Att- K SOW (Toxicology).docx

STATEMENT OF WORK

I. EXECUTIVE SUMMARY

The Contractor will deliver comprehensive toxicology/forensic toxicology testing services to support The State of Indiana. It is the intent to contract with one or more respondents who provide quality toxicology testing services on behalf of the State of Indiana and Indiana’s 92 county coroners. The Contractor shall accept all specimens submitted including during surge events and the Contractor must demonstrate capacity to manage anticipated volumes based on historical data, including 307–539 total monthly specimens (245–411 blood, 20–51 urine, 34–82 vitreous) and a minimum of 100 Indiana State Department of Toxicology (ISDT) samples. The services for The State of Indiana include the analysis of biological specimens for alcohol, drugs, and other toxic substances; the issuance of detailed analytical reports; secure management of evidence and chain-of-custody documentation; and adherence to strict quality, accreditation, and regulatory standards. The respondents will provide timely turnaround on results, maintain secure handling and storage of data and records, and offer expert consultation or testimony when required. Additional responsibilities include ongoing communication, performance reporting, compliance with quality assurance programs, and full participation in transition and turnover activities at the end of the contract term.

II. BACKGROUND AND CURRENT STATE

The Indiana State Department of Toxicology requires reliable forensic toxicology analysis to support casework involving impaired driving and postmortem cases. Current testing capacity is limited; therefore, The Indiana State Department of Toxicology needs to outsource toxicology testing to an International Organization of Standardization (ISO) 17025 accredited laboratory.

The Indiana Department of Health (IDOH) is responsible for creating and maintaining a statewide toxicology testing program for coroners to use, free of charge. Indiana Code 4‑23‑6.5‑11 requires: The state department of health shall contract with a third party for testing services under this chapter. The respondent will be awarded a contract with the goal and obligation to have the capacity to provide statewide toxicology testing services for all of Indiana’s 92 county coroners.

III. SCOPE OF WORK

The Contractor shall accept blood, urine, and vitreous matrices; perform screening, confirmation, and directed confirmation testing for the State-approved analyte list; provide secure web portal access for results; furnish certified documents and expert testimony upon request; supply statewide specimen collection and shipping materials; and comply with chain-of-custody, confidentiality, and accreditation requirements.

a. OBJECTIVES OF ENGAGEMENT

a. Maintaining accurate chain of custody documentation.

b. Providing certified documents to prosecutors upon request.

c. Providing expert testimony upon request.

d. Portal Uptime: Achieve portal uptime ≥ 99.5% monthly; respond to helpdesk tickets within 1 business day; meet turnaround time SLA targets defined herein; maintain accreditation status notices within 5 business days of any change.

b. DELIVERABLES AND DEADLINES

The respondents shall perform toxicology analysis on all specimens submitted by the State of Indiana and a measurable SLA incorporating percentile targets (e.g., 95% of specimens within 10 business days, with a maximum of 15 business days, except for defined holiday exceptions). Measurement uncertainty shall be reported as expanded uncertainty with coverage factors and shall meet method validation requirements. The Contractor shall demonstrate compliance with required limits of detection (LOD) for all analytes in the State list. The respondents shall provide all necessary statewide shipping supplies and shall retain all specimens for a minimum of twelve (12) months after testing completion and return specimens only upon written request from the State or county coroner.

When results are to be sent to a county coroner’s office, the results shall be posted to a secure website accessible only to the authorized staff of the submitting county coroner’s office and the Indiana Department of Health (IDOH). Toxicology results are protected information, and disclosure beyond these parties would violate confidentiality laws. Respondents must strictly maintain confidentiality and shall not release information or documentation to any other party.

Only the county coroner may release any information regarding the means and manner of a person’s death. The county coroner has the authority to request expert testimony from the vendor. However, a subpoena issued by any other party cannot compel the vendor to discuss specific cases. Certified document requests and any responses to subpoenas must be handled by the county coroner’s office and IDOH in accordance with confidentiality laws and established program procedures.

For ISDT cases, if a county prosecutor contacts the contractor directly to request certified documents or expert testimony, the contractor must notify ISDT. ISDT will determine whether the services are authorized and will provide directions on the release of information and billing. Comment by Kandola, Simran: For ISDT, we need all toxicology reports to be issued to ISDT only. We then take the report and attach it to our ISDT toxicology report which includes other testing results, so we don’t need/want our end customers (prosecutors) to get the contractor reports directly from the contract lab.

The respondents shall provide a monthly spreadsheet of all positive findings and maintain strict confidentiality of all case information.

Specific requirements for other State agencies will be detailed in a sub-agreement if necessary.

c. PAYMENT MILESTONES

Monthly invoices shall be submitted for toxicology testing performed. Each invoice must include a detailed breakdown of testing totals, listing blood, urine, and vitreous separately. For each specimen type, the respondent shall report both the total dollar amount billed and the number of samples tested during the billing period. In addition, ISDT requires that all invoices be itemized at the individual-sample level, including the specific case number associated with each specimen. Invoices shall be submitted via a secure portal and exclude any personal identifiers to minimize exposure of protected health information (PHI).

All test results produced under this contract are confidential because each specimen is associated with a specific decedent and can be viewed only by the submitted agency. This testing program exists solely to support county coroner death investigations. Only the county coroner has the authority to release information regarding the means and manner of death, and while the coroner may request expert testimony from the vendor. Upon receipt of any subpoena or request for records, the Contractor shall notify IDOH and the submitting county coroner within one (1) business day and respond only as directed by the State. No disclosure shall occur without written State authorization, except as required by law.

IV. PROJECT MANAGEMENT

a. PROJECT MANAGEMENT PLAN

The contractor will collaborate with the agencies to ensure alignment of expectations and operational needs.

The respondents, prior to implementing the new contract, must create a communication plan to inform State agencies and county coroners about project information, implementation and/or transition, if applicable. The Communication Plan should account for all stakeholders involved in the project, including the State of Indiana, other related State contractors, the respondents and its subcontractors, authorized vendors or providers, and local and Federal partners as applicable. The Communications Plan shall detail how communications among and between stakeholders will be delivered and managed. At a minimum, it must include the following:

· Background on their organization.

· How the respondent is going to implement the contract.

· What coroners can expect from the organization.

· What supplies do they provide and when will they be delivered to the coroners.

· What and when certain milestones will be met.

· Their statutory reporting requirements can be met by submitting their toxicology samples to your laboratory.

· Who will have access to their data and how it will be shared.

· Communication protocols and procedures for reporting project issues to State stakeholders.

· Escalation contacts and process

b. KEY PERSONS Comment by Kandola, Simran: Need specific people

a. Dr. Christina Beymer, Director, Indiana State Department of Toxicology, cbeymer@isdt.in.gov

b. Murray Lawry, Indiana Department of Health Manager, Mlawry@health.in.gov

c. Simran Kandola, Indiana Department of Administration, Procurement Specialist, simkandola@idoa.in.gov

Respondents must identify key vendor roles including Program Manager, Quality Director, IT Security Lead, and Lead Toxicologist. Each role should specify responsibilities, minimum qualifications, and expected availability. Any substitution requires prior written State approval. The State may request replacements and interview candidates.

c. DOCUMENT MANAGEMENT

Project documents will be managed, stored, and accessed via the submission materials provided by county coroners, who currently submit samples in vendor‑supplied transport containers along with a one‑page order sheet containing checked boxes and coroner comments. All documents must be submitted in editable and PDF formats, use State-approved naming conventions, and maintain version control with an audit trail. Access permissions will be managed by the State to ensure confidentiality and compliance with applicable security and privacy standards. All toxicology test results must be stored on the vendor’s secure website and segregated by county to ensure proper data management and controlled access.

a. The respondents shall implement secure document management:

i. Maintaining complete chain of custody documentation for all specimens

ii. Storing analytical data and reports in a secure and confidential manner

iii. Providing the agencies and prosecutors with access to records upon request

iv. Ensuring all report delivery and email communications are secure

d. STATUS UPDATES AND REPORTING

a. The respondents shall provide the agencies with a monthly spreadsheet of all positive toxicology findings.

b. The respondents shall immediately notify the agencies of any issues affecting sample integrity, delays, or quality concerns.

c. Governance will include monthly operations reviews and quarterly steering committee meetings. Communication recipients for ad-hoc communications shall be specified.

d. The respondents shall immediately notify the agencies of any loss of accreditation.

e. The respondents shall notify and seek approval from the agencies prior to providing prosecutors with records that will incur a charge.

V. TRANSITION PLAN

In the event of a transition, the respondents shall work with The State of Indiana to develop and manage plans for transferring services from the current incumbent vendor over a period not to exceed 60 calendar days. The Transition Plan shall include a cutover checklist, rollback plan, test scripts, migration validation, and governance (monthly operations review, quarterly steering committee). The respondents must prepare a Transition Plan detailing that includes its assumption of the work detailed in this scope. The draft Transition Plan must include detailed steps and procedures necessary to prepare for, transition, and provide all services required for the program in this RFP with minimal no disruption to clients, vendors/providers, State users, and other stakeholders. This Plan must include details on how the respondent plans to interface with the incumbent vendor to transfer responsibilities during the transition. The plan must provide a detailed timeline for coordination and completion of the transition:

· A description of the overall approach.

· The order in which transition activities will occur.

· Tasks to be performed.

· Parties responsible for the completion of each task.

· A backup plan if any or all of the transition activities are delayed.

· Training.

· Customer service.

· Timeframe for database conversion, including a backup date.

· Testing procedures, verification, and validation of the migration process.

· Quality assurance checkpoints and critical paths.

VI. COMPLIANCE REQUIREMENTS

At a minimum, the respondents must meet the following requirements:

Accreditation and Standards

· Maintain current accreditation to the International Organization of Standardization (ISO) 17025 or an equivalent recognized forensic laboratory standard.

· Adhere to scientific best practices established by professional organizations such as the Society of Forensic Toxicologists (SOFT) and the American Academy of Forensic Sciences (AAFS), where applicable.

· Maintain validated analytical methods and documented technical procedures consistent with accreditation requirements.

· Maintain accreditation under the American Board of Forensic Technology (ABFT), Clinical Laboratory Improvement Amendments (CLIA), and/or Drug Enforcement.

· Maintain accreditation under the International Organization of Standardization (ISO) and shall notify IDOH within five (5) business days of any change in this accreditation status.

· Must maintain national accreditation from College of American Pathologists (CAP).

Legal and Regulatory Compliance

· Comply with all Indiana Codes applicable laws related to forensic testing, including requirements governing controlled substances, impaired driving investigations, and toxicological evidence.

· Follow all chain‑of‑custody standards necessary to preserve the integrity and admissibility of evidence in judicial proceedings. All test results are provided to the county coroner in the county where the death occurred and are used by the coroner to determine the means and manner of death for the death certificate. The toxicology respondents may provide testimony only regarding its testing methods and analytical procedures for specific drugs; the vendor cannot disclose the name, county, or any identifying information of a decedent under any circumstances.

· Ensure compliance with privacy and confidentiality regulations pertaining to medical and personal information.

· Provide testing services to all 92 county coroners and their staff.

· Offer free shipping of samples from all 92 county coroner offices.

Quality Assurance and Quality Control

· Implement and maintain a comprehensive Quality Assurance Program that includes internal audits, external proficiency testing, instrument calibration, and method verification.

· Participate in recognized forensic toxicology proficiency testing programs as required by accreditation standards.

· Participate in recognized forensic toxicology proficiency testing (minimum twice per year) and maintain records of performance and corrective actions.

· Promptly notify the Agency of any significant quality incidents, including instrument failures, sample contamination, or findings affecting result integrity.

Data Security/Access and Record Management

The State has robust and comprehensive security standards that permeate all levels of the organization. The Indiana Office of Technology (IOT) has been tasked with establishing and maintaining these security standards. The security standards include assessing security risks, developing, and implementing effective security procedures, and monitoring the effectiveness of those procedures. If the proposed solution involves information technology-related products or services, all such products or services are to be compatible with any of the technology standards found in the Statewide IT Policies, Procedures, & Standards (https://www.in.gov/iot/policies-procedures-and-standards/) that are applicable, including the assistive technology standard. The Contractor will be required to sign a Non-Disclosure Agreement (NDA) to access the more sensitive standards and policies. The Contractor should review the Statewide IT Policies, Procedures, & Standards and ensure their proposed solution meets all standards therein.

Additional Requirements Include:

· Maintain secure systems for data storage, transmission, and retrieval.

· Protect all digital and physical records from unauthorized access, alteration, or disclosure.

· Ensure retention of records for the duration required by accreditation standards or statutory mandates.

· Provide electronic access to test results for all samples submitted by county coroners through the vendor’s website or another agreed‑upon platform applicable to agency IT approval.

· Work with the agencies to create a suitable electronic pathway that supports test result access and analysis.

· Maintain an average turnaround time of 10 business days or less from receipt of sample to completed results and posting in the online database.

Personnel and Training

· Ensure all laboratory personnel assigned to this contract meet professional qualifications consistent with forensic toxicology practice and accreditation standards.

· Maintain ongoing training, competency assessments, and continuing education for staff.

· Notify the agencies of any changes in qualifications or certifications that may affect contract performance.

· Provide training to all county coroners and their staff.

· Statewide training shall be provided quarterly via virtual sessions and annually via in-person workshops, covering specimen collection, chain of custody, and portal use. All laboratory personnel must hold relevant professional certifications.

· Make available, at no additional cost, a PhD-level board‑certified toxicologist for questions or training.

· Be reachable by email, phone, or text to support coroners and their staff at no charge.

Audit and Review Rights

· Permit the agencies representatives to conduct reasonable audits or inspections of facilities, processes, and documentation relevant to contract compliance.

· Cooperate fully with the agency’s reviews, inquiries, or investigations related to casework, quality concerns, or accreditation.

Specimen Collection Supplies & Services

· Mailers with preprinted return labels

· Tubes, bottles, syringes

· Specimen transport bags

· Evidence seals

· Transport boxes

· Preprinted requisitions with the agencies billing details

· Cover shipping costs.

· Provide documented forensic chain of custody.

· Provide laboratory analysis, formal written reports, interpretation, and consultation.

· Maintain specimens for at least 12 months, with extended storage available upon request.

· Maintain records for a minimum of seven years or according to accreditation requirements.

Sample Handling and Testing Capabilities

· Accept and test blood, urine, and vitreous samples.

· Test samples for all drugs on the agencies list, currently requiring verifiable testing for 366 compounds.

· The full analyte list is attached as Appendix A. State approval is required for any additions or removals, with 30-day notification and validation documentation.

· Maintain the ability to add or delete drugs from the routine testing list as needed to stay current with emerging substances.

· Request the State of Indiana for when new drugs are required or existing ones are needing to be removed.

VII. KEY PERFORMANCE INDICATORS

The State will use Key Performance Indicators (KPIs) to measure performance and outcomes of the Contract. The specific KPIs and their targets will be defined and agreed upon by the State and the Contractor during the initial phases of the requirements under the Contract. At a minimum, on time delivery at quality standards of the scope provided within the budget set forth in the Contract will each be measured. Additionally, the State will collect a modified Net Promoter Score from customers to this Contract in its discretion. Low ratings on the modified Net Promoter Score or failure to meet any other KPIs may be deemed, at the discretion of the State, to constitute default under the Contract.

Failure to meet KPI targets will trigger corrective action plans. Repeated failures may constitute default and permit termination or other remedies per Contract

VIII. END OF CONTRACT TRANSITION AND TURNOVER

The Contractor shall develop a turnover plan within three months of Contract execution, detailing activities for transferring responsibilities, non-proprietary components, data, and operational documentation to the State or its agent. The turnover plan shall be mutually maintained throughout the term of the Contract. The Contractor shall maintain mutually agreed upon staffing levels during turnover and commence training and shadowing (must be available during the length of contract to meet the ten working days turnaround) prior to contract end for staff who will assume operations. The State will approve the designated Turnover Manager. The Contractor shall provide a knowledge transfer checklist (contacts, training materials) and deliver a data disposition certificate confirming deletion or return of State data within three months after contract completion unless otherwise agreed.