered LIMS should not rely on proprietary technology or components. The vendor shall supply as part of the delivered LIMS, any of the above listed hardware or third party software.

4.8. LIMS Warranty and Support Basic Warranty and Support requirements are listed in the Request for Proposal document, STANDARD TERMS, CONDITIONS AND CERTIFICATIONS, section 15.

Additionally, the proposer shall define in the proposal the boundaries of the LIMS warranty. At a minimum, the delivered LIMS shall be warranted against deficiencies in functionality (as defined in the approved design specification) and defects in operation for a period of one year from the date of the IL EPA’s acceptance of the fully operational LIMS. Any custom coding performed by the vendor shall also be warranted against deficiencies.

The vendor shall be capable of providing technical support through the following means:

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4.8.1 On-Site Support 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.

5. IL EPA Operations This section describes all current aspects of IL EPA operations as well as how the delivered LIMS shall function as an integral part of the overall IL EPA process. 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. The delivered LIMS shall serve as a tool to correct many of the inefficiencies that are identified in the operations descriptions that follow.

5.1. Sample Creation and Login

5.1.1. Current Sampling events are initiated by the Bureau of Water, Bureau of Land and Bureau of Air, as part of State and Federal Environmental Programs for the State of Illinois. Depending on the program, the ordering of bottles occurs at different frequencies. Sampling events (test requests) are sent from the Bureaus to the IL EPA headquarters where shipping labels and Chain of Custodies (COC) are generated. For some programs, headquarters forwards the shipping labels and Chain of Custodies to the laboratory that is going to process the samples. The laboratories that receive the order prepare sample bottles with blank labels, including field Quality Control (QC) samples, to be shipped in kits to the sampling personnel. In other programs, field personnel receive the COC, fill it out, and submit the completed forms to the laboratory with the samples.

Sampling personnel also generate their own COC, which they take into the field with them. Sampling personnel utilize multi-parameter probes to collect and record field test data. Multi-parameter probes are sensors that are used to gather information about water sources. The instruments measure multiple parameters simultaneously and depending on the probe, can collect information such as temperature, pH, conductivity, dissolved oxygen, depth, turbidity, total dissolved gas, ammonia, nitrate, chloride, ambient light and chlorophyll. In other instances, sampling personnel may collect and record field data into a laptop computer that is taken into the field. The IL EPA is also considering purchasing handheld PDAs for sampling personnel to collect field data with. The field data is then recorded on their Chain of Custody along with demographic information about the site, and is submitted with the samples.

Laboratory login personnel receive the samples and assign a sequential laboratory number to the samples. The numbering system is a seven-digit alphanumeric that distinguishes samples from the two laboratories. An example of a sample number is shown below.

D200001

D – Laboratory / Analytical Section

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2 – Year

00001 – Incremented Number

The first character is an alpha character that initially distinguishes where the sample is tested. IL EPA uses four alpha characters at the beginning of the sample number and they are A, B, C, and D. The D designates samples that are tested in Springfield while A, B, and C designate samples that are tested in Champaign. In the Champaign laboratory, the alpha characters are used to further distinguish the analytical section in which the samples are tested. The next character designates the year the sample is collected. The last five characters are incremented numbers.

Information from the COC, such as the field test results and demographic data, are logged (written) into a logbook and also manually logged into LIMS. The same Login personnel perform chlorine residual, pH, and temperature tests when required, when samples arrive. Based on these tests, laboratory login personnel may accept or reject the samples. Upon rejection of a sample, laboratory login personnel may schedule a re-sampling, depending on the sampling program, by preparing bottles and generating documentation stating why a re-sampling is necessary. The bottles and documentation are sent to the party that submitted the initial sample.

Laboratory login personnel determine where in the laboratory samples are to be stored, based on the funding code. The funding code defines the program from which the samples came. Each funding code can have multiple clients and based on the client, laboratory login personnel can tell where the sample needs to be stored.

As such, certain programs require that samples be tracked through the laboratory via an internal COC. The laboratories have sample custodians, which are in charge of signing samples into and out of the storage coolers.

5.1.2. Required in New LIMS 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. 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. The IL EPA Bureaus collect samples in coordination with other State and Federal Agencies and as such, samples are analyzed for the same tests by different laboratories. To indicate that a particular sample is also being tested elsewhere, IL EPA designates that those samples are “Split” samples. 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.

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. Once samples are selected, 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. It shall include the Field QC on the COC and shall generate labels for them as well.

In addition to a generic Chain of Custody that shall be used for unscheduled or occasional sample deliveries, the delivered LIMS should generate a partially completed

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COC and bar coded sample tags to be sent out with the bottles. The COC and sample tags shall be easily customizable to allow for a number of different formats specific to the various IL EPA activities. The COC shall be designed so that sampling personnel can record field test results on it. The delivered LIMS should be capable of uploading electronic data from probes, handhelds, etc. and later associate the data to the correct sample(s).

During the login process, information is taken from the COC and entered into the delivered LIMS database. In the case of preprinted COCs created from pre-scheduled events, the sampling sites are confirmed and any remaining data, such as date of collection, time of collection, and field collection comments, are completed. The delivered LIMS shall have the ability to specify that no date or time of sample collection was provided. 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. The delivered LIMS should be configured to allow login personnel to create a COC and labels when samples are received without any.

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. 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.

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. 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. Additionally, the delivered LIMS shall allow IL EPA personnel to add tests at a later date with full audit trail. The delivered LIMS shall also allow for canceling of an entire sample with full audit trail

The delivered LIMS should maintain a distinct, sequential sample numbering system that would permit distinction between the laboratories. The LIMS shall provide the Springfield and Champaign laboratories with a means of distinguishing which samples are theirs. Each sample shall be assigned a unique number. The delivered LIMS shall generate sample identifiers for all fractions received.

During login, the appropriate test codes shall be assigned for each sample and any sample fraction, based on the COC and/or pre-scheduled requirements. 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.

The delivered LIMS shall allow login personnel to flag a sample, or groups 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 sample. The delivered LIMS should allow login personnel to flag a sample and add comments that follow the sample throughout all statuses, if the sample

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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.

Some of the samples that IL EPA performs analyses on have conditional criteria that must be met for the analyses to be considered valid. Laboratory login personnel are required to perform pH, temperature, and residual chlorine on samples as they are received. The delivered LIMS should have a place at the test or analysis level to define and enter configurable limits for the conditional criteria. 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. Remaining analyses for the sample, whose condition limits have been met, shall pass through Login with no flagging or required decisional actions.

The delivered LIMS shall have a place for "comments" that are communicated throughout the System to authorized analysts, management and end-users. These comments shall be used to describe any unusual circumstances or special requests observed during login or noted on the COC. A client or sampler may want the analyst to be aware of certain information, request special sample preparation, or designate samples to use for matrix spikes. The delivered LIMS should also allow for multiple levels of comments. All comments fields shall allow for pre-configured editable comments as well as Free-text entry.

The delivered LIMS shall have the capability of maintaining an internal chain of custody for samples that require it. The delivered LIMS should allow/require login personnel to designate where a sample is being stored, as part of the login process. The Funding Code or comments on the COC may define whether a sample requires internal tracking.

5.2. Workload Management

5.2.1. Current The laboratories record COC information manually as well as entering the information into LIMS.

In the Springfield laboratory, the COC information is copied by hand onto a clipboard in the sample receiving area. This is done because sometimes the analyst is ready for the samples before login personnel can enter the data into LIMS. The prep group supervisor will go to the login clipboard and manually copy sample information to additional clipboards. The prep group supervisor maintains three clipboards, one for each analytical preparation section. The supervisor will then manually assign a prep to an analyst through oral communication.

In the Champaign laboratory, the COCs are hole-punched and stored on a clipboard. Laboratory login personnel immediately enter the COC information into LIMS. The prep analysts generate a list of samples from LIMS and sort through the list to find samples that are ready for prep. The list that is generated includes all samples that are in the LIMS and does not sort them based on a priority status.

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Laboratory personnel keep track of sample hold times and turnaround times by manually checking logbooks, checking LIMS, and by communicating with others in the laboratory. Tracking the sample status in the laboratory and in the review process is done manually by looking at logbooks and walking around the laboratory asking the analysts.

Management reports are done manually as supervisors and analysts go through logbooks and clipboards, counting samples received, analyzed, and reported.

5.2.2. Required in New LIMS The delivered LIMS shall produce work-lists and management reports (both on-screen and printable). The delivered LIMS should provide information concerning the samples in the LIMS in order for laboratory personnel to schedule work. The delivered LIMS shall be pre-configured to query the database by test code, group of test codes, or by analytical section. 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. The work lists shall be easily configurable depending on the laboratory's requirements. From the lists, the analysts should be able to select samples to be processed and generate QC batch worksheets. 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. The delivered LIMS should noticeably distinguish samples that have been flagged as potentially hazardous.

The delivered LIMS should keep track of prep and analysis hold times in units of hours and days and shall distinguish between the two hold times. The overall hold time should be the sum of the prep and analysis hold times. 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. The on-screen display should include a user-controlled filter to help define the format of the criteria of the listed samples. 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 specified threshold is reached.

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

The displayed status report shall also include the level of QC review. The delivered LIMS shall allow the analysts the ability to change the status of the sample.

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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. The delivered LIMS should allow users to designate how to dispose of samples. The LIMS should also have the capability to edit or extend the discard or hold time with a full audit trail. 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.

5.3. QC Batch Preparation

5.3.1. Current Quality assurance is described in the IL EPA QAP. QC requirements will be found in the reference methods or will be configured by authorized laboratory personnel.

Samples are prepared and analyzed on a batch basis. The first step in creating a QC batch is to gather sample information from either the LIMS or the login area. The Champaign and Springfield laboratories store sample information differently, however, the preparation steps are similar.

Batches include samples, Field QC such as Trip Blanks, and laboratory QC such as RB (Reagent Blanks) and MS/MSD (Matrix Spike/Matrix Spike Duplicate). Some samples require a preparation step, while others do not. For samples that require a preparation step, analysts print a list of samples that are in LIMS (Champaign) or they go to a clipboard that has a list of samples that are waiting to be prepared (Springfield). Currently, the lists that are printed from LIMS are not very useful because they list all samples that are in-house and not just samples ready for prep. Analysts manually search through the list to find samples that are ready to be prepared. Analysts copy sample information to a prep worksheet where laboratory QC is added to the batch manually. The prep worksheet is passed on to the analysts who perform the analysis (Champaign) or sample prep information is copied from the prep worksheet into a prep logbook (Springfield) and the samples are stored waiting for analysis.

5.3.2. Required in New LIMS Samples shall be prepared in batches that include the appropriate QC indicators specific to each analysis method. 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. There are distinct batch preparation sheets (bench sheets) for each analysis used by the laboratory. 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. 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. Analysts shall have the capability to select any or all available samples to be included. These sheets shall contain basic information about the sample preparation such as, but not limited to, analyst name, date, time, method code, sample number, sample size, final volume, dilutions, QC samples, and spike amounts. The delivered LIMS should have the ability to generate additional labels to be placed on prepared samples and QC in the batch.

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Sample preparation bench sheets should include a mechanism for tracking all standard reference materials back to their original source. The delivered LIMS should calculate spike levels for varying sample size. 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. 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. 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.

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.

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

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

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.

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.

5.4. Sample Analysis and Data Entry

5.4.1. Current Analysts gather the prepared samples and begin creating a run list (sequence list). In some cases, the prep bench sheet will double as the run list. If not, the analyst must go to the prep logbook and copy information about the sample preparation onto their run list. In either case, the analyst must add instrument QC such as calibration standards onto their run list.

For samples with no prep, analysts create their run lists from the sample receipt clipboard (Springfield) or from lists printed from LIMS (Champaign), adding laboratory and instrument QC as necessary.

In Springfield, samples are analyzed and raw result data is sent to a Hewlett-Packard ChemServer and processed using ThruPut’s Target software. Final results are printed from Chemserver and the data is then manually entered into LIMS.

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In Champaign, samples are analyzed and raw result data is processed using third party software on the PC attached to the instrument. Final results are printed and the data is manually entered into LIMS

The Champaign laboratory is currently under contract with Labtronix to have its instruments interfaced with their current LIMS. The intent is to also contract Labtronix to interface their instruments to the new LIMS. The Springfield laboratory will continue to process instrument data through third party software.

5.4.2. Required in New LIMS The delivered LIMS shall provide the analyst with lists of pending work based on analysis/method codes. In some cases, the analytical run sequences shall be determined by the batch preparation worksheets. Instrument calibrations and other method requirements will be performed in accordance with the established Standard Operating Procedure (SOP) for that method. 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. 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 third party software, barcode scanning, etc. In any case, analysts shall have access to the batch preparation bench sheets that are used to set up the analytical run log sequence.

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

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

All data generated shall be retained by the delivered LIMS and shall be accessible by any authorized user. Entry of default values, defined by IL EPA personnel should be an easily assigned, multiple field data entry option.

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.

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.

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. The delivered LIMS should have the ability to download lists (sequences) of

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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. 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. Since it is difficult for the laboratory to predict future requirements, the delivered LIMS shall have the flexibility and capability to add interfaced instruments to the LIMS.

Upon entry and calculation of final results, 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.

5.5. Quality Assurance/Quality Control The IL EPA Quality Assurance Plan (QAP) prescribes the protocols that are followed to ensure the quality of the analytical data produced by the laboratory.

5.5.1. Current The review of final results is a four-step process. The first two steps are performed by analysts and are done on a batch basis. The last two steps are performed by supervisors and are done on a sample basis.

Data is integrated/quantitated at the instrument or on a server using third party software, depending on the laboratory. It is at this point that the analyst does the initial review of the data. It is also at this point, that the analyst manually applies data qualifiers to the data. The analyst has the ability to assign a number of qualifiers to a single sample. The data is then passed on for peer review where a different analyst reviews the work (hardcopy), checking QC and any calculations. If any discrepancies are found, the reviewer passes the data back to the Analyst who originally did the work and indicates the corrections that need to be made. Upon peer review approval, the data is sent on to a Supervisor. The Supervisor checks the calculations and reviews the QC. Upon approval at the Supervisor level, the data is passed on to the Lab Supervisor where the data gets its final approval. The analyst manually qualifies data and flags samples that exceed a limit. When a sample exceeds a limit, the analyst notifies their supervisor of the violation. The supervisor notifies the submitting party of the violation via a phone call or an email.

Tracking sample and analyst information for audit trail purposes is done manually through the use of logbooks and other worksheets.

In order for analysts to be allowed to perform a particular analysis, they must have completed and passed Method Detection Limit (MDL) and Initial Demonstration of Competency (IDC) studies. Maintaining, scheduling, and tracking of the studies is done manually and kept on paper.

Tracking a sample’s status through the laboratory is done manually and through oral communications. Most times, a supervisor walks through the laboratory and inquires as to where a sample is in the analysis process.

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5.5.2. Required in New LIMS The generated data should be subject to three mandatory levels of review, with the routine capability of a fourth and fifth level if necessary. The reviewer shall access data through the delivered LIMS to validate the sample results for a given QC batch. First, it shall list the analyses requested for each sample and view any other information noted during login or attached to the sample group. The delivered LIMS shall provide information concerning the results for the target analytes and for the test code. 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. The delivered LIMS should distinguish Field QC from other QC. 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.

The delivered LIMS should be pre-configured to allow for a review process that incorporates password-based validation. Only designated personnel shall be authorized to conduct data review for the different levels. The delivered LIMS should recognize authorized passwords, and should maintain a trace-ability record of the review process. For each level of review, the delivered LIMS shall record the date, time, and identity of the reviewer.

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

5.5.2.1. Levels of Review

LEVEL 1 – Analyst (Laboratory) The analyst who generates the analytical data has the prime responsibility for the correctness and completeness of the data. 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. Upon calculation of final results, the delivered LIMS shall automatically assign data qualifiers 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.

Upon completion of the instrument run or the manual batch entry, the analyst will review the results. 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. The analyst reviews quality control data, calibrations, spike recoveries, matrix difficulties, method detection limits, deviations from the SOPs, and comments about the sample that have been carried through the system or unusual circumstances that may have occurred. There should be a place for the analyst to write a short narrative to comment on any unusual circumstances or other pertinent

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information with the delivered LIMS. 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. The Level 1 review is documented, dated and accepted by the analyst.

LEVEL 2 – Peer review (Laboratory) The next step in the IL EPA validation process shall include a peer review by an analyst who was not directly involved in the analysis. This analyst looks over the data and checks the calibrations, calculations, and other QC data. The delivered LIMS shall 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 shall display, on one screen, all client and QC samples included in the batch. If no mistakes are found, the reviewer selects the approval option on the screen and s ends the data to the Lab Manager for final approval. 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. The delivered LIMS should allow the reviewer to enter comments pertaining to the disputed data and should be readily available for the Supervisor reviewer. 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. 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. The LIMS should have the optional ability to add corrective comments to data sent back for re-prep or re-analysis.

LEVEL 3 – Supervisor (Laboratory) Only disputed data shall be subject to this level of review. Data that has been disputed by the Peer Reviewer shall be sent to designate IL EPA personnel for a Supervisor review. The delivered LIMS should allow IL EPA to designate a user(s), at the analysis level, as the Supervisor for that analysis.

The Supervisor looks over the data and checks the calibrations, calculations, and other QC data and reviews the comments entered by the peer reviewer. The delivered LIMS shall allow the Supervisor to review the data on a sample-by-sample basis, or on a batch basis. If the Supervisor decides to review the data on a batch basis, the delivered LIMS shall display, on one screen, all client and QC samples included in the batch. 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 that 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.

LEVEL 4 – Lab Manager (Laboratory) The final laboratory level of the review process is the responsibility of the Laboratory Supervisor. If differences are noted, a thorough review of all data is conducted before

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the final release of the report. The laboratory Supervisor shall have automatic, quick access to all quality control data such as calibration information, spike recoveries, blank results, method detection and method reporting limits, surrogate values, dilutions, and comments on unusual circumstances or deviations from the SOPs that may have occurred.

The delivered LIMS should permit the printing of a hardcopy of the review record if required. Analytical results are considered valid when accuracy and precision, as well as calibration data meet the criteria set forth in the IL EPA Laboratory QAP.

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 re-analysis flag based on this view.

There may be a need to occasionally report samples prior to full review and validation. 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.

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

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.

LEVEL 5 – Bureau (Bureau) The final step in the IL EPA review process occurs outside the laboratory and is not a part of the validation of laboratory data. It is a review of the final results data by the Bureau or designated personnel from which the samples originated before it is sent to other databases. This level of review looks over the data and its qualifiers and decides whether to send the data on to the federal program databases. The delivered LIMS should allow the Bureau to select all or a portion of the data to be passed on to the federal databases.

5.5.2.2. General QC/QA Requirements 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. The latter may be applicable to sample duplicates or matrix spike duplicates. 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. 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. 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 analysts and data reviewer with automatic updating of control limits. Control charts are also used to track trends and validate results. All control-chart QC data should be available to authorized users in both

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graphical and tabular format and should be easily associated with the sample data that it represents. Proposers shall indicate any third party software required and provide the software as part of the overall system. IL EPA requires that the selected vendor provide the control charting software (if not included in the LIMS application) and provide the integration of the software with the delivered LIMS.

The delivered LIMS should store MDL and IDC studies within the LIMS. It should require that an analyst have 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. The appropriate Supervisor and analysts should be notified of due dates within a lead-time configurable by authorized LIMS users.

The delivered LIMS should provide links to electronic documents that pertain to a test or method. These documents include, but are not limited to, QAP, SOP, Material Safety Data Sheet (MSDS), Personal Protective Equipment (PPE), and Chemical Hygiene Plan (CHP).

As part of IL EPA’s QA/QC protocol, they record and track Corrective Action Reports (CARs). The delivered LIMS should have the ability to electronically store a CAR and associate it to an individual analysis, batch or sample.

In conformance with the EPA, GALP and NELAP, the delivered LIMS shall maintain audit trails of all activities pertaining to analysts, sample identifiers and results.

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. IL EPA requires a process whereby the EDD that is fed to the Stripper program is “notified” when previously exported results or information have been changed. The new result(s) and associated audit trail information shall be passed through the EDD to the appropriate associated records in the Stripper program.

5.6. Report Generation

5.6.1. Current The IL EPA has many different submitting parties to send results data to and also have many different report formats for each party. Additionally, IL EPA generates reports that do not pertain to final results. These reports include, but are not limited to limit violations, exception reports, status and management reports, incident reports, and Corrective Action Reports (CARs).

The reports come from a variety of different sources that include, but are not limited to, output files from LIMS, Chemserver, and other third party software. Reports generated from LIMS are flat file, ASCII format. In addition to electronically generated reports, some reports are generated manually and are stored as hard copy. Manually generated reports include, but are not limited to, Incident and CAR reports.

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5.6.2. Required in New LIMS The IL EPA has specific reporting requirements that shall automatically be performed by the delivered LIMS. As a minimum, the delivered LIMS should support Excel, and Oracle Discover as programs for report generation.

The delivered LIMS shall come pre-configured with a minimum of six (6) management reports standard to most laboratory environments. These reports need not be customized to the client’s specifications but rather conform to the Vendor LIMS standard configuration of reports. Examples of management reports to be considered are:

• Work/sample backlog filterable by section, dept, or whatever representative sub-unit the client uses

• Total work/sample backlog listed for entire laboratory

• Lists of all Standards filterable by department, expiration, etc.

• Turnaround times for each part of analysis

• Sample Disposal List

• Statistical “counts” of samples (workload) filterable by designated time frames (month, quarter, year, etc.).

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

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.

Final as well as preliminary results shall be made accessible (with security) to the submitting parties via e-mail, Intranet, or Internet. The LIMS shall clearly distinguish preliminary results from final results. Electronic data deliverables of final and preliminary results should be available in a variety of final formats.

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. In the case where result data contains data qualifiers (defined by IL EPA), the report should include definitions of all qualifiers that were used. The delivered LIMS should store surrogate and internal standard data and should make the data available to be included on final reports. Forms shall be designed to be portrait or landscape oriented. 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. Release of final reports shall be contingent upon approval by authorized laboratory personnel.

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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).

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. The proposer shall provide examples of various report types (not specific to IL EPA) produced by the perspective LIMS. Examples shall include a final multi-test, multi-sample (e.g. Volatiles results plus metals) analytical report, a login receipt form, and a backlog list.

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.

The delivered LIMS shall have the ability to automatically generate routine reports on a scheduled basis. It shall allow IL EPA to designate the number and location of the reports that are to be printed, email, or faxed. 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.

Due to the limitations of the current LIMS system and data backup capabilities, IL EPA extracts the data from the LIMS and sends it on for microfilming. While the new LIMS will have the ability to store and maintain a greater amount of data, the IL EPA would still like to have the ability to generate and store electronic copies of the final reports. As such, the delivered LIMS should generate a "photocopy" of the final report in a format specified by IL EPA. Some acceptable formats could include, but are not limited to, bitmap, gif, jpeg, and pdf. The preferred format is pdf.

6. Laboratory Support The IL EPA maintains other functional areas in support of routine operations. The delivered LIMS shall include functionality (modules) capable of providing these same functions. Additionally, audit records shall be maintained and easily accessible for the purpose of meeting various certification requirements.

6.1. Standards and Reagents Most times, Primary or Stock Standards are received pre-mixed from vendors, while other times they are made by analysts using raw (neat) chemical constituents. Analysts record information such as lot number, constituents, expiration date, received by, received date, created by, created date, and concentration upon receipt or creation of various standards in a logbook. As standards are used to create secondary and working standards additional information is recorded such as dilution volumes, concentrations, expiration dates, creation date, analysts, etc. All of the chemical standards information should be maintained in the delivered LIMS. 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.

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In addition to supplies described in section 6.2, Pre-mixed Standards received from Vendors as well as pure chemical constituents used to create Stock Standards are to be considered inventory items by the LIMS. As such, the LIMS should provide for traceability from Inventory to Stock (Primary) Standards to Working (Secondary) Standards.

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

6.2. Chemical Inventory The delivered LIMS should maintain a Bar Coded inventory of all chemicals and supplies at each laboratory. Bar Code numbers shall be used to scan supplies in and out of inventory.

Initially, a pre-printed bar code label shall be applied to all received supplies. There should be a field provided in the LIMS Inventory module to scan this number into. The analyst can then populate information fields on the same screen for that item. The inventory information shall include item name, quantity, container type, supplier, lot number, expiration date, storage area, minimum on hand, and verification of receipt of the Material Safety Data Sheets (MSDS).

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. While in the inventory interface screen, scanning the Bar Code number shall bring up the records for that specific item.

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.

6.3. Instrument Maintenance Monitoring laboratory equipment is critical for maintaining data quality. The monitoring is conducted on a fixed schedule and some monitoring steps have specified acceptance criterion. This function shall be accomplished directly by the LIMS, as delivered, or by using an external program. The delivered LIMS should allow IL EPA personnel to schedule routine instrument maintenance and should notify designated personnel when maintenance is due.

6.4. GPS/GIS Currently, IL EPA and its Bureaus do not include GPS/GIS as part of their sample point definition. However, the delivered LIMS should allow for users to input GPS/GIS, Latitude and Longitude.

6.5. Safety Tracking safety and equipment checks is something that IL EPA does manually by going through a safety equipment checklist. IL EPA would like to be able to keep track of this in the delivered LIMS. The delivered LIMS should automatically schedule safety checks

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on a routine basis and should allow IL EPA to record information about the safety checks in the LIMS. The delivered LIMS should have the ability to download/upload information pertaining to the safety checks from/to a hand held PDA.

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.

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

6.6. Accounting The IL EPA would like to be able to track costs associated with sample analysis and be able to sort the costs by laboratory, submitting party, funding program, and analysis. IL EPA is contracting a third-party to provide them with a cost accounting system. 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.

The delivered LIMS should come pre-configured with invoicing functionality. The delivered LIMS shall associate a sample to the Funding Program from which it was sampled. 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.

6.7. Field Data Connectivity The BOW uses multi-parameter probes to capture field data from sample points in the field. Some of the multi-parameter probes have the ability to export data via an EDD while others do not.

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.

6.8. Scheduling Tool The IL EPA has the need to be able to schedule routine activities other than sampling events. 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. In addition to sample scheduling, it shall schedule safety inspections, equipment maintenance, MDL and IDC studies, routine reports, and employee safety and orientation training. Schedules should be capable of being set at different intervals. The schedule should be printable and capable of being faxed, e-mailed, etc.

7. Data Processing Environment Requirements The delivered LIMS shall operate within the data processing environment of IL EPA and other EPA Divisional entities.

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7.1. Server and Client Operating Systems The vendor shall install the LIMS server code (if needed) on a single server located in the IL EPA facility. All client machines used as System workstations will be configured using Novell on Microsoft Windows NT 4.0, 2000, or higher.

7.2. LIMS Data Storage 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. The IL EPA should be able to add additional tables to the delivered LIMS database without violating warranties or licensing agreements. The delivered LIMS shall be installed by the vendor and use the Oracle Database. The delivered LIMS shall allow multiple users to access the data simultaneously for data entry and retrieval without locking each other out. The vendor shall provide any necessary drivers for interaction between the user interface and the delivered LIMS database. The central database should be provided complete with tools for database management, archiving, and restoring from archive capabilities.

7.3. WAN / LAN The laboratory has computers that are linked in a Local Area Network (LAN). The IL EPA currently has a Novell network using Internet Packet Exchange / Sequential Packet Exchange (IPX/SPX) and TCP/IP.

7.4. Office Applications Laboratory workstations will use Microsoft Windows operating systems and Microsoft Suite office automation products. 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).

7.5. Data Backup and Storage IL EPA maintains its own backup and archive retrieval system. Databases are backed up with Oracle Corporation’s RMAN and Tivoli’s Storage Management (TSM)

7.6. Monthly Report File Procedure Currently, each lab creates a monthly report file, on disk, containing samples, which have been completed and transferred via EDD to our mainframe systems. This report file contains selected information about the sample itself and the results for each test that was conducted on it. An example of this file is attached as Appendix D. The resulting ASCII file is then transferred to another state agency and microfilmed for long term storage and eventual use in court if required. The delivered LIMS must be able to duplicate this procedure as well as storing the resulting ASCII file on retrievable write once media outside of the database architecture.

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7.7. Historical Data Currently, the IL EPA is exploring the use of Data Warehousing. The probable architecture will be Oracle on Sun hardware. The delivered LIMS should support migration of data from the active database to a data warehouse. The information in the data warehouse should be organized to facilitate retrieval of specific data. The IL EPA's preference is to use the LIMS front end to access this historical database.

8. Performance Requirements & New LIMS Submitted proposals shall discuss how the delivered LIMS will address the specific needs of the IL EPA facility that are outlined in this document, in addition to any other LIMS features that are proposed by the vendor. Omissions regarding features, performance, and/or functionality that are stated in the RFP or the LIMS Description of Services and not otherwise addressed will be considered the responsibility of the LIMS vendor.

8.1. Installation The vendor’s response shall include a pre-install owner checklist that covers hardware, software and staffing levels that the IL EPA must provide.

The selected LIMS vendor or their designated representative shall perform the initial installation of the LIMS including configuration, data conversion and customization tasks. Proposers shall provide, as part of their proposal, a path or sequence of events, including a timetable, for the completion of this effort. This discussion shall address the various worksheets, reporting formats, and other customized documentation required by the laboratory. If the installation process is separate from the LIMS software in the bid, a recommended path for completion of the installation process shall be included in any submitted proposal. The intent of IL EPA is to procure a functioning LIMS with known features that is operational by June 2003.

8.2. Training The proposer shall provide LIMS user training in two phases. Training shall be provided to System Administration users at the time of initial installation, and end user training shall be provided at the time of the final installation. The proposer shall include a detailed discussion of how LIMS training is to be addressed. The discussion shall include a list of course titles, course abstracts, and a description of the target audience.

8.3. Documentation 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.

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. This working copy of the delivered LIMS source code shall be placed in an escrow account (to be mutually agreed upon), in the event of vendor default or loss of vendor business

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viability. The vendor shall provide a list of recommended software for continued expansion of the LIMS.

8.4. Required New LIMS Completion Date Upon award and the subsequent issuance of a contract, the LIMS should be installed and fully functioning by June 2003. The proposer shall include a schedule, with measurable benchmarks, for the completion of the various tasks associated with this project.

8.5. Maintenance and Warranties

8.5.1. Maintenance Options The proposer shall include a discussion of any service contract options offered by the vendor for option comparison purposes.

8.5.2. Warranties/Guarantees The proposer shall include a discussion of any warranties or guarantees that are applicable to the offered products and services, which will be considered as part of the submittal evaluation process. IL EPA requires that the proposed LIMS shall be provided with a 12-month initial warranty from the date of final agency acceptance.

8.6. Instructions to Proposers Each vendor shall develop and deliver with their proposals a detailed project plan outlining the approach and proposed schedule for the project. The proposer shall also provide responses to each of the requirements contained in the table located in Appendix A. If the required function is fully provided as described, and does not require customization to your existing LIMS, (as of the date of the proposal deadline), respond “YES” in the provided column. If you believe that you substantially meet the requirement, or do so in a way that appears to be different than the descriptive statement, answer “YES/CLARIFY”, then explain the difference in the Comments block. If you do not provide the function but propose to provide it in a future release, or deliver it as a customization/enhancement, answer “ALTERNATE” and describe fully in the Comments block the scope of the customization/enhancement effort and a proposed release date. If you have an alternate proposal to a requirement, state the proposal, its reason, and propose an alternative solution. Answer “NO” if you will not provide a requirement. All requirements and sub-requirements must be answered. If the proposer does not address the requirement, a “does not comply” response will be assumed for evaluation purposes.

Keep in mind that Appendix A is a summary list of requirements. Context and detail for listed requirements can only be fully interpreted from the LIMS Description of Services itself. Proposers are to respond to, and are responsible for, line items in Appendix A and all associated requirements in the referred section.

Vendors should answer each requirement in the source selection matrix as fully as possible to enable the selection team to differentiate between various vendors’

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capabilities. Providing detail concerning how your product meets this requirement will enable the evaluation committee to best evaluate your product’s capabilities.

Unless otherwise stated, all of the requirements in Appendix A will be delivered 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. Should an identified functionality requirement be proposed as “not to be provided turn-key”, the vendor shall so state in the “Comments” section of Appendix A for the requirement. The vendor shall provide an estimate of the resources required for the IL EPA to develop the functionality or to have the unsupported work contracted to another vendor / integrator. The vendor will be responsible for supplying and installing upgrades and patches that are developed and promulgated during the warranty period.

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Appendix I - Acronyms A2LA American Association for Laboratory Accreditation ACES Agency Compliance and Enforcement System ASCII American Standard Code for Information Interchange BOA Bureau of Air BOL Bureau of Land BOW Bureau of Water CAA Clean Air Act CAR Corrective Action Report CERCLA Comprehensive Environmental Response, Compensation and Liability Act CD-R Compact Disk-Recordable CD-ROM Compact Disk-Read Only Memory CD-RW Compact Disk-Rewritable CHP Chemical Hygiene Plan COC Chain-of-Custody CWA Clean Water Act DDE Dynamic Data Exchange EDD Electronic Data Deliverables E-DMR Electronic Discharge Monitoring Report EPA Environmental Protection Agency FB Field Blank FTP File Transfer Protocol GALP Good Automated Laboratory Practices GPS/GIS Global Positioning Satellite/Geographical Information System ICEMAN Integrated Comprehensive Environmental Management System IDC Initial Demonstration of Competency IFRS Illinois Fluoridating Reporting System IL EPA Illinois Environmental Protection Agency IPX/SPX Internet Packet Exchange / Sequential Packet Exchange LAN Local Area Network LAS Laboratory Automation Solutions LCS Laboratory Control Sample LIMS Laboratory Information Management System MDL Method Detection Limit MSDS Material Safety Data Sheet MS/MSD Matrix Spike/Matrix Spike Duplicate NELAP National Environmental Laboratory Accreditation Program NPDES National Pollutant Discharge Elimination System OCS Office of Chemical Safety ODBC Open Data Base Connectivity OLE2 Object Linking and Embedding PDA Personal Digital Assistant PPE Personal Protective Equipment PWS Public Water Supply QA Quality Assurance

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Appendix I - Acronyms (continued) QAP Quality Assurance Plan QC Quality Control RB Reagent Blank RCRA Resources Conservation and Recovery Act RFP Request For Proposal SAFE Sample Analysis Facility Evaluation SDWA Safe Drinking Water Act SDWIS Safe Drinking Water Information System SOP Standard Operating Procedure STORET Storage Retrieval SWAP Source Water Assessment and Protection TCP/IP Transmission Control Protocol/Internet Protocol TSCA Toxic Substances Control Act TSM Tivoli Storage Management US EPA United States Environmental Protection Agency WAN Wide Area Network