FINAL Statement of Work (SOW) FBI Lab Chemistry Unit.pdf

Toxicological Testing

For the

Chemistry Unit, Laboratory Division

Statement of Work

4/29/2024

(Insert contract number or language such as “Task Order issued against MOBIS or PMSS or ITSSS contract number xxx” if SOW is for a Task Order)

1 Scope

This is a firm fixed price stand-alone contract to provide toxicological testing services to the

Federal Bureau of Investigation (FBI) Laboratory Division (LD), Chemistry Unit (CU). This is a non-personal services contract. The Government shall not exercise any supervision or control over contractor employees performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction

The CU requires a laboratory to perform toxicology testing on samples of human blood, urine, vitreous humor, and tissue samples. This will include both qualitative and quantitative testing for the presence of substances including various drugs of abuse, prescription medications, volatiles, alcohol, and poisons. Estimates of the number of cases to be submitted have been included in section 3.1 below along with the most common tests to be requested by the CU.

1.2 Background

The FBI Laboratory receives antemortem and postmortem toxicology samples requiring testing in FBI investigations, as well as related to criminal investigations underway at other federal agencies and occasionally in state and local investigations. Additionally, the FBI Laboratory receives postmortem samples in routine death investigations from certain tribal agencies. In an effort to focus resources on research, development, and other needs, the FBI Laboratory is planning to outsource a portion of this toxicology casework. This work is currently being procured via Government Purchase Card (GPC), but due to spending levels and administrative burden, there is a need for a longstanding contract.

2 Applicable Documents

International Organization for Standardization ISO/IEC 17025 - General Requirements for the

Competence of Testing and Calibration Laboratories

ANSI National Accreditation Board ANAB AR 3125 Accreditation Requirements for Forensic

Testing and Calibration (2023)

American Board of Forensic Toxicology (ABFT) Laboratory Accreditation Checklist (supplemental to ISO 17025)

ANSI/ASB Standard 119 - Standard for the Analytical Scope and Sensitivity of Forensic

Toxicological Testing of Blood in Medicolegal Death Investigations

ANSI/ASB Standard 120 - Standard for the Analytical Scope and Sensitivity of Forensic

Toxicological Testing of Blood in Impaired Driving Investigations

ANSI/ASB Standard 121 – Standard for the Analytical Scope and Sensitivity of Forensic

Toxicological Testing of Urine in Drug-Facilitated Crime Investigations

3 Requirements

The laboratory performing the required testing must be accredited to International

Organization for Standardization (ISO) 17025: 2017 General requirements for the competence of testing and calibration laboratories to include supplemental requirements found in ANAB AR

3125 Accreditation Requirements for Forensic Testing and Calibration (2023). Additionally, it is required that the laboratory will also be accredited to the American Board of Forensic

Toxicology (ABFT) standards/checklist. The laboratory’s scope of testing under accreditation must include:

1. Quantitative and qualitative volatiles testing for postmortem specimens (blood and vitreous humor) and antemortem specimens (blood and urine)

2. Qualitative and quantitative toxicology testing for antemortem and postmortem blood specimens

3. Qualitative toxicology testing for antemortem urine specimens.

3.1 Required Testing

The following tests shall be performed, as specified by the CU for each sample. In addition to the below listed tests, other tests may be requested on an ad hoc basis, including but not limited to quantitative testing of blood for specific drugs of abuse, prescriptions medications, and over the counter drugs.

Postmortem Testing for volatiles and drugs of abuse in blood samples (estimated 75-125 samples per year, not to exceed 150 samples per year):

1. Volatiles testing of blood for ethanol, methanol, acetone and isopropanol (IPA) with quantitative reporting for concentrations above 0.01 g/dL (acetone and IPA) and above

0.02 g/dL (methanol and ethanol). Measurement Uncertainty (MU) must be reported with positive results.

2. Drug and metabolite testing of blood samples for common drugs of abuse to include benzodiazepines, cannabinoids, cocaine/metabolites, opioids and sympathomimetic amines. Positive results must be reported quantitatively. Measurement Uncertainty

(MU) must be reported with positive results. Specific analytes and sensitivity of methods should meet requirements set forth in ANSI/ASB Standard 119, Table 2.

Postmortem Testing for volatiles in vitreous humor samples (estimated 50-100 samples per year, not to exceed 150 samples per year). Vitreous samples will only be submitted with a paired blood sample:

1. Volatiles testing of blood and vitreous samples for ethanol, methanol, acetone and isopropanol (IPA) with quantitative reporting for concentrations above 0.01 g/dL

(acetone and IPA) and above 0.02 g/dL (methanol and ethanol). Measurement

Uncertainty (MU) must be reported with positive results.

Postmortem Testing for volatiles, drugs of abuse, prescription medications, and over the counter medications in blood samples (estimated 5-15 samples per year, not to exceed 25 samples per year):

1. Volatiles testing of blood for ethanol, methanol, acetone and isopropanol (IPA) with quantitative reporting for concentrations above 0.01 g/dL (acetone and IPA) and above

0.02 g/dL (methanol and ethanol). Measurement Uncertainty (MU) must be reported with positive results.

2. Drug and metabolite testing of blood samples for drug classes to include anticonvulsants, antidepressants, antihistamines/antitussives, antipsychotics, barbiturates, benzodiazepines, cannabinoids, cocaine/metabolites, dissociatives, muscle relaxants, opioids and sympathomimetic amines. Positive results must be reported quantitatively. Measurement Uncertainty (MU) must be reported with positive results.

Specific analytes and sensitivity of methods should meet requirements set forth in

ANSI/ASB Standard 119, Table 1.

Additional testing of postmortem blood samples (estimated 0-10 samples per year, not to exceed 15 samples per year):

1. Acetaminophen, salicylates and/or carbon monoxide testing with quantitative results.

Measurement Uncertainty (MU) must be reported with positive results. Specific analytes and sensitivity of methods should meet requirements set forth in ANSI/ASB

Standard 119, Table 1.

Human Performance Testing for driving under the influence of drugs (DUID) in blood samples

(estimated 15-25 samples per year, not to exceed 35 samples per year):

1. Ethanol testing with quantitative reporting for concentrations above 0.01 g/dL.

Measurement uncertainty must be reported with positive results.

2. Drug and metabolite testing of blood samples for drug classes to include cannabinoids, CNS stimulants, CNS depressants and narcotic analgesics. Positive results must be reported quantitatively. Measurement Uncertainty (MU) must be reported with positive results. Specific analytes and sensitivity of methods should meet requirements set forth in ANSI/ASB Standard 120, Table 1. Additionally, PCP, ketamine and LSD testing should be included.

Human Performance Testing for drug facilitated crimes (DFC) in urine and/or blood samples

(estimated 15-40 samples per year, not to exceed 50 samples per year):

1. Blood and urine samples: Ethanol testing with quantitative reporting for concentrations above 0.01 g/dL. Measurement uncertainty must be reported with positive results.

2. Drug and metabolite testing of urine samples or blood samples when no urine sample is available for drug classes to include GHB, antidepressants, antihistamines, barbiturates, benzodiazepines, cannabinoids, CNS stimulants, miscellaneous, and narcotic analgesics.

Positive results may be reported qualitatively. If results are reported quantitatively, Measurement Uncertainty (MU) must be reported with positive results. Specific analytes and sensitivity of methods should meet requirements set forth in ANSI/ASB

Standard 121, Table 1.

3. Testing of paired blood specimens for any drugs positive in the urine specimen in 2 above. Positive results must be reported quantitatively. Measurement Uncertainty (MU) must be reported with positive results.

3.2 Reporting and Specimen Requirements:

If the Contractor requires the use of any specific packaging or labeling, this will be provided by the Contractor to the CU. The CU will be responsible for packaging and shipping specimens to the Contractor.

Results will be reported within 4 weeks from receipt of specimen, unless additional testing is requested. If results will take longer than 4 weeks, this will be communicated to the CU.

Reports must include measurements of uncertainty and will meet all requirements listed in

ISO/IEC 17025. Specimens will be returned to FBI Lab in original packaging within 6 weeks of completion of testing unless otherwise specified. When possible, specimens shall be returned in a batch as they were received. Email or phone communication to the CU at time of shipping is required. Samples will be returned to the following address:

FBI Laboratory ATTN: Evidence Management Unit 2501 Investigation Pkwy Quantico, VA 22135

3.3 Legal Requirements

Confidentiality Contractor will hold confidential all information submitted by the CU, and derived therefrom, and all terms of the contract. Contractor shall not divulge, publish, or disclose any information regarding any analyses performed pursuant to this contract. Exceptions will be reviewed on a case-by-case basis, requests for exception must be made in writing to the CU. This includes disclosure via any media, including websites, publications, newspapers, newsletters, public announcements, press releases, statements made for advertising or marketing, or by conversation, verbal, written or through electronic means. This applies regardless of whether such information is already available to the public through other means.

Records and information about a case submitted by the CU may only be released by the

Contractor upon written approval by the CU and only in conformance with the provisions of

Federal laws and regulations, including the Freedom of Information Act (FOIA)5 U.S.C. § 552, as well as applicable civil and criminal discovery privileges. If a request is received, please contact the CU.

If Contractor foresees using a sensitive Innovation to analyze a sample pursuant to this contract, notification shall be made to the CU and a separate agreement will be reached regarding the confidentiality of that Innovation before work on the sample is performed.

Confidentiality No personnel working on a case provided by the CU may have a conflict of interest with the

Department of Justice or any law enforcement agency. Contractor and personnel are under a continuing duty to disclose potential conflicts of interest as they arise throughout the duration of this agreement.

Citizenship All personnel performing work for the CU under this contract must be U.S. citizens.

Document Retention Contractor shall retain for a minimum of 5 years the documentation of forensic sample/work product handling, preparation, processing, analysis and conclusions, to include methods, data analysis, settings used, analytical results, chain of custody, and applicable standard operating procedures, quality control data, and any deviations from standard operating procedures.

Reporting All conclusions regarding the samples submitted by the CU shall be documented in writing and the final report shall be provided to the CU upon completion. Results will be reported within 4 weeks from receipt of specimen, unless additional testing is requested. If results will take longer than 4 weeks, this will be communicated to the CU. Reports must include measurements of uncertainty and will meet all requirements listed in ISO/IEC 17025.

Brady/Giglio Information All Upon request by the CU, Contractor shall comply with the disclosure requirements of Brady

v. Maryland, 373 U.S. 83 (1963), and Giglio v. United States, 405 U.S. 150 (1972), and their progeny; examples of such information include, but are not limited to:

• Circumstances that call into question personnel’s integrity or veracity, such as an instance where their words or actions were dishonest or deceitful;

• Any misconduct finding or pending misconduct allegation that could cast doubt upon the accuracy of any evidence, such as a failure to follow mandatory procedures for the collection and handling of evidence, or forensic analysis of evidence;

• Failure of a proficiency or competency test;

• A condition that calls into question personnel’s ability to properly carry out his or her job or to accurately perceive or recall events;

• Animosity toward any group due to race, religion, or gender, expressed verbally or in writing, such as in social media posts;

• Prior criminal conviction, known but uncharged criminal conduct, bankruptcy proceedings;

• Any prior instance where the personnel has provided testimony materially inconsistent with the Department of Justice Uniform Language for Reporting and Testimony.

Production of all materials in compliance with these legal requirements shall be provided directly to the FBI Office General Counsel, the Forensic Science Law Unit via lab_discovery@fbi.gov.

Subpoenas In the event a valid subpoena is served on the Contractor for a case submitted by the CU, personnel summoned shall appear and testify as required by law. Within 72 hours of receipt of a subpoena for a case submitted by the CU, the Contractor shall notify the FBI Office of General

Counsel via lab_discovery@fbi.gov.

4 Key Personnel

The Contractor will ensure all employees conform to requirements in section 3.3.

5 Place of Performance

The primary place of performance will be at Contractor’s offices/laboratory.

6 Deliverables

The Contractor shall provide reported results within 4 weeks from receipt of specimen, unless additional testing is requested. If results will take longer than 4 weeks, this will be communicated to the CU. Reports must include measurements of uncertainty and will meet all requirements listed in ISO/IEC 17025.

The Contractor shall provide a litigation packet for a case upon request by the CU. It is estimated that CU will request a litigation packet for approximately 25% of cases submitted for testing. The return date on litigation packets will be on a case-by-case basis. The Contractor mailto:lab_discovery@fbi.gov mailto:lab_discovery@fbi.gov shall provide monthly status reports to the Contracting Officer (CO) and the Contracting Office

Representative (COR). The format will be agreed to by the Contractor and COR at the start of performance, but the contents shall contain the following, at a minimum: Staffing Summary, Hours and Labor performed, Current Management and Administrative problems, and Action items. The Contractor shall also provide a bi-weekly status report that describes the activities that were completed (highlights), areas of risk, and personnel and their responsibilities for that time period.

The Contractor shall be responsible for providing the following deliverables:

Deliverable Title Deliverable Date SOW Reference

Monthly Status Reports 2nd Wednesday of Every Month 7.0

Bi-weekly Status Reports Every other Tuesday 7.0

7 Electronic Invoicing Requirements

The Federal Bureau of Investigation (FBI) requires vendors to submit invoices and supporting documentation electronically through the Invoice Processing Platform (IPP). IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury’s Bureau of the Fiscal

Service (Treasury) in partnership with the Federal Reserve Bank of St. Louis (FRSTL). IPP is available at no cost to any commercial vendor or independent contractor doing business with a participating government agency. To learn more about IPP, please visit IPP.gov.

Invoice Submission

Vendors are required to create and submit electronic invoices using the IPP system. Invoices submitted by email will not be accepted. This requirement applies immediately upon contract award. For contract-specific questions, please contact the designated contracting officer for your contract.

Obtaining IPP Access

If your company has already enrolled in IPP:

You will not be required to re-register. Please contact your company's IPP account administrator so that he/she may add you as an additional user to your company’s IPP Collector account.

If your company has NOT enrolled in IPP:

Your company will be auto-enrolled for IPP using information from your SAM.gov account. Your company's Primary Electronic Business Point of Contact (POC) will be designated as an IPP administrator.

This POC will be contacted by email to register when the FBI initiates the enrollment process through

IPP. To prevent enrollment delays, please ensure your designated Electronic Business POC in SAM.gov is up to date.

Your company’s IPP administrator will be responsible for initial account registration as well as creating and managing your company’s IPP users and permissions. Please note that due to U.S. Department of the Treasury guidelines, IPP cannot set up User IDs using a shared email address.

How to register for IPP:

1. Once FBI initiates the enrollment process, your company’s designated Electronic Business POC in

SAM.gov will receive two emails from IPP Customer Support (ipp.noreply@mail.eroc.twai.gov):

• The first email contains the initial administrative IPP User ID

• The second email, sent within 24 hours of receipt of the first email, contains a temporary password

• You must log in with the temporary password within 30 days

2. Registration is complete when the initial administrative user logs into the IPP web site with the User

ID and password provided and accepts the IPP rules of behavior. Additional user accounts, including administrators, can be created after initial login.

Training

Vendor training materials, including a first-time login tutorial, are available on the IPP.gov website. Once you have logged in to the IPP application, you will have access to user guides that provide step-by-step instructions for all IPP capabilities ranging from creating and submitting an invoice to setting up email notifications.

Additional Support

IPP Customer Support Team is available Monday through Friday from 8:00 am to 6:00 pm EST

•Phone: (866) 973-3131 or Email: IPPCustomerSupport@fiscal.treasury.gov

•For answers to frequently asked questions, visit the Vendor FAQ page on the IPP.gov web site.

8 Government Furnished Equipment or Information

The Government will not provide any equipment or materials outside of samples submitted for testing and associated case information.

9 Personnel Availability

The Contractor will determine working schedule at their offices/laboratory to meet timeframes specified in section 3.2.

10 Security Requirements

The Contractor will not have access to any Government systems or locations. All information provided to the Contractor will be unclassified.

11 Government Representatives

The functions inherent to this contract shall be performed by the designated Contracting

Officer. The duly assigned COR shall ensure all actions pertaining to this contract are requested via the Contracting Officer.

11.1 Contracting Officer Representative

The COR will be identified via letter of COR delegation authority for this contract. The COR is responsible, as applicable, for: receiving all deliverables, inspecting and accepting the supplies or services provided hereunder in accordance with the terms and conditions of this contract;

providing direction to the Contractor which clarifies the contract effort, fills in details or otherwise serves to accomplish the contractual Scope of Work; evaluating performance; and certifying all invoices/vouchers for acceptance of the supplies or services furnished for payment.

The COR does not have the authority to alter or modify the Contractor's obligations, contract terms, conditions, specifications, or cost. If as a result of technical discussions, it is in the

Government’s best interest to alter/change contractual obligations or the Scope of Work, the

CO shall issue such changes.

12 Travel and Other Direct Costs

No travel is authorized by the Government and no travel costs shall be paid.

Other Direct Costs (ODCs) are authorized only for shipping costs for returning samples to the

CU. When possible, samples shall be returned in a batch as they were received. Shipping costs shall be agreed upon prior to start of contract.