ATTACHMENT 6 – STATEMENT OF WORK

SECTION C

C.1 BACKGROUND

18 U.S.C. Section 3154 and 3672 provides the Director of the Administrative Office of the U.S.

Courts (AOUSC) with the authority to contract with public or private agencies for the detection and care of alcohol or drug dependent persons or those with psychiatric disorders, to include the authority to contract for necessary testing of those individuals.

In accordance with 18 U.S.C. Section 3154 and 3672, persons under investigation or the supervision of the Federal Probation and Pretrial Services system in the contiguous United States, Alaska, Hawaii, Puerto Rico, Guam, and the U.S. Virgin Islands may be required to participate in a comprehensive urine testing program to determine the presence and abuse of drugs. Initial screening of specimens may be conducted at on-site laboratories located in Government facilities nationwide. These facilities may be located within judicial facilities or premises. Some on-site laboratories operate as a regional laboratory which means they accept samples from other offices for initial screening and reporting of results.

For initial installation after the kick-off meeting, there are 13 probation and pretrial offices with on-site laboratories, and 5 probation and pretrial offices operating on-site regional laboratories.

The 13 probation and pretrial offices with on-site laboratories, and 5 probation and pretrial offices operating on-site regional laboratories shall be referred to as districts. (Reference Attachment 2 - Laboratory locations, for a listing of approved on-site laboratories requiring initial set-up post award).

C.2 PURPOSE

To provide equipment, reagents, supplies, a data management program, training and consumables required for U.S. Probation and Pretrial Services Offices to nationally operate instrumented screening urine testing facilities within the United States Probation and Pretrial Services Offices on-site laboratories (herein after on-site laboratories) located in the contiguous United States, Alaska, Hawaii, Puerto Rico, Guam, and Virgin Islands. This IDIQ is specific to providing equipment, reagents, supplies, data management services and training, and does not include the collection of urine from defendants/persons under supervision.

C.3 GENERAL REQUIREMENTS

C.3.1 – Contractor-Provided Laboratory Equipment & Supplies

Contractors must fully equip each on-site drug testing laboratory with everything required to operate automated analyzers, including:

a. Automated analyzers

b. Forensic-use immunoassay reagents

c. Controls and calibrators

d. All consumables and supplies

e. Appropriate water systems

f. Quality control materials

g. Data management system, hardware, software, and licenses

h. Maintenance for analyzers and water systems

i. Training for analyzer operators

Pricing is based per individual test performed, not per sample.

C.3.2 – Installation of Equipment

Contractors must install all newly manufactured or refurbished equipment for every laboratory under the contract. Equipment provided must meet each lab’s testing volume requirements as defined in Section C.5.2.1.

The contractor shall warrant that each laboratory installation is fully operational, properly configured, and capable of meeting all performance requirements (as stated in Section C.5.2.1 of this order) upon completion of setup. Any deficiencies identified during initial operation must be corrected by the contractor at no additional cost to the Government.

C.3.3 – Adding, Moving, or Removing Laboratories

Throughout the IDIQ contract period:

a. Laboratories or equipment may be added, relocated, or removed at the Government’s discretion.

b. The IDIQ COR will provide written notice of any changes.

c. Costs for installation, relocation, or closures shall be in accordance with prices listed in Attachment 1 – National Drug Lab Price Sheet.

d. All actions under Section C.3.3 — including new laboratory installations, relocations, and closures — must be approved in writing by the Ordering Contracting Officer (CO). The COR may communicate technical details, but only the CO has authority to authorize or modify contract actions.

C.3.3.1 – New On-Site Laboratory Installation

a. The IDIQ COR notifies the contractor in writing when a new lab is created.

b. The requesting district issues a task order.

c. The contractor coordinates installation per Section C.5.2.

d. The requesting district pays installation costs per Attachment 1.

C.3.3.2 – Moving/Relocating a Laboratory

a. The district must notify the contractor and IDIQ COR in writing and issue a task order.

b. The contractor manages the move, including equipment transport and water system decontamination if needed.

c. The requesting district pays relocation costs per Attachment 1.

C.3.3.3 – Laboratory Closure

a. The district must notify the contractor and IDIQ COR in writing and issue a task order.

b. The contractor manages closure activities, including equipment removal and water system decontamination.

c. The requesting district pays closure costs per Attachment 1.

C.3.4 – Nationwide Use

This master IDIQ contract may be used by any district that operates or uses an on-site laboratory anywhere in the United States as stated in Section C.4.

C.3.5 – Revisions

All subsequent contract provisions may be revised as needed, provided changes remain within the overall scope of the contract and comply with agency needs and regulations.

C.4 GEOGRAPHICAL AREA

The contractor shall provide drug-analyzing equipment, on-site urinalysis testing equipment, and all required supplies to on-site laboratories located within the contiguous United States, Alaska, Hawaii, Puerto Rico, Guam, and the U.S. Virgin Islands.

The contractor shall perform all deliveries, installations, maintenance, and support services in these locations in accordance with all contract requirements. The Government retains the right to adjust laboratory locations or service needs within these geographical areas at its sole discretion.

The contractor remains responsible for coordinating with Government personnel to schedule work in a manner that minimizes disruption to Government operations. Any contractor-caused delays, failures to plan, or inadequate staffing shall not relieve the contractor of performance obligations.

C.5 DRUG TESTING EQUIPMENT AND REAGENTS

The contractor shall ensure that all equipment, reagents, and associated materials provided under this contract fully comply with all requirements stated herein and are capable of analyzing specimens accurately, reliably, and efficiently for the entire duration of the contract. The contractor shall maintain all such equipment and reagents in a condition that meets all performance, quality and regulatory standards of the applicable Quality Control Guidelines and Standards as described in section C.6.1 of this contract. Any item that fails to meet these requirements shall be repaired or replaced by the contractor promptly and without entitlement to additional compensation.

C.5.1 Automatic Analyzer

The contractor shall provide analyzers of varying sizes and capacities, including benchtop and high-volume instrumentation. Each analyzer shall possess sufficient throughput to meet or exceed the volume requirements identified in Section C.5.4 for the specific on-site laboratory.

Analyzer selection shall account for laboratory space constraints; however, such constraints shall not relieve the contractor of the obligation to meet required throughput levels. The contractor is responsible for ensuring that all installation considerations, including door frame clearance, laboratory dimensions, water accessibility, and other physical space requirements—are fully assessed in advance and incorporated into the installation plan as identified in Attachment 2 – Laboratory Locations and in accordance with Attachment 5 – Installation Plan, at no additional cost to the Government.

a. The contractor is responsible for selecting water systems of appropriate type and size based on space, water accessibility, and drainage conditions, and shall ensure that all systems comply with applicable Toxicology Lab safety and performance standards of SAMHSA's Mandatory guidelines for Federal Workplace Drug Testing Programs.

(Reference in section C.6.1. Quality Control Guidelines and Standards).

b. a. As part of any water purification system, the contractor shall provide a moisture-sensing device capable of detecting leaks and automatically shutting off the water supply at its source to prevent water damage. The contractor shall remain liable for any damage resulting from failure of the moisture-sensing device or improper installation. The contractor is not responsible for any construction required at the facility.

C.5.2 Equipment

a. The Government does not endorse or recommend any specific manufacturer. The contractor shall provide newly manufactured or refurbished equipment that complies with all regulatory requirements, industry standards, and the performance expectations referenced in Section C.6.1 of this contract. All equipment provided for initial installation shall be fully operational, supported, and capable of analyzing the drugs listed in Section C.5.5 in accordance with Section C.5.4.

b. For refurbished equipment:

i. Each refurbished analyzer shall be accompanied by a current written data quality assurance certificate verifying full reconditioning and successful testing to original equipment manufacturer (OEM) specifications.

ii. The certificate shall demonstrate performance equivalent to new equipment, compliance with all applicable safety standards, and installation of the latest software updates.

iii. The certificate shall include full traceability confirming that the analyzer has not been used after refurbishment and prior to installation in any Government laboratory.

iv. The contractor shall remain fully responsible for the performance, reliability, and safety of all refurbished equipment for the duration of its use under this contract.

For any new laboratory established post-award, the contractor shall provide equipment meeting the performance expectations referenced in Section C.6.1 and the throughput and volume requirements applicable to that laboratory.

c. When replacement of equipment is required, in accordance with the procedures in Section 5.2.2, the contractor shall, within two (2) business days of determining the need for replacement, provide written notification to the on-site laboratory point of contact and the IDIQ COR. This notification shall include the type of instrument to be delivered, full specifications, and delivery and installation details. Installation shall occur no later than seven (7) business days from the date of notification unless otherwise approved in writing by the Ordering CO. If refurbished replacement equipment is provided, the contractor shall supply current certification and documentation of the quality control processes used to verify compliance with OEM specifications. The contractor shall bear all costs associated with replacement, including shipping, installation, calibration, and validation.

C.5.2.1 Performance of Equipment

a. The contractor shall provide all equipment, supplies, calibrators, controls, and consumables necessary to meet the testing needs of each on-site laboratory. This includes, but is not limited to, sample racks, rack trays, lamps, pipettes, test tubes, bar code labels, and any other items required for continuous, uninterrupted testing operations. All equipment provided must meet or exceed the following minimum throughput requirements:

i. At least 100 tests per hour for laboratories conducting 500–4,999 tests per month.

ii. At least 400 tests per hour for laboratories conducting 5,000–11,999 tests per month.

iii. At least 800 tests per hour for laboratories conducting 12,000–20,000 tests per month.

iv. For laboratories conducting over 20,000 tests per month, the contractor shall provide an additional analyzer capable of performing no fewer than 800 tests per hour, ensuring redundancy and uninterrupted operations.

b. The contractor shall provide analyzers capable of producing qualitative results, as defined in Section C.5.4 (Quality Control), for all drugs tested under this contract.

c. The contractor shall provide all software, software licenses, and software updates necessary to support ongoing laboratory operations. Software updates shall be installed promptly and at no additional cost to the Government, ensuring compatibility, security, and uninterrupted functionality.

d. The contractor shall provide comprehensive service, technical support, and maintenance, including preventive and remedial maintenance—to ensure continuous, proper operation of all equipment in accordance with the manufacturers’ instructions. Maintenance shall be performed in a manner that minimizes disruption to Government operations. The contractor shall remain responsible for correcting any equipment deficiencies, failures, or performance issues at no additional cost to the Government.

C.5.2.2 Equipment Failure

a. In the event of an equipment failure, the contractor shall restore the equipment to full operating condition in accordance with Original Equipment Manufacturer (OEM) standards within no more than five (5) business days, unless an extension is approved in writing by the Ordering CO. IDIQ COR concurrence may support the request, but only the CO may authorize additional time. If the contractor fails to meet the five-day requirement, the on-site laboratory shall notify the IDIQ COR, who will coordinate with the CO to initiate corrective action, including escalation under Section C.5.2.4.

b. All repairs, replacement parts, labor, shipping, and transportation costs shall be borne exclusively by the contractor. These costs are included in the fixed price-per-test rate, and the Government shall not incur additional charges under any circumstances.

c. If the equipment cannot be repaired to OEM operating standards, the contractor shall provide new or refurbished replacement equipment (in accordance with Section C.5.2) at no cost to the Government. Within two (2) business days of determining that replacement is required, the contractor shall submit written notice to the on-site laboratory point of contact and the IDIQ COR, including:

i. the type of replacement instrument,

ii. full specifications, and

iii. delivery and installation schedule.

Installation shall occur within no more than seven (7) business days unless otherwise approved in writing by the ordering CO. If refurbished equipment is provided, the contractor shall supply current certification and documentation of the quality control processes verifying compliance with OEM specifications.

d. If the equipment failure or damage resulted from the contractor’s failure to perform required maintenance, improper repair, or negligence, the contractor shall reimburse the Government for any losses, delays, or operational impacts attributable to the contractor’s failure or negligence, including but not limited to lost testing capacity, and additional labor.

C.5.2.3 Maintenance and Service Response Times

a. The contractor shall establish and maintain a dedicated point of contact (name, phone number, and email address) for all on-site laboratories to report equipment failures or service needs. The contractor shall ensure this contact information remains current throughout the contract period.

b. The contractor shall respond to all Government service requests within twenty-four (24) hours by telephone or email. Failure to respond within this timeframe constitutes non-compliance and may trigger escalation under Section C.5.2.4.

c. The response time begins upon the Government’s first bona fide attempt to contact the contractor via email or telephone. The contractor shall maintain systems capable of documenting receipts of service requests.

d. The contractor shall perform preventive maintenance on each analyzer twice per year and shall inspect and verify the performance of all water systems at least twice per year, regardless of manufacturer’s recommendations. Preventive maintenance shall ensure the water system consistently produces Type I water. All preventive maintenance visits shall be scheduled in advance with the laboratory point of contact and shall not disrupt Government operations.

e. All service, maintenance, repairs, parts, labor, and transportation costs shall be the sole responsibility of the contractor. These costs are included in the fixed price-per-test rate.

f. If a site visit is required to repair equipment, contractor repair personnel shall arrive on-site within no more than two (2) business days for both emergency and non-emergency repairs.

Any deviation from this requirement must be communicated to the IDIQ COR and approved in writing by the ordering CO. The contractor shall ensure repair personnel coordinate with the laboratory during normal business hours by proactively coordinating with the laboratory personnel, in advance, to receive access authorization.

C.5.2.4 Escalation Procedures

The contractor shall maintain formal escalation procedures to ensure timely resolution of equipment failures in accordance with Section C.5.2.2.

C.5.3 Certification of Drug Testing Equipment

The contractor shall meet all applicable Federal, state, and local regulatory requirements of Substance Abuse and Mental Health Services Administration (SAMHSA) and U.S. Food and Drug Administration (FDA) that govern the testing of drug abuse. All equipment shall be commercially available, fully supported by the manufacturer, and suitable for forensic use in accordance with industry standards.

All equipment shall be capable of using FDA-approved reagents for the detection of drugs of abuse. The contractor shall ensure full compatibility between the equipment and all reagents, controls, calibrators, and consumables required for proper operation.

The contractor shall provide, upon installation and upon request of the Government, documentation verifying regulatory compliance, including but not limited to manufacturer certifications, FDA clearance information, safety compliance records, and any other evidence necessary to demonstrate that the equipment meets all required standards.

The contractor shall maintain authorized reseller status for all equipment, reagents, software, and related components provided under this contract for the entire period of performance. Loss of authorized reseller status at any point shall constitute non-compliance and shall require immediate written notification to the Contracting Officer, along with a Government-approved corrective action plan at no additional cost to the Government.

C.5.4 Quality Control

a. The contractor shall perform random tests, inspections, and quality-assurance evaluations no less than annually, and more frequently if directed by the Government, to verify that all contractor-provided equipment continues to meet required quality-control standards throughout the duration of the contract. All inspections and test results shall be documented and made available to the Government upon request. Failure to meet quality-control standards shall require immediate corrective action at no cost to the Government.

i. For tests analyzed qualitatively, quality-control samples containing drug concentrations at 25% above and 25% below the assay cutoff shall produce correct results at least 95% of the time. The contractor shall maintain documentation demonstrating ongoing compliance with this requirement. The contractor shall provide a summary report to the COR after each compliance check.

ii. For quantitative creatinine testing, quality-control samples containing creatinine concentrations at 25% above and 25% below the assay cutoff shall produce results within ± 2 standard deviations (S.D.), based on Levy-Jennings values compiled across multiple testing batches performed on different days. The contractor shall ensure that the data collected establishes statistically valid performance trends.

iii. If an on-site laboratory does not initially have established acceptance ranges, the contractor may temporarily use the manufacturer’s acceptance ranges. However, the contractor shall not rely on manufacturer ranges long-term. The contractor shall develop laboratory-specific acceptance ranges within a timeframe approved by the Contracting Officer. These contractor-established acceptance ranges must demonstrate a coefficient of variation comparable to the manufacturer’s acceptance ranges and must be supported by documented validation data. Any deviation from this requirement must be approved in writing by the Contracting Officer.

C.5.5 Drug Testing Reagents

a. The contractor shall provide all ready-to-use liquid reagents, powdered reagents are strictly prohibited—for testing specified drugs of abuse at the cutoff levels identified below. No substitute reagents, reagent formulations, or cutoff-level modifications are permitted unless expressly approved in writing by the IDIQ Contracting Officer (CO).

i. At a minimum, all reagents supplied by the contractor shall meet “forensic use only” designation standards and shall be validated for testing at the prescribed cutoff levels.

ii. The contractor shall achieve the required cutoff levels using reagents appropriate for qualitative analysis of the specified drugs. If the contractor proposes to use customized calibration or analyzer-specific validation procedures to achieve the required cutoff levels, prior written approval from the IDIQ COR is required, with final authority resting with the CO.

b. The contractor shall provide biohazard information and Material Safety Data Sheets (MSDS/SDS) for all reagents and ancillary supplies at the time of delivery. As part of the required training, the contractor shall instruct laboratory personnel on all relevant biosafety procedures, including safe handling, storage, and disposal of reagents and specimens.

c. Unopened reagents shall remain stable for a minimum of six (6) months to one (1) year, in accordance with i and ii below, from the date of receipt when stored under manufacturer-specified conditions (e.g., refrigerated or otherwise). Once opened, reagents shall remain stable for no fewer than twelve (12) weeks, provided they are stored in accordance with manufacturer requirements. The contractor shall replace any reagent that fails to meet these stability requirements at no cost to the Government.

i. For LAB WITH TEST VOLUMES OF 500 – 19,999 the contractor shall guarantee that reagents are stable for at least 1 year.

ii. For labs with test volumes of 20,000 or more, the contractor may, with the approval of the ordering official, provide reagents that may have an expiration date of six(6) months to one year.

d. The contractor shall ensure that delivery of reagents by the carrier of choice occurs within two

(2) business days from receipt of the order. Reagents must be shipped in a manner that:

i. Maintains required temperature conditions throughout transit

ii. Prevents leakage, breakage, or spoilage

iii. Protects integrity and usability of the product

iv. Provides legible packing slips with LOT# and reagent expiration dates, and

v. Prohibits Saturday/Sunday delivery

All shipping, handling, and packaging costs shall be included in the fixed price-per-test rate.

Delivery of non-perishable consumables shall not exceed five (5) business days from receipt of the order.

e. Spoilage: The contractor shall replace any leaking, damaged, or spoiled reagents—whether caused by shipping conditions or instability of the reagent within the required 12-week post-opening period—upon notification by authorized Government personnel. Replacement reagents shall arrive no later than the next business day by 12:00 PM local time, at no additional cost to the Government.

C.5.5.1 Reagent Chart

REAGENT DESCRIPTION CUTOFF

LEVELS

1) Cannabinoids 50 ng/mL

2) Cocaine Metabolite 150 ng/mL

3) Opiates (Based on 300 ng/mL of morphine or other equivalent opiate)

300 ng/mL

4) Amphetamines (Based on 500 ng/mL d-methamphetamine and/or d-amphetamine, but should be able to detect amphetamine, MDMA and MDA at clinical concentrations)

500 ng/mL

5) Benzodiazepines (Based on 200 ng/mL of oxazepam or another equivalent benzodiazepine)

200 ng/mL

6) Creatinine >20 mg/dL

7) Methadone 300 ng/mL

8) Oxycodone 100 ng/mL

9) Buprenorphine 5 ng/mL

10) Barbiturates 200 ng/mL

11) Acetylmorphine (6-AM) 10 ng/mL

12) Fentanyl 1 ng/mL

13) Ethyl Glucuronide (EtG) 500 mg/mL

14) Ketamine 100 ng/mL

15) Phencyclidine (PCP) 25 ng/mL

C.5.5.2 Urine Validity Testing

All tests conducted by the on-site laboratories shall include specimen validity testing for Creatinine to ensure the integrity of the specimen and the reliability of test results. The contractor’s reagent and equipment shall perform and report specimen validity results in accordance with the following criteria:

• Creatinine ≥ 2 mg/dL and ≤ 20 mg/dL shall be reported as “dilute.”

• Creatinine < 2 mg/dL shall be reported as “substituted.”

The contractor shall ensure that all validity testing procedures, calibrations, and reporting methods comply with applicable forensic use only standards and comply with SAMHSA; and remain consistent throughout the duration of the contract. Any deviation from these criteria or any proposed modification to validity-testing procedures shall require prior written approval from the IDIQ Contracting Officer via a contract modification.

The contractor shall maintain complete documentation of all validity testing results and make such records available to the Government upon request.

C.6 INFORMATION TECHNOLOGY SUPPORT

The Drug Test Results (DTR) component of the Federal Judiciary’s Probation and Pretrial Services Automated Case Tracking System (PACTS) tracks drug tests and drug test results in support of Pretrial Services and Probation Offices nationwide. DTR receives and processes test results through an electronic interface with on-site laboratories.

The Federal Judiciary is replacing its current PACTS system (“legacy PACTS”) with PACTS360, which will become operational during the performance period of this IDIQ. During the transition and implementation period, the contractor’s drug-testing data management system shall be fully capable of interfacing with both legacy PACTS and PACTS360, including during periods of parallel operation.

The contractor shall provide a drug-testing data management system with a user interface capable of accepting specimen identifiers, test specifications, and all required data elements. The system shall store and transmit all data elements specified in Attachment 3 – Specifications for Probation and Pretrial Case Tracking System (PACTS) Drug Testing Results (DTR) Component On-Site Laboratory Interface.

The contractor shall identify a designated technical point of contact (TPOC) responsible for coordinating all interface-related activities with the Government for both legacy PACTS and PACTS360. The contractor and the Government shall exchange all necessary technical information—including analyzer specifications, database structures, interface requirements, security considerations, regulatory compliance information, and development environment details—to enable the Administrative Office of the U.S. Courts (AOUSC) to build and maintain the required software interface.

All interface-related changes, modifications, or deviations from contract requirements shall require prior written approval from the Contracting Officer (CO).

1. System Flexibility and Reporting Requirements

The contractor’s system shall include features that support current and future reporting needs, including:

• Customizable database fields and reporting formats

• Robust data-export capabilities

• Compatibility with Government network environments

These features shall comply with the requirements in Attachment 3.

2. Hardware, Software, Training, and Support

The contractor shall provide all hardware, software, training, and technical support necessary to implement and maintain automatic results transfers as outlined in Attachment 3. The contractor shall ensure that all components remain fully functional, secure, and compatible with both legacy PACTS and PACTS360 throughout the contract period.

3. Technical Point of Contact

The contractor shall identify and maintain a qualified technical point of contact responsible for:

• Assisting with interface development

• Troubleshooting results-transfer issues

• Coordinating with AOUSC and on-site laboratories

• Ensuring timely resolution of all interface-related problems

Failure to maintain an active and responsive TPOC shall constitute non-compliance.

4. Technical Assistance and Connectivity Support

The contractor shall provide timely technical assistance to each on-site laboratory and to the Administrative Office as needed to:

• Troubleshoot connectivity issues

• Resolve data-transfer failures

• Maintain secure and reliable communication between systems

• Ensure uninterrupted transmission of drug-testing results

5. I.T. Security

The contractor and any subcontractor shall provide support ensuring its equipment, hardware and software are supported in accordance with Judicial Policy. The contractor shall review, support and comply with Judiciary Policy and Guidance provided in Chapter 3: IT Security, Chapter 6:

Information Systems and Security and Chapter 5: Managing IT Resources. The policy and guidance describes the responsibility to the Judiciary’s security standards and clarifies your responsibilities in case of a breach.

All support shall be provided at no additional cost to the Government.

C.6.1 Quality Control Guidelines and Standards

The contractor’s quality-control features for all data management and laboratory information systems shall include, at a minimum, robust security controls, archival capabilities, historical https://jnet.ao.dcn/policy-guidance/guide-judiciary-policy/volume-15-information-technology/ch-3-security https://jnet.ao.dcn/policy-guidance/guide-judiciary-policy/volume-11-internal-control/ch-6-information-systems-and-security https://jnet.ao.dcn/policy-guidance/guide-judiciary-policy/volume-11-internal-control/ch-6-information-systems-and-security https://jnet.ao.dcn/policy-guidance/guide-judiciary-policy/volume-15-information-technology/ch-5-managing-it-resources data analysis, calibrator and control-result tracking, and Levey-Jennings quality-control charting.

These tools shall be used to monitor, document, and evaluate laboratory performance to ensure continued compliance with all contract requirements.

C.6.1.1

1. The contractor and on-site laboratory personnel shall use quality-control graphs, trend analyses, and track information to identify, investigate, and correct errors or performance issues. The contractor shall provide technical assistance as needed to support corrective actions.

2. All test data e.g. positive, adulterated, substituted, or invalid specimens, shall be archived for no fewer than two (2) years, and for up to five (5) years for designated quality control data types, including but not limited to quality-control data and blind proficiency-test data, semi-quantitative and qualitative results. The contractor shall ensure that archived data remains accessible, secure, and retrievable upon Government request.

3. The system shall support user entry of test data, secure storage of test-result data, and export of data to independent Government systems without degradation, loss, or alteration of data integrity.

C.6.2 Data Management System

1. The contractor shall provide a web-based data management system containing, at a minimum, all database fields, elements, functions, and reports described in Attachment 3 and Section C.6.3. If the contractor utilizes a subcontractor for any portion of the data management system, the contractor and subcontractor remain jointly and fully responsible for compliance with all terms and conditions of this IDIQ.

2. The data management system shall be fully compatible with, and capable of interfacing with, all analyzers and equipment used in each on-site laboratory.

3. The contractor shall provide all required hardware—including CPU, monitor, printer, bar-code scanner, bar-code labels, and bar-code printer—and all necessary software for each workstation within the on-site laboratory. All costs shall be included in the fixed price-per-test rate.

4. The contractor shall provide comprehensive training to all on-site laboratory staff on the use of the data management system, including specimen entry, report generation, and troubleshooting.

5. The contractor shall identify a dedicated point of contact to assist on-site laboratories with any data-management-system questions or problems. The contractor shall respond within one (1) business day of the Government’s first attempt to make contact via email or telephone.

6. The contractor shall provide administrative access rights to specified users.

7. The data management system shall:

a. Electronically record the results of each assay.

b. Read bar-coded specimens.

c. Include fields for specimen ID number and special instructions.

d. Transmit individual test results quantitatively when appropriate to remote locations within two (2) hours of acceptance of the test results.

i. Transmission date and times should be recorded for each test (e.g., Received date and Received Time, Accepted Date and Accepted Time, Delivered Date and Delivered Time.

e. Import calibration and quality-control values from each analyzer.

f. Allow on-site laboratories to:

i. Enter new vendor locations

ii. Add/delete officers or collectors

iii. Add/delete tests when creating a requisition

iv. Correct donor information after testing and before approval

v. Delete duplicate requisitions

vi. Merge duplicate clients g. Produce customized aggregate reports in user-defined categories.

C.6.2.1 Data Management System Equipment and Software Failure

A. In the event of data-management-system equipment failure, the contractor shall restore all equipment to full operating condition within four (4) business days, unless an extension is approved in writing by the Contracting Officer (CO). If the contractor fails to meet this requirement, for escalation and corrective action, the on-site laboratory shall follow guidance in C.5.2.4.

B. All repairs, replacement parts, labor, shipping, and transportation costs shall be borne exclusively by the contractor. These costs are included in the fixed price-per-test rate.

C. If equipment cannot be repaired to full operating condition, the contractor shall provide replacement equipment at no cost to the Government. Replacement shall occur without delay and shall not exceed the timelines established in this section.

D. If equipment failure or damage results from the contractor’s failure to perform required maintenance, improper repair, or negligence, the contractor shall repair or replace the equipment at its sole expense and shall reimburse the Government for any losses attributable to the contractor’s failure or negligence.

C.6.3 Data Management Reports

The contractor shall provide the reports listed below to the IDIQ COR, including all underlying raw data, in Microsoft Excel or XML format. The IDIQ COR shall have final approval authority over the format, structure, and data layout of all reports. The contractor shall also provide ad hoc reports, at no additional cost to the Government, in electronic format upon request. All reports may be modified as deemed appropriate by the IDIQ COR.

A. MONTHLY REPORTS

The contractor shall provide the following reports to the IDIQ COR no later than the 10th of each month:

1. On-Site Drug Testing Financial Report (within 10 days of the start of each quarter): A running monthly expenditure of assays by:

o Ordering district o On-site laboratory o Nationwide totals Arranged by fiscal year.

2. Monthly Laboratory Summary Report (per on-site laboratory): Including:

o Date range o Laboratory name o Itemization of each district submitting samples, with number of samples and tests completed o Monthly cumulative totals of tests and samples

3. Monthly Cumulative Lab Summary Report: Including:

o Date range o Monthly cumulative totals of tests and samples per laboratory, sorted by month and year Arranged by fiscal year.

B. AD HOC REPORTS

Should the local laboratory require the following ad hoc reports, the contractor shall provide the following reports within five (5) business days of request by the IDIQ COR.

1. Positive Results by Reagent Report: This report shall list (a) all positive sample results by district, (b) the percentage of positive sample results, (c) numbers of positive tests by reagent, (d) number of donors with positive results; (e) if diluted, (f) test date, and (g) report date.

2. Positive Results Trend Report: This is a central report of positive results by district, by month, and nationwide that shall include: (a) the number of donors; (b) the number of requisitions (samples); (c)the number of positive results; (d) the percentage of requisitions (samples) that tested positive (i.e. percent positivity rate for samples); and (e) the percent positivity rate by reagent.

3. District Trend Reports: This report shall include: (a) the monthly number of requisitions (samples)by district and collection site; (b) the number of tests by district and collection site. At the Government's discretion, the contractor shall produce a nationwide trend analysis of the national number of tested specimens from month to month, year to year, and over the life of this contract.

4. Diluted Specimen Report: This report shall list: (a) all diluted specimens by on-site laboratory and collection site; (b) if result was positive or negative and for which analyte,

(c) test date, and (d)report date. The report shall summarize the monthly data in table format, by collection site and on-site laboratory, and nationwide, and include the following fields: (g) the number of requisitions; (h)the number of diluted specimens; (I) the percentage of diluted specimens; (j) the number of diluted specimens that were positive; and (k) the percentage of diluted requisitions (specimens) that were positive.

5. Cumulative Tests per Reagent Report: This report shall list the total number of tests completed per all on-site laboratories by reagent.

Each report shall include all fields and data elements specified in the AD HOC REQUEST.

C. LOCAL REPORTING CAPABILITY

The contractor shall ensure that each on-site laboratory can generate the following reports locally for its own data:

1. On-Site Drug Testing Financial Report

2. Calibration and Quality Control Report

3. Laboratory Summary Report

4. Turn-Around Time Report

5. Reagent Use Report

6. Positive Results Trend Report

7. Positive Results by Reagent Report

8. Positive Results by Officer Report

9. Diluted Specimen Report

10. Daily Report (donor name, result, date of collection, specimen number)

C.7 TRAINING

The contractor shall provide all training required under this contract at no additional cost to the Government. All training materials, agendas, and schedules shall be coordinated with the on-site laboratory prior to delivery. Training shall cover all aspects of on-site drug testing operations, including analyzers, reagents, validity testing, and the data management system. The contractor shall also provide an annual remote or virtual refresher training sufficient to maintain operator certification and ensure continued compliance with contract requirements.

C.7.1 Training Program

1. In conjunction with the delivery and installation of equipment and supplies at each on-site laboratory, the contractor shall conduct a two-part certification training program for all laboratory personnel:

a. In-person technical instruction on the use, operation, and maintenance of all equipment, analyzers, reagents, and ancillary systems.

b. administrative instruction on the use of the data management system. This portion may include additional district personnel and may be conducted virtually if approved by the on-site laboratory.

2. The contractor shall provide all in-person certification training at the on-site district laboratory. The contractor is responsible for all costs associated with training, including travel, materials, and instructor time.

3. During the term of the contract, the contractor shall provide additional in-person or virtual certification training for Judiciary personnel who did not receive the initial two-part training. Such training shall be completed within 30 days of notification by the on-site laboratory of new staff requiring certification.

4. The contractor shall promptly notify the IDIQ COR of any training requests received directly from on-site laboratories. No training shall be scheduled or conducted without coordination with the on-site laboratory and notification to the IDIQ COR.

5. All training costs are included in the fixed price-per-test rate.

C.7.2 Certification Training Requirements

At a minimum, contractor-provided certification training shall include the following:

1. Comprehensive instruction covering:

o Drug immunoassay and validity-testing reagents o Instrumentation and analyzer operations o Laboratory database management and interface with the Judiciary’s systems

2. Certification for each operator documenting successful completion of training and demonstration of competence through performance of actual testing operations.

Certification records shall be provided to the on-site laboratory and made available to the Government upon request.

3. Reagent Training: Training on immunoassay reagents shall include

a. Basics of immunoassay drug detection, including antibody specificity and cross-reactivity

b. Detection mechanisms for the proposed technology

c. Cutoff levels for each reagent

d. Package-insert information

e. Interpretation of test results

f. Reagent handling, biosafety considerations, specimen handling, storage, and stability

g. Use of validity-testing reagents and interpretation of results

4. Instrumentation Training: Training on the use of immunoassay and validity-testing reagents on each analyzer type shall include: a. Environmental requirements (temperature, humidity, etc.) b. Basic operations, daily maintenance, calibration, and control procedures c. Programming, data entry, and load-list creation d. Reading and interpreting raw data e. Quality-control practices f. Running proficiency-test specimens g.

Maintenance and troubleshooting h. Actual drug and validity-testing operations i.

Training on ancillary instrumentation (e.g., water purification systems) as applicable.

5. Database Management System and Interface Training: Training shall include: a.

Entry of chain-of-custody data into the database b. Transfer of data from analyzer to database c. Preparation of drug and validity test reports, statistical summaries, and QC reports d. Creation of customized reports e. Provision of reports in both hard-copy and electronic formats f. Archival operations for test, calibration, and control data g.

Data-security requirements and secure data-transmission procedures.

C.7.3 Conferences

Every other year, at the direction and approval of the IDIQ COR, the contractor and the designated representative from the data management system shall attend and present at the On-Site Laboratory Conference. The government anticipates at least two resources, for two days, to travel for the On-Site Laboratory Conference. Attendance shall not exceed two business days.

All travel, lodging, and associated expenses shall be the sole responsibility of the contractor and are included in the fixed price-per-test rate.

C.7.4 Web-Based / Virtual Training

Once per year, the contractor shall provide live web-based or instructor-led virtual training for all on-site laboratories covering:

• Trends in drugs of abuse

• Refresher training on analyzers, reagents, and the data management system

The training shall include an opportunity for real-time questions and answers and shall be recorded. The contractor shall make the recording available electronically to the Judiciary and the IDIQ COR. All costs associated with this training are included in the fixed price-per-test rate.

C.7.5 Software/System Upgrade Training

The contractor shall provide structured training for software or system upgrades within 30 days of adoption. The contractor shall proactively prepare users for changes to reduce knowledge gaps and training shall provide certifications when necessary.

C.8 INITIAL DELIVERY AND INSTALLATION OF EQUIPMENT, SUPPLIES, AND

CONSUMABLES

The contractor shall deliver all equipment, supplies, and consumables, and shall provide all required training, to the on-site district laboratory offices identified in Attachment 2 – Laboratory Locations no later than forty-five (45) business days after the kick-off meeting, in accordance with Attachment 5 – Installation Plan.

The contractor shall not proceed with installation until the Government confirms that the site is ready. The contractor shall coordinate all delivery, installation, training, and service activities with the designated on-site laboratory point of contact. Because these laboratories are located within secure federal courthouses or GSA-controlled facilities, the contractor shall comply with all facility-access requirements, including but not limited to:

• Valid government-accepted identification

• Security screening procedures

• Any additional requirements specified in individual task orders

The contractor is responsible for ensuring that all personnel assigned to installation activities meet these requirements. The contractor shall not be held responsible for delays caused solely by Government actions, including facility-access restrictions or required facility or space modifications.

At installation, if refurbished equipment is provided, the contractor shall furnish the on-site laboratory point of contact with:

• A current certification verifying that the equipment meets all safety, performance, and OEM-equivalent operational standards

• Quality-control inspection and test results demonstrate proper function and compliance with C.6.1 and ISO 17025 Chain of Custody & Sample Integrity requirements for toxicology labs.

The contractor shall also provide copies of this documentation to the IDIQ CO and IDIQ COR within five (5) business days after installation. Failure to provide this documentation shall constitute non-compliance with contract requirements.

C.9 CONTRACT TRANSITION

The contractor shall support a seamless transition into and out of this contract to ensure uninterrupted drug-testing operations at all on-site district laboratories. All transition activities shall be performed at no additional cost to the Government.

C.9.1 INSTALLATION PLAN

The contractor shall complete Attachment 5 – Installation Plan, which outlines the installation schedule for each on-site laboratory and details all required coordination steps.

Following award of the IDIQ contract, the contractor shall:

1. Attend a Kick-Off Meeting within five (5) to ten (10) business days of contract award, as directed by the IDIQ CO.

2. Deliver and install all equipment, supplies, and consumables, and provide all required training on analyzers, reagents, and the data management system within forty-five (45) business days of the Kick-Off Meeting.

All installation activities shall be coordinated with the on-site laboratory point of contact and shall comply with all facility-access requirements for secure federally controlled spaces.

C.9.2 DEINSTALLATION PLAN

At contract expiration, if the Government selects a successor contractor, the incumbent contractor (“Incumbent”) shall develop and implement a comprehensive Deinstallation Plan to minimize service disruption and ensure an orderly transition. The Deinstallation Plan shall be based on the Installation Plan requirements of the successor contract and shall be provided at no additional cost to the Government.

The Incumbent shall:

• Remain fully staffed

• Maintain all required performance levels

• Continue uninterrupted support until the final date of the contract

The Deinstallation Plan shall include coordination with both the Government and the successor contractor to ensure timely removal of incumbent equipment and installation of successor equipment at each on-site laboratory.

At a minimum, the Deinstallation Plan shall include:

1. A detailed schedule for the orderly de-installation of equipment and supplies no more than three (3) business days prior to installation of the successor contractor’s equipment.

2. Identification of a Deinstallation Point of Contact (POC) responsible for coordinating all transition activities with the Government and the successor contractor.

3. Submission of the Deinstallation POC’s name and responsibilities to the COR within ten

(10) business days of the new contract award.

4. Bi-weekly status reports documenting deinstallation progress, including formal and informal updates, risks, delays, and mitigation actions.

5. Completion of a full and accurate data transfer to the Government or successor contractor for all sites, as directed by the COR, at no additional cost to the Government. Data transfer shall include all test results, QC data, calibration data, and any other required records.

The Incumbent shall ensure that all transition activities are performed in a manner that protects data integrity, maintains operational continuity, and avoids any lapse in testing capability.

10. KICK-OFF MEETING

The contractor shall meet with the IDIQ CO and IDIQ COR to discuss contract objectives, transition requirements, and performance expectations no later than ten (10) business days after contract award. Key Personnel shall attend. The Kick-Off Meeting will be conducted virtually unless otherwise directed by the IDIQ CO.