USCA25R0183 - National DRUG LAB RFP 4.23 FINAL.pdf

SOLICITATION, OFFER, AND AWARD 1. THIS CONTRACT IS A RATED ORDER UNDER DPAS

(15 CFR 700)

RATING

2. CONTRACT NUMBER 3. SOLICITATION NUMBER

USCA25R0183 SEALED BID (IFB)

X NEGOTIATED (RFP)

4. TYPE OF SOLICITATION 5. DATE ISSUED

04/23/2025

6. REQUISITION/PURCHASE NUMBER

PAD250019

CODE PMD

Procurement Management Division Administrative Office of the United States Courts One Columbus Circle, N.E.

Suite 3-250 Washington, DC 20544-0001

7. ISSUED BY 8. ADDRESS OFFER TO (If other than Item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

N/A. Email submission only 15:00:00 05/08/2025

(Hour) (Date)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 3-100. All offers are subject to all terms and conditions contained in this solicitation.

9. Sealed offers in original and ____________ copies for furnishing the supplies or services in the Schedule will be received at the place specified in item 8, or if handcarried, in the depository located in ______________________________________________________ until ________________ local time _________________

10. FOR

INFORMATION

CALL:

A. NAME

AJ M. Lee AREA CODE

NUMBER

502-2625

EXT.

B. TELEPHONE (NO COLLECT CALLS) C. E-MAIL ADDRESS

aj_lee@ao.uscourts.gov

11. TABLE OF CONTENTS

(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)

PART I - SCHEDULE PART II - CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 24-33

X B SUPPLIES OR SERVICES AND PRICES/COSTS 4-7 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH

X C DESCRIPTION/SPECS./WORK STATEMENT 7-16 X J LIST OF ATTACHMENTS 33

X D PACKAGING AND MARKING 16-17 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 17

K REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

33-37

X F DELIVERIES OR PERFORMANCE 17-18

X L INSTRS., CONDS., AND NOTICES TO OFFERORS 37-40X G CONTRACT ADMINISTRATION DATA 18-20

X M EVALUATION FACTORS FOR AWARD 40-42X H SPECIAL CONTRACT REQUIREMENTS 20-24

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes a minimum offer acceptance period.

In compliance with the above, the undersigned agrees, if this offer is accepted within _______________________ calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

12.

13. DISCOUNT FOR PROMPT PAYMENT 10 CALENDER DAYS(%) 20 CALENDER DAYS(%) 30 CALENDER DAYS(%) CALENDAR DAYS

NUMBER PERCENTAGE

14. ACKNOWLEDGEMENT OF AMENDMENTS (The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

AMENDMENT NO. DATE AMENDMENT NO. DATE

15A. NAME AND

ADDRESS OF

OFFEROR

CODE FACILITY 16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN

OFFER (Type or Print)

15B. TELEPHONE NUMBER

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS IS

DIFFERENT FROM ABOVE - ENTER SUCH

ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c) ( ) 41 U.S.C. 253(c) ( )

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

CODE24. ADMINISTERED BY (if other than Item 7) CODE AFSD Accounting Division, DAS-BAPO-ACC Administrative Office of the United States Courts One Columbus Circle, N.E., Suite 5-300 Washington, DC 20544-0001

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. DATE

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

Judiciary Standard Form 33 (REV. 10-12)

USCA25R0183 - Page 1 of 41

Table of Contents

Section Description Page Number

B Supplies or Services and Prices/Costs B.2 Estimated Quantities B.3 Fixed Rates B.4 Minimum Guarantee and Maximum Contract Limitation

C Descriptions/Specifications/Statement of Work C-1 Statement of Work

D Packaging and Marking 2-45 Packaging and Marking D-1 Order Delivery

E Inspection and Acceptance 2-10 Responsibility for Products 2-5A Inspection of Products 2-5B Inspection of Services

F Deliveries or Performance 2-25A Delivery Terms and Contractor's Responsibilities 2-35 F.o.b. Destination, Within Judiciary's Premises 2-60 Stop-Work Order 7-200 Judiciary Delay of Work F-1 Deliverables

G Contract Administration Data 3-305 Payment by Electronic Funds Transfer-System for Award Management (SAM) Registration ...18 7-1 Contract Administration 7-10 Contractor Representative 7-125 Invoices G-1 Ordering Instructions

H Special Contract Requirements 1-1 Employment by the Government 7-55 Contractor Use of Judiciary Networks 2-65 Key Personnel H-1 Commercial Agreements Unenforceable Terms and Conditions H-2 Travel H-3 Key Personnel Requirements H-4 Unenforceability of Unauthorized Obligations

I Contract Clauses 1-10 Gratuities or Gifts 1-15 Disclosure of Contractor Information to the Public 1-5 Conflict of Interest 2-130 Energy Efficiency in Energy-Consuming Products 2-140 Judiciary IT Security Standards 2-20A Incorporation of Warranty 2-50 Continuity of Services 2-55 Privacy or Security Safeguards 3-105 Audit and Records 3-120 Order of Precedence 3-205 Protest after Award 3-25 Protecting the Judiciary's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment 3-300 Registration in the System for Award Management (SAM) 3-35 Covenant Against Contingent Fees 3-40 Restrictions on Subcontractor Sales to the Judiciary 3-45 Anti-Kickback Procedures 3-50 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity 3-55 Price or Fee Adjustment for Illegal or Improper Activity 4-25 Indefinite Quantity 4-5 Ordering 5-20 Records Ownership 5-30 Authorization and Consent 6-110 Deferred Ordering of Technical Data or Computer Software 6-40 Federal, State, and Local Taxes 6-60 Rights in Data - General 6-85 Commercial Computer Software License

USCA25R0183 - Page 2 of 41

6-90 Notice and Assistance Regarding Patent and Copyright Infringement 6-95 Patent Indemnity 7-100A Limitation of Liability (Products) 7-100B Limitation of Liability (Services) 7-110 Bankruptcy 7-130 Interest (Prompt Payment) 7-135 Payments 7-140 Discounts for Prompt Payment 7-15 Observance of Regulations/Standards of Conduct 7-150 Extras 7-160 Limitation on Withholding of Payments 7-175 Assignment of Claims 7-185 Changes 7-195 Excusable Delays 7-20 Security Requirements 7-205 Payment for Judiciary Holidays 7-210 Payment for Emergency Closures 7-215 Notification of Ownership Changes 7-220 Termination for Convenience of the Judiciary (Fixed Price) 7-230 Termination for Default - Fixed-Price Products and Services 7-235 Disputes 7-25 Indemnification 7-30 Public Use of the Name of the Federal Judiciary 7-35 Disclosure or Use of Information 7-40 Judiciary-Contractor Relationships 7-65 Protection of Judiciary Buildings, Equipment, and Vegetation 7-70 Judiciary Property Furnished "As Is" 7-80 Competition in Subcontracting 7-85 Examination of Records B-20 Computer Generated Forms 4-10 Order Limitations 7-115 Availability of Funds 7-75 Subcontracts B-5 Clauses Incorporated by Reference 2-90D Option to Extend the Term of the Contract 2-57 Protecting, Reporting, and Responding to Incidents Involving Sensitive Information (JUN 2024)

J List of Attachments K Representations, Certifications and Other Statements of Offerors or Respondents

3-15 Place of Performance 3-130 Authorized Negotiators 3-20 Certification Regarding Debarment, Suspension, Proposed Debarment, and Other Responsibility Matters 3-30 Certificate of Independent Price Determination 3-5 Taxpayer Identification and Other Offeror Information 6-50 Representation of Rights in Data

L Instructions, Conditions and Notices to Offerors or Respondents 3-100 Instructions to Offerors 3-210 Protests 3-85 Explanation to Prospective Offerors 3-95 Preparation of Offers 7-60 Judiciary Furnished Property or Services 4-1 Type of Contract B-1 Solicitation Provisions Incorporated by Reference L-1 Instructions to Offerors

M Evaluation Factors for Award 2-85A Evaluation Inclusive of Options 3-70 Determination of Responsibility M-1 Evaluation Criteria

USCA25R0183 - Page 3 of 41

Section B - Supplies or Services and Prices/Costs

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.

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.

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.

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

USCA25R0183 - Page 4 of 41

0004 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.

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

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.

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.

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

1 Lot

USCA25R0183 - Page 5 of 41

Onsite Drug Laboratory equipment and services.

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.

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.

USCA25R0183 - Page 6 of 41

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.

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

USCA25R0183 - Page 7 of 41 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 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

USCA25R0183 - Page 8 of 41

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-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) 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.

USCA25R0183 - Page 9 of 41

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 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, 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-

USCA25R0183 - Page 10 of 41 ceptance range and additionally the contractor’s acceptance range must demonstrate a similar coefficient of 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

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The Drug Test Results Component (DTR) 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 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:

USCA25R0183 - Page 12 of 41

i. Electronically record the results of each assay;

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

USCA25R0183 - Page 13 of 41 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 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

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At a minimum, the contractor provided certification training shall meet the following requirements:

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.