USCA25R0183_0001 - National DRUG LAB RFP 4.30.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

See Block 16C

4. REQUISITION/PURCHASE REQ. NO.

PAD250019

5. PROJECT NO. (If applicable)

PMDCODE

AJ M. Lee, 202-502-2625 Procurement Management Division Administrative Office of the United States Courts One Columbus Circle, N.E.

Suite 3-250 Washington, DC 20544-0001

6. ISSUED BY CODE7. ADMINISTERED BY (If other than Item 6)

9A. AMENDMENT OF SOLICITATION NO.

USCA25R0183

CODE FACILITY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, country, state and ZIP Code) (X)

X 9B. DATED (SEE ITEM 11)

04/23/2025

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X XThe above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers is extended, is not extended, Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 15, and returning __1__copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return _______ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of Amendment 0001 is to:

1) Provide responses to Questions asked.

2) In response to a question, revise Section C.5.1.

3) In response to a question, revise Section C.5.2.3.d.

No other changes are incorporated and terms and conditions remain unchanged.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remain unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

(Signature of person authorized to sign)

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED

By (Signature of Contracting Officer)

16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

USCA25R0183 /0001 - Page 1 of 39

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

0001 Onsite Drug Testing Laboratory (LOT)

Single-award indefinite delivery/indefinite quantity

(IDIQ) contract utilizing Attachment 1 - National

Drug Lab Price Sheet to provide Onsite Drug

Laboratory equipment and services.

Original :

Change:

Total: 1

Lot

Extended Description:All deliverables, equipment delivery, to include initial installation, all training, data base management and interfacing are incorporated into this CLIN. Key Personnel and deliverables (Not separately priced). Delivery Orders under this IDIQ are Firm Fixed Price (FFP) orders.

The period of performance of this IDIQ is a seven (7) year ordering period.

Period of Performance:09/01/2025 - 08/31/2032

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

0002 New Onsite Drug Testing Laboratory (LOT) - post award Single-award indefinite delivery/indefinite quantity (IDIQ) contract to provide a NEW Onsite

Drug Laboratory equipment and services. Delivery

Orders under this IDIQ are Firm Fixed Price (FFP) orders.

Original :

Change:

Total: 1

Lot

Extended Description:The period of performance of this IDIQ is a seven (7) year ordering period.

Period of Performance:09/01/2025 - 08/31/2032

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

0003 Moving/Relocation of Onsite Drug Testing

Laboratory (LOT) - post award Single-award indefinite delivery/indefinite quantity (IDIQ) contract to provide a move/relocation of an Onsite

Drug Laboratory equipment and services.

Original :

Change:

Total: 1

Lot

Extended Description:Delivery Orders under this IDIQ are Firm Fixed Price (FFP). The period of performance of this IDIQ is a seven (7) year ordering period.

Period of Performance:09/01/2025 - 08/31/2032

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

0004 Closing an Onsite Drug Testing Laboratory (LOT) -post award Single-award indefinite delivery/indefinite quantity (IDIQ) contract to

Original :

Change: Lot

USCA25R0183 /0001 - Page 2 of 39

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount provide a CLOSURE of an Onsite Drug Laboratory equipment and services.

Total: 1

Extended Description:Delivery Orders under this IDIQ are Firm Fixed Price (FFP). The period of performance of this IDIQ is a seven (7) year ordering period.

Period of Performance:09/01/2025 - 08/31/2032

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

1001 Option 1: Drug Testing Laboratory (LOT)

Single-award indefinite delivery/indefinite quantity

(IDIQ) contract utilizing Attachment 1 - National

Drug Lab Price Sheet to provide Onsite Drug

Laboratory equipment and services.

Original :

Change:

Total: 0

Lot

Extended Description:All deliverables, equipment delivery, to include initial installation, all training, data base management and interfacing are incorporated into this CLIN. Key Personnel and deliverables (Not separately priced). Delivery Orders under this IDIQ are Firm Fixed Price (FFP) orders.

Three (3) Year Optional Ordering Period (2-90D) Period of Performance:09/01/2032 - 08/31/2035

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

1002 Option 1: New Onsite Drug Testing Laboratory

(LOT) - post award Single-award indefinite delivery/indefinite quantity (IDIQ) contract to provide a NEW Onsite Drug Laboratory equipment and services.

Original :

Change:

Total: 1

Lot

Extended Description:Delivery Orders under this IDIQ are Firm Fixed Price (FFP). The period of performance of this option is a three (3) year ordering period.

Period of Performance:09/01/2032 - 08/31/2035

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

1003 Option 1: Moving/Relocation of Onsite Drug

Testing Laboratory (LOT) - post award

Single-award indefinite delivery/indefinite quantity

(IDIQ) contract to provide a move/relocation of an

Onsite Drug Laboratory equipment and services.

Original :

Change:

Total: 1

Lot

USCA25R0183 /0001 - Page 3 of 39

Extended Description:Delivery Orders under this IDIQ are Firm Fixed Price (FFP). The period of performance of this option is a three (3) year ordering period.

Period of Performance:09/01/2032 - 08/31/2035

CLIN NO. Supplies or Services Quantity Unit of Issue Unit Price Extended Amount

1004 Option 1: Closing an Onsite Drug Testing

Laboratory (LOT) - post award Single-award indefinite delivery/indefinite quantity (IDIQ) contract to provide a CLOSURE of an Onsite Drug

Laboratory equipment and services.

Original :

Change:

Total: 1

Lot

Extended Description:Delivery Orders under this IDIQ are Firm Fixed Price (FFP). The period of performance of this option is a three (3) year ordering period.

Period of Performance:09/01/2032 - 08/31/2035

B.2 Estimated Quantities

The quantities in Attachment 1 – National Drug Lab Price Sheet, listed are estimates of the number of drug pan-el tests expected to be administered.

These figures are estimates only and do not represent a commitment by the Government to purchase specific quantities of the equipment or required services. The estimated quantities are subject to decrease or increase throughout the life of the contract.

B.3 Fixed Rates

B.3.1 Fixed Rates Fully burdened rates for the required equipment and services shall be included in the awarded IDIQ contract as a fixed unit price for each unit of equipment. All offerors are required to complete Attachment 1 – National Drug Lab Price Sheet. The ordering periods are listed in the following CLINs: Ordering period one, CLIN 0001-0004, are a seven-year ordering period and the 2-90D three-year optional ordering period is listed as CLIN 1001-1004. The ordering periods are listed in Attachment 1 – National Drug Lab Price Sheet. Do not re-vise the CLINs.

Equipment, Reagents, all support services, training, supplies, annual maintenance, initial delivery and installa-tion are to be factored into the Price Per Unit.

B.3.2 Delivery Order Pricing Individual firm-fixed price delivery orders will be issued for equipment and services defined in Section C, based on the fixed rates evaluated at time of contract award and included in Attachment 1 – National Drug Lab Price Sheet.

B.4 Minimum Guarantee and Maximum Contract Limitation

This is an Indefinite Delivery/Indefinite Quantity (IDIQ) contract.

The maximum limitations for orders are prescribed in Section I, Clause 4-10 Order Limitations.

The ceiling value of this IDIQ is estimated at $24,000,000.00 over the life of the IDIQ. This value may be ex-ceeded only by modification of the contract.

USCA25R0183 /0001 - Page 4 of 39

Minimum Guarantee: The minimum guarantee of this IDIQ is $750.00, which will represent the equip-ment ordered by the courts and will be obligated against the IDIQ at time of award. As task orders are fulfilled by the individual courts, the minimum guaranteed obligation will be de-obligated once enough orders are issued by the individual courts to meet the minimum guarantee.

The minimum guarantee will be obligated against this IDIQ at time of award against CLIN 0001.

Section C - Descriptions/Specifications/Statement of Work

C-1 Statement of Work

Statement of Work US Courts On-site Drug Laboratory

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 Fed-eral Probation and Pretrial Services system in the contiguous United States, Alaska, Hawaii, Puerto Rico, Guam, and the Virgin Islands may be required to participate in a comprehensive urine testing program to de-termine the presence and abuse of drugs. Initial screening of specimens may be conducted at on-site district laboratories located in Government facilities nationwide. These facilities may be within either federal court-houses or General Services Administration (GSA) contracted space. Some on-site laboratories operate as a re-gional laboratory which means they accept samples from other district offices for initial screening and reporting of results.

C.2 PURPOSE

To provide equipment, reagents, supplies, a data management program, training and consumables required to operate an instrumented screening urine testing facility that will support 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.

C.3 GENERAL REQUIREMENTS/PROJECT SCOPE

C. 3.1 The contractor shall provide each on-site district drug testing laboratory with automated analyzers, forensic use immunoassay reagents, controls, calibrators, all supplies and consumables necessary to operate the analyzers, appropriate water system(s), quality control, a data management system, all hardware, all software including software licenses, maintenance of analyzers and water systems, training and training materials for analyzer operators. All costs shall be factored into the contractor's reagent fixed-price per-test cost, as specified in Attachment 1 - National Drug Lab Price Sheet, to include delivery and installation costs, as well as any asso-ciated contractor and/or subcontractor travel related expenses. A sample may have multiple tests performed;

however, the contractor's pricing structure is not based on the sample, but on the individual tests performed, e.g.

cocaine, cannabinoids, etc. On-site laboratories or offices using a laboratory will issue specified task orders for reagent purchases which will be issued against this master indefinite delivery/indefinite quantity (IDIQ) con-tract.

C.3.2 The contractor shall cover all costs of initial installation. The contractor shall provide newly manufac-tured, not refurbished, equipment. There are 13 probation and pretrial offices with on-site laboratories, and 5 probation and pretrial offices operating on-site regional laboratories. Reference Attachment 2 - Laboratory loca-tions, for a listing of approved on-site laboratories requiring initial set-up post award. For initial installation

USCA25R0183 /0001 - Page 5 of 39 after the kick-off meeting, the contractor shall provide all the necessary equipment to meet the testing needs of each laboratory based on the volumes of testing as specified in Section C.5.2.1, Performance of Equipment. All costs shall be factored into the fixed-price per-test as specified in Attachment 1 - National Drug Lab Price Sheet. Therefore, the government shall not be charged separately for the equipment (i.e., analyzer(s), to include calibrators, controls, and consumables required to operate the analyzer, water system(s), data management sys-tem and any hardware and software, including software licenses), quality control, and maintenance nor shall the government be charged for any delivery or installation costs, training, or travel.

C. 3.3 During the term of this IDIQ contract, laboratories and/or equipment may be added or removed at the Government's sole discretion. The IDIQ COR will communicate in writing these changes to the contractor.

Costs related to the installation of new on-site laboratories, relocation of existing laboratories, or closure of laboratories are predetermined by the Government and detailed in Attachment 1- National Drug Lab Price Sheet. These costs encompass all associated expenses, including but not limited to shipment, delivery, installa-tion, removal of the instrument(s), water systems, data management systems, equipment for workstations, labor-atory staff training, and all associated travel costs.

C.3.3.1 New On-site Laboratory Installation: In the event a new laboratory is established after the award, the IDIQ COR will inform the contractor in writing of the new laboratory. The contractor shall then coordinate with the on-site laboratory staff to install newly manufactured, not refur-bished, equipment. The district requiring the new laboratory is responsible for paying the installa-tions costs in accordance with the Government's predetermined pricing table set forth in Attach-ment 1.

C.3.3.2 Moving/Relocating a Laboratory: If an existing laboratory needs to be moved to a new location, either within the same building or to a different site, the district requesting the move must notify in writing both the contractor and IDIQ COR, and issue a task order. The contractor will co-ordinate with the district requesting the move/relocation staff to schedule and manage the move, in-cluding decontamination of water systems if necessary, and transportation of equipment. The laboratory requiring a move/relocation is responsible for paying the move/relocation costs in ac-cordance with the Government's predetermined pricing table set forth in Attachment 1.

C.3.3.3 Laboratory Closure: Should an on-site laboratory need to close, the district requesting the closure shall notify in writing both the contractor and IDIQ COR, and issue a task order. Upon exe-cution of a task order, the contractor shall coordinate with the on-site laboratory staff to schedule and manage the closure, including decontamination of water systems if necessary, and removal of all contractor-provided equipment. The laboratory requiring a move or relocation shall be respons-ible for paying all costs for the relocation in accordance with the Government's predetermined pri-cing table set forth in Attachment 1.

C. 3.4 This master IDIQ contract may be used by individual districts with on-site laboratories loc-ated nationwide.

C.3.5 Unless otherwise stated, all provisions that follow throughout the remaining sections of this master contract may be revised within the overall scope of the contract, as necessary (based on the need and regulations of the judiciary).

C.3.6 No work shall be performed until a task order is received from the requesting district on-site laboratory contracting officer.

C.4 GEOGRAPHICAL AREA

The contractor shall provide drug analyzing equipment, on-site urinalysis testing equipment, and supplies to on-site laboratories within the contiguous United States, Alaska, Hawaii, Puerto Rico, Guam, and the Virgin Is-lands. The contractor shall not be held responsible for delays caused by the Government or due to scheduling issues related to required modifications to space and/or facilities.

C.5 DRUG TESTING EQUIPMENT AND REAGENTS

The contractor shall ensure that all equipment provided and installed is newly manufactured and meets or ex-ceeds the requirements stated herein to analyze specimens accurately and efficiently over the life of the con-

USCA25R0183 /0001 - Page 6 of 39 tract.

C.5.1 Automatic Analyzer

a) The contractor shall provide newly manufactured different size and capacity analyzers, including benchtop and high-volume instrumentation. However, each analyzer must have the appropriate through-put to meet the volume requirements identified in C.5.4 for each on-site laboratory. The selection of the size and num-ber of analyzers may vary based on the space considerations of the on-site laboratory (e.g. despite volume, some labs may require benchtop system(s) due to space limitations, or there may need to be installation considera-tions regarding physical space requirements, e.g. door frame, laboratory space dimensions, water accessibility, etc.).

b) The contractor shall provide any water system(s) including additional water system supplies (i.e. specific water, salt, etc.) needed to operate the instrument. The selection of the type and size of the water system may vary based on the space, water accessibility, and drain considerations of the on-site laboratory.

i. As part of any water purification system, the contractor shall provide a moisture sensing device that will detect moisture and stop the water supply at its source in the event of a leak, to prevent water damage.

C.5.2 Equipment

a) The contractor shall provide the government with newly manufactured, not refurbished, equipment for the initial installation of each on-site laboratory which tests and analyzes the drugs listed in C.5.5 and is operational and supported in accordance with section C.5.4. Additionally, if a new laboratory opens post-award, the con-tractor shall provide the government with newly manufactured, not refurbished, equipment that meets the appro-priate through-put and volume requirements for that laboratory.

b) In the event there is a need for replacement of any equipment, the contractor shall submit, in writing, the specifications and delivery information to the on-site laboratory point of contact and the IDIQ COR, no later than ten (10) calendar days prior to planned installation.

C.5.2.1 Performance of Equipment

a) The contractor shall provide all the required equipment and supplies, including but not limited to calibrat-ors, controls, and consumables, to meet the testing needs of each on-site laboratory. The contractor shall provide equipment that is capable of testing specimens based on the following volume and testing requirements:

i. No less than 100 tests (test represents an individual analyte, e.g. cocaine) per hour for laboratories conducting between 500 and 4,999 tests per month;

ii. No less than 400 tests (test represents an individual analyte) per hour for laboratories conducting between 5,000 and 11,999 tests per month;

iii. No less than 800 tests (test represents an individual analyte) per hour for sites conducting between 12,000 and 20,000 tests per month.

iv. For laboratories conducting over 20,000 tests (test represents an individual analyte) per month, the contractor shall provide an additional analyzer capable of testing no less than 800 tests per hour.

b) The contractor shall provide analyzers that are able to produce qualitative (Defined in Section C.5.4, Qual-ity Control) results for all drugs tested.

c) The contractor shall provide software (including licenses) and software updates to meet the needs of each on-site laboratory, as approved by the IDIQ COR.

d) The contractor shall provide technical support and maintenance including preventive and remedi-al maintenance to ensure continual proper operations of the equipment.

C.5.2.2 Equipment Failure

a) In the event of an equipment failure, the contractor shall ensure that all equipment in laboratories shall be returned to operating condition in accordance with Original Equipment Manufacturer (OEM) standards within seven (7) calendar days unless approved in writing by the COR. If the contractor fails to provide resolution at the government's site within the seven (7) calendar day requirement, the on-site laboratory shall contact the IDIQ COR for resolution assistance.

b) All repairs, parts, labor, and transportation costs shall be at the expense of the contractor (pricing is incor-porated into the fixed price-per-test cost).

USCA25R0183 /0001 - Page 7 of 39

c) If equipment is not operable and needs to be replaced due to an inability to repair the equipment to operat-ing condition in accordance with OEM, the contractor shall provide newly manufactured equipment to replace the inoperable equipment. In the event the contractor cannot timely provide newly manufactured equipment due to delivery delays, the contractor is authorized to provide refurbished equipment until the new equipment is able to be delivered and installed but no later than 120 days. These considerations would be made on a case-by-case basis and under direct consultation with the IDIQ COR, with all expense on the contractor (pricing is incorporated into the fixed price-per-test cost).

d) If equipment failure or damage is a result of the contractors’ failure to perform or negligence in performing repairs, the contractor shall provide repair or replacement at its expense. The contractor shall reimburse the agency for losses attributable to the contractor’s failure or negligence.

C.5.2.3 Maintenance and Response Times

a) The contractor shall establish a point of contact (name, phone number, and e-mail address) for use by the on-site laboratories in providing response to contractor equipment failures.

b) The government has a twenty-four (24) hour response requirement whereby the contractor shall respond either by telephone or email to the requesting government official.

c) The response time starts after the government's first bona fide attempt to contact the contractor either by email or telephone that remedial maintenance or repair is required.

d) The contractor shall provide preventative maintenance at each on-site laboratory for the analyzer(s) twice a year, beginning at installation, and check water system(s) a minimum of twice per year to ensure the system is producing type I water.

e) All maintenance, repairs, parts, labor, and transportation costs shall be at the expense of the contractor (pricing is incorporated into the fixed price-per-test cost).

f) If a site visit is needed to repair equipment, repair personnel shall arrive on site within two business days for emergency and nonemergency repairs. Any exceptions to the time frame shall be communicated by the con-tractor to the IDIQ COR. The contractor shall have access during normal business hours.

g) Emergency maintenance and repair work is defined as maintenance or repair necessary to correct an exist-ing or imminent failure to meet the Original Equipment Manufacturer (OEM) standards.

C.5.2.4 Escalation Procedures The contractor shall have escalation procedures in place in case the contractor is unable to return the equipment to proper operating condition within the required response time. A copy of these procedures shall be provided to the Government upon award. In conjunction with the contractor, the Government reserves the right to add, de-lete or modify these procedures if necessary.

C.5.3 Certification of Drug Testing Equipment Contractor supplied equipment shall meet regulatory requirements to test for the presence of drugs of abuse. All equipment shall be commercially available. The equipment shall be capable of using reagents approved by the

FDA.

C.5.4 Quality Control

a) The contractor will perform random tests and inspections, at least annually, to ensure that the contractor provided equipment meets the quality control standard throughout the duration of the contract.

i. For those tests being analyzed qualitatively, quality controls with drug concentrations at 25% above the assay cutoffs and 25% below the assay cutoffs should produce correct results at least 95% of the time.

ii. For creatinine tests being analyzed quantitatively, quality controls with creatinine concentrations at 25% above the assay cutoffs and 25% below the assay cutoffs should produce results that fall within +/- 2 S.D.'s (standard deviations), based on the Levy Jennings values compiled over multiple testing batches analyzed on different days.

iii. Initially, the on-site district laboratory may not have established acceptance ranges, therefore the contractor is allowed to utilize the manufacturer’s acceptance range. However, the contractor cannot continue to use the manufacturer’s acceptance range long term. The contractor shall be required to establish their own ac-ceptance range and additionally the contractor’s acceptance range must demonstrate a similar coefficient of

USCA25R0183 /0001 - Page 8 of 39 variation to the manufacturer’s acceptance range.

C.5.5 Drug Testing Reagents

a) The contractor shall provide ready-to-use liquid reagents to use to test for specified drugs of abuse at the specified cutoff levels set below.

i. At a minimum, the reagents provided by the contractor shall meet forensic use standards for testing at the prescribed cutoff levels identified below.

ii. The contractor shall obtain the required cutoff levels using a reagent in the qualitative analyses of the specified drug. In the event the contractor proposes to use customized calibration with analyzer valida-tions to obtain the required cutoff levels, the contractor must first receive approval from the IDIQ COR.

b) The contractor shall provide non-liquid reagents with notification to the on-site laboratory and the IDIQ COR, when ready-to-use liquid reagents are not available.

c) The contractor shall supply bio-hazard information and Material Safety Data Sheets for all reagents and ancillary supplies, at delivery; and provide as part of the training specific bio-safety issues regarding specimen and reagent handling.

d) Unopened reagents shall be stable for one year from date of receipt, when stored, refrigerated, or as spe-cified by the manufacturer, and stable for at least 12 weeks once opened and stored as specified by the manufac-turer.

e) The contractor shall ensure that delivery of reagents by the carrier of choice does not exceed two (2) busi-ness days from receipt of the order. The contractor shall ensure that the reagents are shipped in a manner that maintains acceptable reagent temperatures throughout the entirety of the shipping process and that packaging prevents goods from leaking, spilling, or spoilage. All shipping costs shall be factored into the fixed-price per-test cost. The contractor shall ensure that delivery of non-perishable consumables by the carrier of choice does not exceed five (5) business days from receipt of the order.

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 (The automated analyzer provided shall be capable of providing quantitative creatinine levels in urine as identified in C.5.6.)

Normal: >20 mg/dL Dilute: 2-20 mg/dL Substituted: <2mg/dL

7) Methadone 300 ng/mL

8) Oxycodone 100 ng/mL

9) Buprenorphine 5 ng/mL

10) Barbiturates 200 ng/mL

11) 6 AM 10 ng/mL

12) Fentanyl 1 ng/mL

13) Ethyl Glucuronide (EtG) 500 mg/mL

14) Ketamine between 50 - 100 ng/mL

C.6 INFORMATION TECHNOLOGY SUPPORT

The Drug Test Results Component (DTR) of the Federal Judiciary’s Probation and Pretrial Services Automated

USCA25R0183 /0001 - Page 9 of 39

Case Tracking System (PACTS) tracks drug tests and drug test results in support of Pretrial Services and Proba-tion Offices within the U.S. Court System. DTR utilizes an electronic interface with the on-site laboratories to automatically receive and process results of tests performed. The Federal Judiciary is in the beginning phase of replacing its current PACTS system. The new system will be installed and operational sometime during the performance period of the IDIQ.

The contractor's drug testing system shall include a data management system with a user interface that accepts specimen identification and test specifications. The data management system shall be capable of storing the data elements specified in Attachment 3 - Specifications for Probation and Pretrial Case Tracking System (PACTS) Drug Testing Results (DTR) Component On-Site Laboratory(s) Interface.

The contractor and the government shall share technical information (i.e, Analyzer Specifications, Database In-formation, Interface requirements, Security Considerations, Regulatory Compliance, Development Environ-ment) to enable the AOUSC to build a software interface between the analyzer database and PACTS.

a) The contractor's system shall provide features that affect the current and future ability of the system to ac-commodate evolving reporting needs including ease of customization of the database fields and reports; the data export features of the software; and the compatibility of the system on a network (Reference Attachment 3 - Specifications for Probation and Pretrial Case Tracking System).

b) The contractor shall provide the hardware and software systems, training, and support, and develop pro-cedures to implement automatic results transfers as outlined in Attachment 3 - Specifications for Probation and Pretrial Case Tracking System.

c) The contractor shall identify a technical point of contact to assist in resolving the results-transfer prob-lems.

d) The contractor shall provide technical assistance to each on-site laboratory and the Administrative Office as needed for troubleshooting and establishing connectivity with the contractor's system.

C.6.2 Quality Controls The Contractor(s) Quality controls of the contractor's systems shall include, but are not limited to, security, archival capabilities, historical data analysis, calibrator and controls results tracking, and Levey-Jennings qual-ity control charts, which shall be used to plot laboratory quality control results.

a) The contractor and on-site laboratory personnel shall use these quality control graphs and tracking inform-ation to determine and correct errors or problems.

b) All test data shall be archived for a minimum of two years and up to five years for certain data (e.g., qual-ity control data, and blind proficiency test data).

c) The system shall support user input of test data, storage of test results data, and export of data to an inde-pendent computer system.

C.6.3 Data Management System

a) The contractor shall provide a data management system that is web based and contains at a minimum the database fields, elements, functions, and reports described in Attachment 3 - Specifications for Probation and Pretrial Case Tracking System and C.6.4 of this contract.

b) The data management system shall be compatible and interface with the analyzers and the equipment of each on-site laboratory.

c) The data management system shall include the hardware (central processing unit (CPU), monitor, printer, bar-code scanner, bar-code labels, and bar-code printer) and necessary software. The contractor shall provide this equipment per workstation located within the on-site laboratory; all costs shall be factored into the fixed price-per-test cost.

d) The contractor shall provide training for all on-site laboratory staff on use of the Data Management Sys-tem, to include daily entry of specimens, as well as running report.

e) The contractor shall identify a point of contact to assist on-site laboratories in resolving any questions or problems within one business day related to the Data Management System. The response time starts after the government's first bona fide attempt to contact the point of contact either by email or telephone.

f) The data management system shall:

i. Electronically record the results of each assay;

USCA25R0183 /0001 - Page 10 of 39

ii. Read bar-coded specimens;

iii. Include a field for specimen ID number (assigned during collection) and a field for special in-structions;

iv. Report and electronically transmit individual test results, quantitative when appropriate, from the database to remote locations within 2 hours of acceptance of the test results;

v. Import calibration and QC values from the analyzer to the Data Management System;

vi. Grant on-site laboratories the ability to enter new vendor locations, add/delete officers or collect-ors as necessary, add/delete tests while creating a requisition, correct donor information after testing and before approving results, and delete a duplicate requisitioned test, merge duplicate clients;

vii. Produce customized aggregate reports of test results in user-defined categories.

C.6.3.1 Data Management System Equipment Failure

a) In the event of an equipment failure, the contractor shall ensure that all data management equipment in laboratories shall be returned to operating condition in accordance with Section C.6 within seven (7) calendar days unless approved in writing by the COR. If the contractor fails to provide resolution at the government's site within the seven (7) calendar day requirement, the on-site laboratory shall contact the IDIQ COR for resolu-tion assistance.

b) All repairs, parts, labor, and transportation costs shall be at the expense of the contractor (pricing is incor-porated into the fixed price-per-test cost).

c) If equipment is not operable and needs to be replaced due to an inability to repair the equipment to operat-ing condition, the contractor shall provide newly manufactured equipment to replace the inoperable equipment.

d) If equipment failure or damage is a result of the contractors’ failure to perform or negligence in performing repairs, the contractor shall provide repair or replacement at its expense. The contractor shall reimburse the agency for losses attributable to the contractor’s failure or negligence.

C.6.4 Data Management Reports

a) The contractor shall provide access to the following reports to the IDIQ COR by the 10th of each month on activities of the prior month to include the raw data used for these reports in Microsoft Excel or XML format. Graphical representations shall not be provided with the raw data. The IDIQ COR will be responsible for final approval of the format and data layout of the monthly reports provided to the IDIQ COR. The con-tractor shall also provide access to monthly/ad hoc reports, at no additional cost to the government, in electronic format as requested by the IDIQ COR. All reports may be modified as deemed appropriate by the IDIQ COR and the contractor.

The contractor shall provide reports to the IDIQ COR by the 10th of each month to include the following:

(1) On-Site Drug Testing Financial Report (within 10 days of the start of each quarter): This report shall list a running monthly expenditure of assays by: (a) each ordering district, (b) per on-site laboratory, and (c) nation-wide. The contractor shall arrange the On-Site Drug Testing Financial Report by each fiscal year.

(2) Monthly Laboratory Summary Report Breakdown per On-Site Laboratory (each month): This report shall include: (a) the date range for the report; (b) name of on-site laboratory; (c) a itemization of each district site providing samples to the on-site laboratory with the number of samples and tests completed per office; and (d) a monthly cumulative total of the number of tests and samples per each on-site laboratory.

(3) Monthly Cumulative Lab Summary Report (each month): This report shall include: (a) the date range of the report; and (b) a monthly cumulative total of tests and samples completed per on-site laboratory sorted by month and year. The contractor shall arrange the Cumulative Lab Summary Report by each fiscal year.

b) The contractor shall provide the following reports within 5 business days of request by the IDIQ COR.

When requested, the IDIQ COR will specify the time period for the report:

(1) Positive Results by Reagent Report: This report shall list (a) all positive sample results by each ordering 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 monthly central report of positive results by district and nation-wide 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.

USCA25R0183 /0001 - Page 11 of 39

(3) District Trend Reports: This report shall include: (a) the monthly number of requisitions (samples) by dis-trict 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 collec-tion site; (b) if result was positive or negative and for which analyte, (c) test date, and (d) report date. The re-port 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.

c) The contractor shall provide all on-site laboratories, under the contract, the capability to run the following reports locally for data belonging to their individual laboratory:

i. On-Site Drug Testing Financial Report,

ii. Calibration and Quality Control Report,

iii. Laboratory Summary Report showing Number of Samples based on selected date range, to include daily count(s) with a cumulative total,

iv. Turn-around Time Report,

v. Reagent Use Report,

vi. Positive Results Trend Report,

vii. Positive Results by Reagent Report,

viii. Positive Results by Officer Report,

ix. Diluted Specimen Report, and

x. Daily Report including name of donor, result, date of collection, and specimen number.

C.7 TRAINING

The contractor shall provide all training within the terms of the contract. All training materials and class sched-ules shall be coordinated with the on-site laboratory prior to the scheduling and delivery of all training. The contractor shall provide training that includes, all aspects of the on-site testing, specifically the instruments (analyzers), reagents and database training. The contractor shall provide a remote or virtual annual training re-fresher course sufficient to maintain certification.

C.7.1 Training Program

a) Within 7-days of the installation of the laboratory equipment and instruments, the contractor shall conduct a two-part certification training session for all laboratory personnel as follows:

i. Technical instruction on how to use and maintain the equipment and reagents, and

ii. Administrative instruction on how to use the data management system. Training on the data management system may include additional district personnel.

This training shall be coordinated and conducted in conjunction with the delivery and installation of equipment and supplies to each on-site laboratory location.

b) The contractor shall provide the certification training at the on-site district laboratory. The contractor shall be responsible for all training and costs incurred for the training of those

c) During the term of this contract, the contractor may be required to provide additional certification training to Judiciary personnel who did not receive the initial two-part training session as stated above. Training shall be completed within 30 days of notification to the contractor by the on-site laboratory of the new laboratory staff needing certification training.

i. The contractor shall promptly notify the IDIQ COR of any training requests received directly from the on-site laboratories.

(d) All training prices are factored into the fixed price-per-test cost.

C.7.2 Certification Training Requirements At a minimum, the contractor provided certification training shall meet the following requirements:

USCA25R0183 /0001 - Page 12 of 39

1. Training shall cover the following elements: drug immunoassay and validity testing reagents; instrumenta-tion; and laboratory database management/interface with court’s database systems.

2. Training shall include certification for each operator documenting successful completion of training and demonstration of competence through the performance of actual testing operations.

3. Reagents. Training on the use of the immunoassay reagents shall include the following:

i. Basics of immunoassay drug detection including antibody specificity/cross-reactivity;

ii. Immunoassay detection mechanism for the technology being proposed;

iii. Cutoff levels of each reagent;

iv. Package insert information;

v. Interpretation of test results;

vi. Reagent handling (including any possible biohazard issues and specimen handling), storage and stability; and

vii. Training on the use of validity testing reagents and interpretation of results.

1. Instrumentation. Training on the use of the immunoassay reagents and validity test reagents on each type of proposed analyzers shall include the following:

i. Instrument environmental requirements (e.g., temperature, humidity);

ii. Basic instrument operations, including daily maintenance procedures; calibration and control operations;

iii. Programming, data entry/load list;

iv. Reading and interpretation of raw data test results;

v. Quality control practices;

vi. Running proficiency test specimens;

vii. Maintenance and troubleshooting operations;

viii. Actual drug and validity testing operations using drug testing immunoassay and validity testing reagents;

ix. Training on any necessary ancillary instrumentation such as water purification systems if needed.

1. Laboratory Database Management System and Interface. Training on the test system database manage-ment and its interface with the US Court’s systems shall include the following:

i. Transfer of data from chain of custody forms into laboratory database management system;

ii. Transfer of data from analyzer to laboratory database management system;

iii. Preparation of reports, including drug and validity test results, periodic statistical summary reports, and quality control reports;

iv. Preparation of customized reports;

v. Provision of reports through both hard copy means as well as digitally transmitted means;

vi. Archival operations (test, calibration, and control data); and

vii. Security of data and data transmissions.

C.7.3 Conferences Every other year, the contractor shall be required to attend and present at the On-Site Laboratory Conference, through coordination with the IDIQ COR. The presence of the contractor at the conference would not exceed two business days. All travel and lodging expenses associated with attendance at the conference shall be the financial responsibility of the contractor and shall be factored into the fixed-price per-test reagent.

C.7.4 Web-based/Virtual Training Once a year, the Contractor shall provide web-based/virtual training for the on-site laboratories regarding trends on drugs of abuse and refresher training for the analyzers, reagents, and data management system. This training shall be provided live for the on-site laboratories with an opportunity for questions and answers; however, it should also be recorded and available electronically to the Judiciary. All training costs shall be factored into the proposed fixed-price per-test reagent.

C.8 INITIAL DELIVERY AND INSTALLATION OF EQUIPMENT/SUPPLIES

The contractor shall deliver all equipment and supplies and provide training to the On-site District Laboratory offices identified in Attachment 2 - Laboratory locations of the contract no-later-than 60-days after the kick-off

USCA25R0183 /0001 - Page 13 of 39 meeting and within 3 business days of the removal of the incumbent’s equipment, unless alternate arrangements are coordinated and approved, in writing with the IDIQ COR.

The contractor is required to coordinate the delivery and installation of equipment, supplies, and service of equipment with the on-site laboratories. As these facilities are located within either federal courthouses or GSA contracted space, which is secure, there will be additional steps required in the scheduling of the above items.

The contractor is responsible for providing personnel that are able to meet facility requirements to access the fa-cilities, such as valid identification, and any requirements outlined in the individual order(s). The contractor will not be held responsible for delays caused by the Government or due to scheduling issues related to required facility or space modifications (if required).

The contractor shall provide written notification to IDIQ COR of the delivery and installation date for each on-site laboratory to include the type of analyzer(s) and water system(s) that will be installed. Additionally, the contractor shall provide written notification to the IDIQ COR within five business days after installation and training has been completed for each on-site laboratory.

C.9 CONTRACT TRANSITION

C.9.1 PHASE-IN

The contractor shall provide a 60-day phase-in plan five days after award of the IDIQ contract to include:

1. Kick-off meeting for IDIQ

2. Equipment delivery and installation plan

3. Training Plan

4. Reagent and consumable ordering procedures

C.9.2 PHASE-OUT

At the expiration of this contract and if the government selects a "successor" contractor to provide the services performed under this contract, the incumbent contractor (hereto now referred as the "Incumbent") shall minim-ize the transfer of services risks by developing and implementing a comprehensive phase-out plan. The phase-out plan shall include the appointment of a formal phase-out team to interact with the government and the suc-cessor contractor. The incumbent shall minimize service disruptions to the government during the exit process by remaining fully staffed and maintaining quality work performance until the final date of the contract. The in-cumbent's phase-out plan shall include working with both the government and successor contractor to coordin-ate the removal and de-installation of the incumbent's equipment and supplies and the delivery and installation of the successor contractor's equipment and supplies in a manner that minimizes service disruptions at each on-site district laboratory. As a means to provide a smooth transition and continued operation of services, the in-cumbent's transition plan shall include, at a minimum, the following:

(1) 90-day plan / schedule for the orderly de-installation of equipment and supplies;

(2) Identify transition staff and responsibilities, and provide a POC list for coordination with the successor contractor;

(3) This schedule and POC list shall be provided to the COR within fourteen (14) calendar days of new contract award;

(4) Bi-weekly status reports detailing the progress of the transition, including both formal and in-formal reporting procedures; and

(5) The out-going contractor shall ensure the completion of a full data transfer to the government or successor contractor for all sites at the direction of the COR at no additional cost to the govern-ment.

C.10 KICK-OFF MEETING

The contractor shall meet…