1-LIMS RFP TNI2016 7 6 2026-Final (DNC)(8063872.1).pdf

Notice of Request for Proposals Laboratory Information Management System (LIMS)

Issued By:

Metropolitan Water District of Salt Lake & Sandy

3430 East Danish Rd Cottonwood Heights, UT 84093

RFP Number: [RFP-LIMS-2026-001]

Issue Date: July 6, 2026

Proposal Due Date: July 27, 2026 at 5:00 PM MST

Point of Contact: Josie Taber, Lab Supervisor

Contact Email: taber@mwdsls.gov

Contact Phone: 801-942-9651

NELAP Accreditation #: UT000172025-18

Accrediting Body: Utah Program

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Table of Contents Table of Contents

1. Introduction and Background

1.1 Purpose

1.2 Laboratory Overview

1.3 Accreditation Context

2. Procurement Process and Schedule

2.1 Key Dates

2.2 Submission Instructions

2.3 Questions and Clarifications

3.1 Deliverables

3.2 Deployment Model

4. Functional and Technical Requirements

4.1 Sample Receipt and Chain of Custody

4.2 Work Orders, Test Methods, and Analyte Management

4.3 Quality Control and QC Acceptance

4.4 Instrument and Equipment Management

4.5 Results Entry, Review, and Reporting

4.6 Data Integrity, Audit Trail, and Electronic Records

4.7 Personnel Qualifications and Training Records

4.8 Document Control and Standard Operating Procedures

4.9 Nonconformances, Corrective Actions, and Complaints

4.10 Subcontracted Work Management

4.11 Integration and Interoperability

5. Vendor Qualifications and References

5.1 Required Vendor Experience

5.2 Client References

6. Implementation, Training, and Support

6.1 Implementation Plan

6.2 System Validation

6.3 Training

6.4 Ongoing Support and Maintenance

7. Pricing Proposal Requirements

8. Proposal Evaluation and Award

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8.1 Evaluation Criteria

8.2 Evaluation Process

8.3 Demonstration Requirements

9. Contract Terms and Conditions Appendix A: Requirement Response Matrix Appendix B: TNI 2016 Standard Cross-Reference Appendix D: List of Accredited Methods Appendix E: List of Instruments & Software for Integration

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1. Introduction and Background

1.1 Purpose

Metropolitan Water District of Salt Lake & Sandy (Metro Water) is soliciting proposals from qualified vendors for the procurement, implementation, and ongoing support of a Laboratory Information Management System (LIMS) for its laboratory (the Laboratory). The selected LIMS must fully support the Laboratory's operational workflows and, critically, must enable compliance with the TNI Standard for Accreditation of Environmental Laboratories, 2016 Edition (TNI 2016 Standard) as required for our NELAC Institute (TNI) accreditation under the National Environmental Laboratory Accreditation Program

(NELAP).

This Request for Proposals (RFP) defines the functional, technical, and regulatory requirements that the proposed LIMS must satisfy. Vendors are expected to provide detailed responses demonstrating their system's capabilities, implementation approach, pricing, and ongoing support model.

Terms used but not otherwise defined in this RFP have the meanings assigned to them in the Glossary (Appendix C).

1.2 Laboratory Overview

The Laboratory is a NELAP-accredited environmental testing laboratory holding accreditation in the following matrices and analyte groups:

• Drinking Water (Safe Drinking Water Act matrices) The Laboratory processes approximately 3300 samples per month and employs 6 staff members. About 50% of the samples received are for microbiological testing.

1.3 Accreditation Context

The Laboratory holds accreditation under NELAP, administered by the state of Utah. Our accreditation requires full alignment with the TNI 2016 Standard, which consists of:

• Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis

• Volume 2: General Requirements: Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2005-based)

• Module 2: Quality Systems All LIMS functionality described in this RFP must be evaluated against these requirements. Mandatory requirements are non-negotiable; failure to meet any mandatory requirement will result in disqualification of the proposal.

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2. Procurement Process and Schedule

2.1 Key Dates

RFP Issue Date: July 07, 2026

Deadline for Written Questions: July 20, 2026 at 5:00 PM MST

Metro Water’s Response to Questions: July 22, 2026

Proposal Submission Deadline: July 27, 2026 at 5:00 PM MST

Vendor Demonstrations (if applicable): Week of August 03, 2026

Anticipated Award Notification: August 14, 2026

Board Approval of Procurement August 17, 2026

Target Contract Start Date: August 21, 2026

Target Go-Live Date: December 1, 2026

2.2 Submission Instructions

Proposals are to be submitted electronically via the Utah Public Procurement Place (U3P) website (https://utah.bonfirehub.com/portal/?tab=openOpportunities) no later than Monday, July 27, 2026 at 5:00 PM MST with the subject line: "LIMS RFP Response – [Vendor Name] – [RFP Number]." It is the Vendor’s responsibility to assure submission of the proposal. Late submissions will not be accepted (special or extenuating circumstances may permit a grace period as deemed reasonable by the Metro Water). Metro Water will be the sole judge as to which proposals best meet the selection criteria. Metro Water reserves, at its sole discretion, the right to reject any or all responses received, to waive any submission requirements contained within this RFP, or to waive any irregularities in any submitted response.

Submissions must include

1. Executive summary (maximum 2 pages)

2. Technical proposal addressing all requirements in section 4

3. Completed requirement response matrix (Appendix A)

4. Implementation plan and timeline

5. Vendor qualifications and references (minimum 3 NELAP laboratory references)

6. Pricing proposal

7. Sample contract and Service Level Agreements (SLA)

Metro Water reserves the right to request clarification of any item in a proposal or to request additional information necessary to properly evaluate proposals. All requests for clarification and responses will be via email.

https://utah.bonfirehub.com/portal/?tab=openOpportunities

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Metro Water’s RFP does not obligate the Metro Water to award any contract or to pay any costs incurred in the preparation of a proposal, interview, or associated materials.

Metro Water is subject to the Utah Government Records Access and Management Act, Title 63G, Chapter 2 of the Utah Code (GRAMA). If a vendor claims any portion of its proposal contains proprietary information, it is responsible for understanding and implementing any protection provided by GRAMA, including Section 63G-2-309, as that section may be amended. Metro Water will not be bound by any instructions or watermarks, stamps, or similar designations contained in a proposal, but rather, will only be governed by GRAMA and Metro Water’s GRAMA regulations. All materials become the property of Metro Water and may be returned at Metro Water’s option.

2.3 Questions and Clarifications

All questions must be submitted through the U3P website by July 20, 2026 at 5:00 PM MST. Vendor questions and answers will be distributed to all registered proposers via U3P website (https://utah.bonfirehub.com/portal/?tab=openOpportunities). No oral answers will be binding.

3. Scope of Work

3.1 Deliverables

The selected vendor shall deliver:

• Fully configured and tested LIMS installation (cloud-hosted / Software as a service (SaaS)

• Integration with Laboratory instruments and existing enterprise systems (see Appendix E)

• User acceptance testing (UAT) support and sign-off documentation

• Training for all staff categories (administrators, bench analysts, project managers, QA)

• System validation documentation suitable for NELAP accreditation audit review

• Ongoing technical support, maintenance, and software updates

3.2 Deployment Model

Describe the deployment model, including data residency, uptime SLAs, disaster recovery, and access during outages.

The preferred deployment would be SaaS.

For cloud-hosted systems, all data must reside on servers located within the United States and comply with applicable data security standards (see Section 4.6).

4. Functional and Technical Requirements Requirements are categorized by priority:

• Mandatory — System must fully support this capability; non-compliance disqualifies the proposal.

• High — Strongly preferred; absence must be explained and workaround proposed.

• Desirable — Adds value; vendors should describe capability or roadmap.

Proposals shall include a completed Requirement Response Matrix (Appendix A) that, for each requirement, indicates compliance level (Full Compliance / Partial Compliance (describe gap) / Not Supported) and provides explanatory notes where applicable.

https://utah.bonfirehub.com/portal/?tab=openOpportunities

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4.1 Sample Receipt and Chain of Custody

The LIMS must manage the complete sample lifecycle from login through final reporting. The following requirements directly support TNI 2016 Vol. 1 Section 5 (Technical Requirements) and Module 2 (Quality Systems).

Requirement TNI 2016 Reference Priority

Record sample receipt date, time, and receiving analyst

TNI 2016 Vol.1 §5.8.3 Mandatory

Capture and enforce holding times with automated alerts before expiration

TNI 2016 Vol.1 §5.8.3;

EL-V1M2 §4.11

Mandatory

Assign unique, non-repeating sample IDs with laboratory tracking numbers

TNI 2016 Vol.1 §5.8.2 Mandatory

Record sample condition upon receipt (e.g., temperature, intact seals, headspace)

TNI 2016 Vol.1 §5.8.3 Mandatory

Document rejection of non-conforming samples with reason code and notification

TNI 2016 Vol.1 §5.8.3 Mandatory

Support container and preservative tracking per method requirements

TNI 2016 Vol.1 §5.8.3 Mandatory

Maintain electronic Chain of Custody (COC) with e-signature capability

TNI 2016 Vol.1 §5.8 High

Support subsampling and aliquot tracking with parent-child relationships

TNI 2016 Vol.1 §5.8.2 High

Barcode / RFID scanning for sample login and tracking

TNI 2016 Vol.1 §5.8 High

Track client-submitted COC vs.

laboratory COC discrepancies

TNI 2016 Vol.1 §5.8.3 Desirable

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4.2 Work Orders, Test Methods, and Analyte Management

Requirement TNI 2016 Reference Priority

Associate specific EPA/ASTM/SM methods with each analyte and matrix.

See Appendix D

TNI 2016 Vol.1 §5.4.1 Mandatory

Restrict analysis to methods within the Laboratory's NELAP scope of accreditation

TNI 2016 Vol.1 §5.4.1;

NELAP policy

Mandatory

Track method revisions and enforce use of current approved version

TNI 2016 Vol.1 §5.4.4 Mandatory

Store method detection limits (MDL), practical quantitation limits (PQL), and reporting limits by method

TNI 2016 Vol.1 §5.4.6 Mandatory

Support method-specific QC requirements (blanks, spikes, duplicates, surrogates)

TNI 2016 Vol.1 §5.9 Mandatory

Manage client-specific reporting limits and turnaround time (TAT) requirements

TNI 2016 Vol.1 §5.10 High

Track subcontracted analysis with associated accreditation documentation

TNI 2016 Vol.1 §4.5 Mandatory

Flag results outside accredited scope or for out-of-scope methods

TNI 2016 Vol.1 §5.4.1 Mandatory

Support Client portal for logging in samples, sample status, and retrieving reports

High

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4.3 Quality Control and QC Acceptance

This section is critical to NELAP compliance. TNI 2016 Vol. 1 Section 5.9 establishes specific QC requirements that must be enforced by LIMS.

Requirement TNI 2016 Reference Priority

Automatically generate required QC samples (method blanks, LCS, MS/MSD, field blanks, duplicates) based on method and batch size

TNI 2016 Vol.1 §5.9.1 Mandatory

Track QC sample placement within analytical batches

TNI 2016 Vol.1 §5.9.1 Mandatory

Calculate and evaluate QC acceptance criteria (% recovery, RPD, control limits) against method-specific limits

TNI 2016 Vol.1 §5.9.1 Mandatory

Flag QC failures and link to associated samples, preventing result reporting until resolved

TNI 2016 Vol.1 §5.9.2 Mandatory

Document corrective action and re-analysis for QC failures with full audit trail

TNI 2016 Vol.1 §5.9.2;

EL-V1M2 §4.11

Mandatory

Generate and maintain control charts (X-bar, range, Shewhart) for ongoing QC monitoring

TNI 2016 Vol.1 §5.9.1 High

Support proficiency testing (PT) sample tracking, results entry, and PT provider data import

TNI 2016 Vol.1 §5.9.3;

NELAP policy

Mandatory

Track and report MDL study data and initial demonstration of capability

(IDOC/ODOC)

TNI 2016 Vol.1 §5.4.6 Mandatory

Support ongoing demonstration of capability (ODOC) tracking with expiration alerts

TNI 2016 Vol.1 §5.9.1 Mandatory

Enable matrix-specific QC requirements (drinking water)

TNI 2016 Vol.1 §5.9 Mandatory

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4.4 Instrument and Equipment Management

Requirement TNI 2016 Reference Priority

Maintain an inventory of all analytical instruments and equipment

TNI 2016 Vol.1 §5.5.1 Mandatory

Track instrument calibration schedules, calibration data, and calibration due dates with automated alerts

TNI 2016 Vol.1 §5.5.2 Mandatory

Store initial and continuing calibration verification (ICV/CCV) results with acceptance criteria

TNI 2016 Vol.1 §5.5.2 Mandatory

Link instrument calibration records to associated analytical results

TNI 2016 Vol.1 §5.5.2 Mandatory

Record instrument maintenance, service, and repair events

TNI 2016 Vol.1 §5.5.3 Mandatory

Flag results analyzed on instruments outside calibration or with failed calibrations

TNI 2016 Vol.1 §5.5.2 Mandatory

Support electronic data import from instruments (ASCII, CSV, EDD formats)

TNI 2016 Vol.1 §5.4.7 High

Track reference standards, reagents, and consumables with lot numbers and expiration dates

TNI 2016 Vol.1 §5.5.4 High

4.5 Results Entry, Review, and Reporting

Requirement TNI 2016 Reference Priority

Support multi-level results review workflow (analyst, supervisor, QA) with e-signature at each stage

TNI 2016 Vol.1 §5.10.2;

21 CFR Part 11

Mandatory

Apply and document all result qualifiers and data flags (e.g., J, B, E, HT, QC failure codes)

TNI 2016 Vol.1 §5.10.3 Mandatory

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Prevent reporting of unreviewed or unapproved results

TNI 2016 Vol.1 §5.10.2 Mandatory

Generate client reports in configurable formats (PDF, Excel, EDDs)

TNI 2016 Vol.1 §5.10 Mandatory

Support Electronic Data Deliverables (EDDs) for regulatory submittal (e.g., EPA EQuIS, WQX, state formats)

TNI 2016 Vol.1 §5.10 High

Automatically apply dilution factors, moisture corrections, and result calculations

TNI 2016 Vol.1 §5.4.7 Mandatory

Support client-specific report templates and regulatory compliance statements

TNI 2016 Vol.1 §5.10.2 High

Track and document sample-level narrative comments and report flags

TNI 2016 Vol.1 §5.10.3 Mandatory

Generate Certificate of Analysis (CoA) with required laboratory identification and accreditation statement

TNI 2016 Vol.1 §5.10.2;

NELAP

Mandatory

Maintain record of all issued and revised reports with reason for amendment

TNI 2016 Vol.1 §5.10.4 Mandatory

4.6 Data Integrity, Audit Trail, and Electronic Records

TNI 2016 and NELAP place significant emphasis on data integrity. The LIMS must maintain a complete and unalterable audit trail consistent with the principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).

Requirement TNI 2016 Reference Priority

Maintain a complete, tamper-evident audit trail of all data entries, edits, and deletions, capturing who, what, when, and reason for change

TNI 2016 EL-V1M2

§4.13; ALCOA+

Mandatory

Enforce role-based user access controls with unique user IDs and passwords

TNI 2016 EL-V1M2

§4.13

Mandatory

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Support 21 CFR Part 11 compliant electronic signatures for result approval

21 CFR Part 11; TNI 2016 §5.10.2

Mandatory

Restrict deletion of records; require supervisor authorization and documented reason

TNI 2016 EL-V1M2

§4.13

Mandatory

Provide immutable raw data storage;

original values preserved after edits

TNI 2016 EL-V1M2

§4.13; ALCOA+

Mandatory

Generate audit trail reports filterable by user, date range, sample, or data field

TNI 2016 EL-V1M2

§4.13

Mandatory

Support data retention policies aligned with regulatory requirements (minimum 5–10 years)

TNI 2016 EL-V1M2

§4.13

Mandatory

Encrypt data at rest and in transit (AES- 256 minimum for cloud deployments)

NIST SP 800-53; SOC

Mandatory

Provide SOC 2 Type II compliance documentation (for SaaS/cloud deployments)

SOC 2 Mandatory

Generate automated backups with tested recovery procedures and documented RTO/RPO

TNI 2016 EL-V1M2

4.7 Personnel Qualifications and Training Records

Maintain personnel qualification records (education, experience, training) per analyst

TNI 2016 Vol.1 §5.2 Mandatory

Track initial and ongoing competency demonstrations by method and matrix

TNI 2016 Vol.1 §5.2.2 Mandatory

Issue automated alerts for expiring analyst qualifications or training requirements

TNI 2016 Vol.1 §5.2 High

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Restrict sample analysis entry to analysts qualified for the applicable method and matrix

TNI 2016 Vol.1 §5.2 High

Record analyst assignments to each analytical result for traceability

TNI 2016 Vol.1 §5.2 Mandatory

4.8 Document Control and Standard Operating Procedures

Requirement TNI 2016 Reference Priority

Maintain a controlled document library for SOPs, methods, and forms with version control

TNI 2016 EL-V1M2

§4.3; Vol.1 §5.4.4

Mandatory

Enforce document approval workflow prior to release and track approval signatures

TNI 2016 EL-V1M2 §4.3 Mandatory

Prevent use of superseded document versions; automatically archive previous versions

TNI 2016 EL-V1M2 §4.3 Mandatory

Notify relevant staff of document updates and require acknowledgment

TNI 2016 EL-V1M2 §4.3 High

Link SOPs to associated methods, instruments, and analyte groups

TNI 2016 Vol.1 §5.4.4 High

4.9 Nonconformances, Corrective Actions, and Complaints

Record and track nonconformances including source, root cause, corrective action, and verification of effectiveness

TNI 2016 EL-V1M2

§4.9; §4.11

Mandatory

Link nonconformances to affected samples, results, QC batches, instruments, or personnel

TNI 2016 EL-V1M2

§4.11

Mandatory

Track corrective actions to closure with target dates and responsible party

TNI 2016 EL-V1M2

§4.11

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Maintain a complaint log with resolution documentation and client notification records

TNI 2016 EL-V1M2 §4.8 Mandatory

Support preventive action (PA) documentation separate from corrective action

TNI 2016 EL-V1M2

§4.12

High

Provide management review reports aggregating QC failures, NCs, and CAPAs

TNI 2016 EL-V1M2

§4.15

High

4.10 Subcontracted Work Management

Identify and flag samples or analyses sent to a subcontracted laboratory

TNI 2016 Vol.1 §4.5 Mandatory

Store and verify subcontractor NELAP accreditation scope documentation

TNI 2016 Vol.1 §4.5 Mandatory

Import and review results from subcontractors with associated QC and qualifiers

TNI 2016 Vol.1 §4.5 Mandatory

Disclose subcontracted results on client reports with subcontractor identification

TNI 2016 Vol.1 §4.5;

§5.10.2

4.11 Integration and Interoperability

Provide documented, open API (REST or SOAP) for third-party integration

IT best practice High

Support bidirectional instrument data import (See Appendix E)

TNI 2016 Vol.1 §5.4.7 High

Export data to EQuIS, EPA WQX, and state-specific EDD formats

Regulatory EDD requirements

High

Integrate with billing/ERP systems via standard data exchange

Operational requirement Desirable

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Support LIMS-to-LIMS data import for subcontractor result ingestion

TNI 2016 Vol.1 §4.5 Desirable

5. Vendor Qualifications and References

5.1 Required Vendor Experience

Vendors must demonstrate the following minimum qualifications:

• Minimum five years of experience implementing LIMS solutions in environmental testing laboratories

• At least three current client installations at NELAP-accredited laboratories using the proposed system

• Demonstrated experience with TNI 2016 Standard compliance documentation support

• U.S.-based technical support staff with environmental laboratory knowledge

5.2 Client References

Provide contact information for a minimum of three (3) NELAP-accredited laboratory references currently using the proposed LIMS version. References must be willing to be contacted by the Metro Water’s evaluation team. For each reference, provide:

• Laboratory name, location, and NELAP accreditation number

• Contact name, title, phone, and email

• Number of users, sample volume, and matrices analyzed

• Implementation date and current LIMS version

• Summary of any compliance-related customizations performed

6. Implementation, Training, and Support

6.1 Implementation Plan

Vendors must provide a detailed implementation plan including:

• Project plan with milestones, deliverables, and timelines from contract award through go-live

• Roles and responsibilities (vendor and Laboratory)

• Data migration strategy, including data mapping, validation, and acceptance testing protocol

• System configuration and customization approach for TNI/NELAP-specific workflows

• Risk register and mitigation strategies

• Go-live and parallel operation (parallel run) plan

• Post-go-live hyper care support plan

6.2 System Validation

The vendor must provide comprehensive validation documentation demonstrating LIMS fitness for purpose under NELAP audit requirements. This must include:

• Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation

• Validation test scripts and expected results

• Gap analysis against TNI 2016 Standard requirements

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• Ongoing validation support for system updates or configuration changes

6.3 Training

Propose a training plan covering:

• System administrator training (configuration, user management, backup/recovery)

• Bench analyst training (sample login, result entry, QC workflows)

• Project manager / client services training (work order management, reporting)

• QA manager training (QC review, audit trail review, nonconformance management)

• Train-the-trainer materials for future staff onboarding

• Access to online training portal or recorded sessions post-implementation

6.4 Ongoing Support and Maintenance

Describe your support model including:

• Help desk availability (hours, response time SLAs by severity level)

• Software update and version management policy

• Customer notification process for regulatory-driven updates (e.g. new TNI standard requirements)

• Account management and annual system review process

• User community / peer network access

7. Pricing Proposal Requirements Provide a total cost of ownership (TCO) breakdown including:

Software Licensing: Annual license or subscription fees (all modules required to meet this

RFP)

Implementation Fees: Project management, configuration, customization, data migration

Validation Documentation: IQ/OQ/PQ package preparation

Training: All training described in Section 6.3

Hardware (if applicable): Server, client hardware, barcode scanners, etc.

Integration Development: Instrument interfaces, EDD exports, API integrations

Annual Maintenance & Support:

Years 1–5 (itemized separately)

Optional Add-Ons: Describe and price separately (e.g., mobile apps, advanced analytics, customer portal)

Clearly identify any costs not included in the above that may be required to meet the full scope of this RFP. Price increases in Years 2–5 must be capped at no more than 3 – 5 % or CPI, whichever is lower.

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8. Proposal Evaluation and Award

8.1 Evaluation Criteria

Proposals will be evaluated by the LIMS Selection Committee using the following weighted criteria:

Evaluation Criterion Max Points Weight Vendor Score

Weighted Score

1. Functional and Technical Requirements

50 50%

2. Vendor Qualifications and References

20 20%

3. Implementation, Training, and Support

20 20%

4. Pricing / Total Cost of Ownership (5-yr)

10 10%

TOTAL 100 100%

Vendors scoring below 70% of available points in the Functional and Technical requirements category will not be considered further, regardless of total score.

8.2 Evaluation Process

1. Initial responsiveness review — all mandatory requirements must be marked full compliance

2. Scoring by Evaluation Committee using criteria above

3. Reference checks for top two to three vendors

4. Live system demonstration (virtual or on-site) by top two or three proposals — scored separately as set out below

5. Price proposal evaluation

6. Award recommendation and contract negotiation

8.3 Demonstration Requirements

Vendors invited to demonstrate must show live system functionality including:

• Sample login with holding time enforcement

• Analytical batch QC setup and automatic QC failure flagging

• Multi-level result review and electronic signature workflow

• Audit trail query and reporting

• Certificate of Analysis generation

• Control chart display for a QC parameter

• Nonconformance entry and corrective action tracking

• Instrument interfacing and automated data import (raw data capture, timestamps, traceability)

• Electronic record retention and retention period configuration

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• User roles/permissions matrix and configurable access controls (least privilege)

• Time-synchronized timestamps and time zone handling (immutable)

• System validation evidence and validation status tracking (IQ/OQ/PQ records)

• Method management (method versions, approvals, applicability to sample types)

• Sample chain-of-custody and tracking (sample receipt, custody transfers, hold/release)

• Batch/sample lineage (linking samples → analyses → results → QC)

• Calculation traceability and configurable calculation formulas with auditability

• Data review workflows with reviewer comments, sign-offs, and escalation rules

• Reporting templates and tamper-evident report generation (including metadata)

• Calibration management (calibration events, certificates, due/overdue alerts)

• LOD/LOQ and QC limit management and documentation

• Field/sample acceptance/rejection rules and automated holds for invalid samples

• Exportable audit trail and data in machine-readable format (CSV/XML)

• Electronic signature compliance (binding signatures, reasons, and timestamps)

• Data integrity controls (checksums, write-once audit logs, immutability)

• Training records and competency tracking linked to user accounts

• Security controls: encryption (at rest/in transit) and patch/update management

• Third-party/cloud hosting details and vendor responsibilities (data ownership)

• Capability to demonstrate corrective action verification and CAPA closure evidence

• Change control log and version history for configurations and system updates

• Configurable retention and purge policies with secure deletion workflows

• Inter-lab data exchange and proficiency testing result handling (if applicable)

Demonstration Evaluation Scoring

Each vendor demonstration will be scored by the Evaluation Committee using the criteria below. Scores reflect the quality and completeness of the live demonstration only. Rating scale: 0 = not demonstrated;

partial credit at evaluator discretion up to the maximum points shown. Demonstration scores will be added to the evaluation criteria scores.

Demonstration Criteria Max Points Score Notes

Audit Trail and Data Integrity (ALCOA+) 5

Calibration Management 5

Calibration Management Linked to Results 5

Certificate of Analysis Report Generation 5

CMDP / EDD Export 5

Control Chart Display for a QC Parameter 5

Corrective Action Workflows 5

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Data Review Workflows 5

Document Control Process 5

Employee Training Record 5

Exportable Audit Trail 5

Field/Sample Acceptance 5

Instrument Interfacing and Automated Data Importing

Inter-lab Data Exchange 5

Multi-Level Result Review and E-Signature Workflow

Nonconformance and Corrective Action Tracking

QC Batch Management and Failure Flagging 5

Record Retention 5

Sample Login and Holding Time Enforcement 5

User Roles and Access Controls 5

TOTAL 100

9. Contract Terms and Conditions Vendor shall supply a sample contract and SLA. Such contract and SLA (as applicable) shall contain the following provisions:

• Ownership of all data and configurations always remains with the Metro Water

• Vendor must provide data export in open, non-proprietary formats upon contract termination

• All data must be available for regulatory audit and legal discovery

• Vendor must notify Metro Water of any data breach within 24 hours of discovery

• Metro Water retains the right to audit vendor security practices annually

• A warranty period of at least 2 years

• If Vendor receives notice of a defect or non-conformance during the warranty period, Vendor will, at its option, repair or replace the affected Product, including labor, shipping and handling, LIMS RFP Page 20 of 29 training, and any other costs associated with repair or replacement. Vendor will pay expenses for return of such Product to Vendor and for shipment of the repaired or replacement Product.

• In the event the LIMS does not function as warranted and is not repaired or replaced within 21 business days after notice to Vendor, Vendor will reimburse Metro Water for reasonable costs of replacing the LIMS, including labor for removal and installation.

• Termination for convenience: 90-day notice by either party; termination for cause: immediate upon material breach

Metro Water shall be the sole determiner of the acceptability of any contracts or SLA. Please see Utah Code Section 63G-6a-1203 for provisions that are void and unenforceable and will not be accepted by Metro Water, and note certain provisions that are required by law to be included (see Utah Code §§ 63G- 12-302, 63G-27-201).

After the selection process is complete, Metro Water will either enter into the provided contract / SLA with the top-ranked vendor (if acceptable to Metro Water) or negotiate changes to the contract / SLA with the top-ranked vendor. If any such negotiations are not successful, Metro Water may award the contract to, or negotiate with, the second highest-ranked vendor.

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Appendix A: Requirement Response Matrix Complete this matrix for every requirement listed in Section 4. For each row, mark compliance level and provide explanatory notes where applicable.

Requirement Response Matrix Requirement TNI 2016 Reference Compliance Level (Full, Partial, Not Supported) Vendor Notes / Details

Record sample receipt date, time, and receiving analyst

TNI 2016 Vol.1 §5.8.3

Capture and enforce holding times with automated alerts before expiration

TNI 2016 Vol.1

§5.8.3; EL-V1M2

§4.11

Assign unique, non-repeating sample IDs with laboratory tracking numbers

TNI 2016 Vol.1 §5.8.2

Record sample condition upon receipt (e.g., temperature, intact seals, headspace)

TNI 2016 Vol.1 §5.8.3

Document rejection of non-conforming samples with reason code and notification

TNI 2016 Vol.1 §5.8.3

Support container and preservative tracking per method requirements

TNI 2016 Vol.1 §5.8.3

Maintain electronic Chain of Custody (COC) with e-signature capability

TNI 2016 Vol.1 §5.8

Support subsampling and aliquot tracking with parent-child relationships

TNI 2016 Vol.1 §5.8.2

Barcode / RFID scanning for sample login and tracking TNI 2016 Vol.1 §5.8 Track client-submitted COC vs.

laboratory COC discrepancies

TNI 2016 Vol.1 §5.8.3

Associate specific EPA/ASTM/SM methods with each analyte and matrix. See Appendix D

TNI 2016 Vol.1 §5.4.1

Restrict analysis to methods within the Laboratory's NELAP scope of accreditation

TNI 2016 Vol.1 §5.4.1; NELAP policy

Track method revisions and enforce use of current approved version

TNI 2016 Vol.1 §5.4.4

Store method detection limits (MDL), practical quantitation limits (PQL), and reporting limits by method

TNI 2016 Vol.1 §5.4.6

Support method-specific QC requirements (blanks, spikes, duplicates, surrogates)

TNI 2016 Vol.1 §5.9

LIMS RFP Page 22 of 29

Manage client-specific reporting limits and turnaround time (TAT)

TNI 2016 Vol.1 §5.10

Track subcontracted analysis with associated accreditation documentation

TNI 2016 Vol.1 §4.5

Flag results outside accredited scope or for out-of-scope methods

TNI 2016 Vol.1 §5.4.1

Support Client portal for logging in samples, sample status, and retrieving reports

Automatically generate required QC samples (method blanks, LCS, MS/MSD, field blanks, duplicates) based on method and batch size

§5.9.1

Track QC sample placement within analytical batches

TNI 2016 Vol.1 §5.9.1

Calculate and evaluate QC acceptance criteria (% recovery, RPD, control limits) against method-specific limits

§5.9.1

Flag QC failures and link to associated samples, preventing result reporting until resolved

TNI 2016 Vol.1 §5.9.2

Document corrective action and re-analysis for QC failures with full audit trail

TNI 2016 Vol.1

§5.9.2; EL-V1M2

§4.11

Generate and maintain control charts (X-bar, range, Shewhart) for ongoing QC monitoring

TNI 2016 Vol.1 §5.9.1

Support proficiency testing (PT) sample tracking, results entry, and PT provider data import

TNI 2016 Vol.1 §5.9.3; NELAP policy

Track and report MDL study data and initial demonstration of capability (IDOC/ODOC)

TNI 2016 Vol.1 §5.4.6

Support ongoing demonstration of capability (ODOC) tracking with expiration alerts

TNI 2016 Vol.1 §5.9.1

Enable matrix-specific QC requirements (drinking water) TNI 2016 Vol.1 §5.9 Maintain an inventory of all analytical instruments and equipment

TNI 2016 Vol.1 §5.5.1

Track instrument calibration schedules, calibration data, and calibration due dates with automated alerts

§5.5.2

Store initial and continuing calibration verification (ICV/CCV) results with acceptance criteria

§5.5.2

LIMS RFP Page 23 of 29

Link instrument calibration records to associated analytical results

TNI 2016 Vol.1 §5.5.2

Record instrument maintenance, service, and repair events

TNI 2016 Vol.1 §5.5.3

Flag results analyzed on instruments outside calibration or with failed calibrations

TNI 2016 Vol.1 §5.5.2

Support electronic data import from instruments (ASCII, CSV, EDD formats)

TNI 2016 Vol.1 §5.4.7

Track reference standards, reagents, and consumables with lot numbers and expiration dates

TNI 2016 Vol.1 §5.5.4

Support multi-level results review workflow (analyst, supervisor, QA) with e-signature at each stage

TNI 2016 Vol.1 §5.10.2; 21 CFR Part

Apply and document all result qualifiers and data flags (e.g., J, B, E, HT, QC failure codes)

TNI 2016 Vol.1 §5.10.3

Prevent reporting of unreviewed or unapproved results

TNI 2016 Vol.1 §5.10.2

Generate client reports in configurable formats (PDF, Excel, EDDs)

Support Electronic Data Deliverables (EDDs) for regulatory submittal (e.g., EPA EQuIS, WQX, state formats)

Automatically apply dilution factors, moisture corrections, and result calculations

TNI 2016 Vol.1 §5.4.7

Support client-specific report templates and regulatory compliance statements

TNI 2016 Vol.1 §5.10.2

Track and document sample-level narrative comments and report flags

TNI 2016 Vol.1 §5.10.3

Generate Certificate of Analysis (CoA) with required laboratory identification and accreditation statement

§5.10.2; NELAP

Maintain record of all issued and revised reports with reason for amendment

TNI 2016 Vol.1 §5.10.4

Maintain a complete, tamper-evident audit trail of all data entries, edits, and deletions, capturing who, what, when, and reason for change

TNI 2016 EL-V1M2

§4.13; ALCOA+

Enforce role-based user access controls with unique user IDs and passwords

LIMS RFP Page 24 of 29

Support 21 CFR Part 11 compliant electronic signatures for result approval

21 CFR Part 11; TNI 2016 §5.10.2

Restrict deletion of records; require supervisor authorization and documented reason

TNI 2016 EL-V1M2

§4.13

Provide immutable raw data storage; original values preserved after edits

TNI 2016 EL-V1M2

§4.13; ALCOA+

Generate audit trail reports filterable by user, date range, sample, or data field

TNI 2016 EL-V1M2

§4.13

Support data retention policies aligned with regulatory requirements (minimum 5–10 years)

Encrypt data at rest and in transit (AES-256 minimum for cloud deployments)

NIST SP 800-53;

SOC 2

Provide SOC 2 Type II compliance documentation (for SaaS/cloud deployments)

SOC 2

Generate automated backups with tested recovery procedures and documented RTO/RPO

TNI 2016 EL-V1M2

§4.13

Maintain personnel qualification records (education, experience, training) per analyst

TNI 2016 Vol.1 §5.2

Track initial and ongoing competency demonstrations by method and matrix

TNI 2016 Vol.1 §5.2.2

Issue automated alerts for expiring analyst qualifications or training

Restrict sample analysis entry to analysts qualified for the applicable method and matrix

Record analyst assignments to each analytical result for traceability TNI 2016 Vol.1 §5.2 Maintain a controlled document library for SOPs, methods, and forms with version control

TNI 2016 EL-V1M2

§4.3; Vol.1 §5.4.4

Enforce document approval workflow prior to release and track approval signatures

TNI 2016 EL-V1M2

§4.3

Prevent use of superseded document versions; automatically archive previous versions

TNI 2016 EL-V1M2

§4.3

Notify relevant staff of document updates and require acknowledgment

§4.3

LIMS RFP Page 25 of 29

Link SOPs to associated methods, instruments, and analyte groups

TNI 2016 Vol.1 §5.4.4

Record and track nonconformances including source, root cause, corrective action, and verification of effectiveness

§4.9; §4.11

Link nonconformances to affected samples, results, QC batches, instruments, or personnel

TNI 2016 EL-V1M2

§4.11

Track corrective actions to closure with target dates and responsible party

TNI 2016 EL-V1M2

§4.11

Maintain a complaint log with resolution documentation and client notification records

TNI 2016 EL-V1M2

§4.8

Support preventive action (PA) documentation separate from corrective action

TNI 2016 EL-V1M2

§4.12

Provide management review reports aggregating QC failures, NCs, and CAPAs

TNI 2016 EL-V1M2

§4.15

Identify and flag samples or analyses sent to a subcontracted laboratory

Store and verify subcontractor NELAP accreditation scope documentation

Import and review results from subcontractors with associated QC and qualifiers

Disclose subcontracted results on client reports with subcontractor identification

TNI 2016 Vol.1 §4.5;

§5.10.2

Provide documented, open API (REST or SOAP) for third-party integration

IT best practice

Support bidirectional instrument data import (See Appendix E)

TNI 2016 Vol.1 §5.4.7

Export data to EQuIS, EPA WQX, and state-specific EDD formats

Regulatory EDD requirements

Integrate with billing/ERP systems via standard data exchange

Operational requirement

Support LIMS-to-LIMS data import for subcontractor result ingestion TNI 2016 Vol.1 §4.5

LIMS RFP Page 26 of 29

Appendix B: TNI 2016 Standard Cross-Reference The table below maps major TNI 2016 Standard sections to corresponding LIMS functional areas addressed in this RFP.

TNI 2016 Section Topic RFP Section(s)

Vol.1 §5.2 Personnel Competence and Qualifications

Section 4.7 of this RFP

Vol.1 §5.4.1 Method Selection and Verification Section 4.2 of this RFP

Vol.1 §5.4.4 Method Documentation and SOPs Section 4.8 of this RFP

Vol.1 §5.4.6 MDL / Reporting Limits Section 4.2 of this RFP

Vol.1 §5.4.7 Data Integrity / Instrument Data Section 4.4, 4.6 of this RFP

Vol.1 §5.5 Equipment and Calibration Section 4.4 of this RFP

Vol.1 §5.8 Sampling and Sample Management

Section 4.1 of this RFP

Vol.1 §5.9 Quality Control Section 4.3 of this RFP

Vol.1 §5.10 Reporting of Results Section 4.5 of this RFP

Vol.1 §4.5 Subcontracted Work Section 4.10 of this RFP

EL-V1M2 §4.3 Document Control Section 4.8 of this RFP

EL-V1M2 §4.8 Complaints Section 4.9 of this RFP

EL-V1M2 §4.9 Control of Nonconforming Work Section 4.9 of this RFP

EL-V1M2 §4.11 Corrective Action Section 4.9 of this RFP

EL-V1M2 §4.12 Preventive Action Section 4.9 of this RFP

EL-V1M2 §4.13 Control of Records Section 4.6 of this RFP

EL-V1M2 §4.15 Management Reviews Section 4.9 of this RFP

LIMS RFP Page 27 of 29

Appendix C: Glossary

ALCOA+ Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available — data integrity framework

CAPA Corrective Action / Preventive Action

CoA Certificate of Analysis

CCV Continuing Calibration Verification

EDD Electronic Data Deliverable

IDOC/ODOC Initial Demonstration of Capability / Ongoing Demonstration of capability

IQ/OQ/PQ Installation / Operational / Performance Qualification

LCS/LCSD Laboratory Control Sample / Laboratory Control Sample Duplicate

MDL Method Detection Limit

MS/MSD Matrix Spike / Matrix Spike Duplicate

NELAP National Environmental Laboratory Accreditation Program

NELAC National Environmental Laboratory Accreditation Conference (former name of TNI)

PQL Practical Quantitation Limit

RPD Relative Percent Difference

SaaS Software as a Service

SLA Service Level Agreement

SOP Standard Operating Procedure

TCO Total Cost of Ownership

TNI The NELAC Institute

TNI 2016 TNI Standard for Accreditation of Environmental Laboratories, 2016 Edition

UAT User Acceptance Testing

LIMS RFP Page 28 of 29

Appendix D: List of Accredited Methods

SM 2540 D – Total Suspended Solids Clean Water Act

SM 4500-H+ B - pH Safe Drinking Water Act

SM3500-Ca B – Calcium Hardness Safe Drinking Water Act

SM 9215 E - Simplate Safe Drinking Water Act

SM 9223 – Colilert & Quantitray Safe Drinking Water Act

SM 2130 B - Turbidity Safe Drinking Water Act

SM 2150 B - Odor Safe Drinking Water Act

SM 2320 B – Alkalinity as CaCO3 Safe Drinking Water Act

SM 2340 C – Total Hardness Safe Drinking Water Act

SM 2510 B - Conductivity Safe Drinking Water Act

SM 2540 C – Total Dissolved Solids Safe Drinking Water Act

SM 4500-Cl G – Residual Chlorine Safe Drinking Water Act

SM 5310 B – High Combustion TOC/DOC Safe Drinking Water Act

SM 5910 B – UV 254 Safe Drinking Water Act

EPA 200.8 – Metals By ICP MS Safe Drinking Water Act

EPA 300.0 - Safe Drinking Water Act

EPA 300.1 – Bromate, Bromide Safe Drinking Water Act

EPA 524.2 – THM’s Safe Drinking Water Act

EPA 552.2 – HAA’s Safe Drinking Water Act

LIMS RFP Page 29 of 29

Appendix E: List of Instruments & Software for Integration

Manufacturer Instrument Software

Metrohm

800 Dosino Tiamo Version 2.4 Build 109

Agilent GC-7890A, MSD-5975C, Purge & Trap, Autosampler

MSD Chemstation Version E.02.00.493

Thermo Fisher Scientific

GC, Trace 1300 Chromeleon, Version 7.2.8

Shimadzu TOC-L CPH TOC-Control L Ver 1.09

Theroscientific Ion Chromatograph Chromeleon, Version 7.2.8

Agilent ICP MS 7850 Mass Hunter Software 5.2

Shimadzu UV-1800

UV Probe

HACH TU5200 Turbidimeter

End of Request for Proposal