1605C2-24-R-00005 with no COVID.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30 1 87

2. CONTRACT NO. 3. AWARD/

EFFECTIVE DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER

1605C2-24-R-00005

6. SOLICITATION

ISSUE DATE

03/01/2024

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

Dave Chiu

b. TELEPHONE NUMBER

202-693-3092 (No collect calls) 8. OFFER DUE DATE/LOCAL TIME

03/29/2024 1200 ET

9. ISSUED BY CODE CAS 10. THIS ACQUISITION IS X UNRESTRICTED OR SET ASIDE: % FOR:

US Department of Labor Customer Acquisition Services 200 Constitution Ave, NW S-4307

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

621511

Washington DC 20210 SMALL BUSINESS

(SDVOSB)

8(A) SIZE STANDARD: $41.5

11. DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

12. DISCOUNT TERMS 13a. THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

13b. RATING

14. METHOD OF SOLICITATION

REQUEST FOR

BLOCK IS MARKED

SEE SCHEDULE

15. DELIVER TO

US DEPARTMENT OF LABOR

200 CONSTITUTION AVE, NW

ROOM N4643

WASHINGTON DC 20210

CODE

ETA (OCM)

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

16. ADMINISTERED BY

REQUEST FOR

QUOTE (RFQ)

INVITATION

FOR BID (IFB)

CODE

X PROPOSAL

(RFP)

17a. CONTRACTOR/

OFFEROR

FACILITY

18a. PAYMENT WILL BE MADE BY

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

19.

20.

IS CHECKED

21.

SEE ADDENDUM

22.

23.

24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

The U.S. Department of Labor (DOL) has a requirement to provide nation-wide toxicology, and other laboratory testing, materials, equipment, supplies and services to the Employment Training Administration (ETA)’s Office of Job Corps (OJC), as described further in the Performance Work Statement (PWS) for a 12-month base period and four (4) 12-month option periods.

The Government contemplates award of a Time and (Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Government Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE

ARE NOT ATTACHED.

ARE NOT ATTACHED.

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

VALERIE S. PICKARD

31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

Materials contract with firm fixed priced (FFP) test units. Laboratory testing and all related work under the contract shall be billed on a firm-fixed-price, per test basis. For the specified positions of Laboratory Director, Medical Review Officer and Contract Manager the contractor will be paid on a per hour basis for meeting attendance and trainings and other work directed by DOL.

This is an unrestricted competition for NAICS

Code 621511 (Medical Laboratories).

Proposals are due per block 8 on this form.

Pre-Submission Inquiry questions are due by March 8, 2024 12:00pm Noon ET.

Base Period of OJC National Toxicology Support contract Product/Service Code: Q301

Option Period One of OJC National Toxicology

Support contract (Option Line Item) (Anticipated Option Exercise Date) 365

Continued ...

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

STANDARD FORM 1449 (REV. 11/2021) BACK

32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER 34. VOUCHER NUMBER 35. AMOUNT VERIFIED

CORRECT FOR

36. PAYMENT

COMPLETE PARTIAL FINAL

37. CHECK NUMBER

PARTIAL FINAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT 42a. RECEIVED BY (Print)

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

1605C2-24-R-00005

PAGE OF

3 87

NAME OF OFFEROR OR CONTRACTOR

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

Option Period Two of OJC National Toxicology

(Option Line Item) (Anticipated Option Exercise Date) 730

Option Period Three of OJC National Toxicology

(Option Line Item) (Anticipated Option Exercise Date) 1095

Option Period Four of OJC National Toxicology

(Option Line Item) (Anticipated Option Exercise Date) 1460 Product/Service Code: Q301

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

B - SUPPLIES OR SERVICES AND PRICES

B.1 PRICE SCHEDULE

Base Period QUANTITY UNIT ISSUE UNIT PRICE TOTAL

DESCRIPTION

Labor (Hours)

Laboratory Director 96 HR

Medical Review Officer 400 HR

Contract Manager 144 HR

Laboratory Tests (each) NTE*

HIV 4th Generation Tests 50,000 EA

HIV Confirmation Tests 250 EA

Chlamydia Tests 50,000 EA

Gonorrhea Tests 50,000 EA

Toxicology/Immunoassay Urine Screening Tests 60,000 EA

Syphilis Tests 50,000 EA

Syphilis Confirmation Tests 250 EA

Base Period Total

Option Period One QUANTITY UNIT ISSUE UNIT PRICE TOTAL

HIV Confirmation Tests 250 EA

Chlamydia Tests 50,000 EA

Gonorrhea Tests 50,000 EA

Toxicology/Immunoassay Urine 60,000 EA

Screening Tests

Option Period One Total

Option Period Two QUANTITY UNIT ISSUE UNIT PRICE TOTAL

HIV Confirmation Tests 250 EA

Chlamydia Tests 50,000 EA

Gonorrhea Tests 50,000 EA

Option Period Two Total

Option Period Three QUANTITY UNIT ISSUE UNIT PRICE TOTAL

HIV Confirmation Tests 250 EA

Chlamydia Tests 50,000 EA

Gonorrhea Tests 50,000 EA

Option Period Three Total

Option Period Four QUANTITY UNIT ISSUE UNIT PRICE TOTAL

HIV Confirmation Tests 250 EA

Chlamydia Tests 50,000 EA

Gonorrhea Tests 50,000 EA

Option Period Four Total

Total Contract Ceiling (Base plus Options)

* Not to Exceed (NTE)

CONTRACT TYPE

The Government contemplates award of a Time and Materials contract with firm fixed priced (FFP) test units. Laboratory testing and all related work under the contract shall be billed on a firm-fixed-price, per test basis. For the specified positions of Laboratory Director, Medical Review Officer and Contract Manager the contractor will be paid on a per hour basis for meeting attendance and trainings and other work directed by DOL. No other billing or payment shall be made under the contract.

Period of Performance The resultant contract shall consist of one (1) 12-month base period and four (4) 12-month option periods. The dates of the Period of Performance are as follows:

Term Period of Performance

Base Period 05/17/2024 - 05/16/2025

Option Period I 05/17/2025 - 05/16/2026

Option Period II 05/17/2026 - 05/16/2027

Option Period III 05/17/2027 - 05/16/2028

Option Period IV 05/17/2028 - 05/16/2029

C - REQUIREMENTS / PERFORMANCE WORK STATEMENT

PART 1 GENERAL INFORMATION

1.1 Description of Services/Introduction

The Contractor shall provide the Department of Labor (DOL), Employment and Training Administration (ETA), Office of Job Corps (OJC) laboratory screening of Job Corps students for drugs of abuse, testing and identifying students who may have genital infections caused by Chlamydia, and testing and identifying students infected with the Human Immunodeficiency Virus (HIV). This includes supplying all (currently 122) Job Corps centers with all supplies and equipment necessary to collect blood and urine specimens, and to package and ship specimens to the lab where they shall be processed and analyzed. The Contractor shall report test results to all centers. The Contractor shall also inform centers, the Contracting Officer’s Representative /National Office of Job Corps (COR/NOJC) of any problems encountered in the process.

The Contractor shall coordinate all work performed under the terms of the contract with the COR and shall be accountable for compliance with all Federal laws, regulations, and agency implementing policies, procedures, and directives applicable to work performed under the terms of the contract. The Contractor shall perform to the standards specified in this contract.

1.2 Background

Job Corps is a national residential training and employment program established to address the multiple barriers to employment faced by opportunity youth throughout the United States. The program provides comprehensive career development services to students, including academic, career technical training independent living skills, career readiness and success training, and employment support services. The unique combination of services provided in Job Corps is intended to prepare youth to obtain and maintain gainful employment, pursue further education or training, or satisfy entrance requirements for careers in the Armed Forces.

Each Job Corps center has health and wellness staff who provide students with basic medical care that includes managing chronic illness, promoting self-managed health care, and teaching preventive health education to encourage good wellness habits and prevent avoidable illness, injury, and death.

Within 48 hours of the student’s arrival at the center, a cursory health evaluation is performed. Laboratory tests are a required part of the cursory health evaluation. Blood specimens are drawn for hemoglobin or hematocrit determination. These analyses may be done on center or by an outside laboratory. A dip-stick type urine screening is done for sugar and albumin and additional tests are done in case of positive findings. Newly enrolled female students are given an immuno-chemical pregnancy test, a Pap smear if indicated, and a gonococcal infection test. Male and female students provide a urine specimen to check for Chlamydia, Gonorrhea, and Syphilis that is sent to a nationally contracted laboratory.

The center physician may request additional tests to aid in differential diagnosis, observation, or treatment. If these additional laboratory tests are for HIV, Chlamydia, Gonorrhea, or Syphilis, then the nationally contracted laboratory shall perform the analysis.

Trainee Employee Assistance Program (TEAP)

Job Corps implemented a national program on biochemical testing, and alcohol and other drugs of abuse prevention and intervention.

The Trainee Employee Assistance Program (TEAP) mirrors workplace settings and incorporates the employee assistance model. The program incorporates mandatory components for students testing positive on entrance as well as voluntary programming for students who are assessed as at-risk and in need of additional support.

Drug testing information is one part of the comprehensive information that TEAP Specialists rely on to make clinical decisions and support students as they progress in the Job Corps program. Interventions are geared towards providing students with education, coping skills, and other support to cease their drug use. TEAP Specialists provide 15 hours/100 students/week to assess, diagnosis, and intervene with students with substance use issues.

1. All applicants are informed by admissions counselors that Job Corps is drug free.

2. All students are tested for drugs within 48 hours after entry.

3. Students who test positive on entry are placed in the TEAP program which provides assessment, intervention, relapse prevention, education, and referrals as needed.

4. Students testing positive on entry have a follow-up test between 37 and 40 days so results are received on or before the 45th day after entry.

5. Students testing positive on the follow-up test are separated from the Job Corps program unless otherwise stated in the Policy and Requirements Handbook (PRH).

6. Where there is reasonable suspicion of alcohol or drug use on center, students shall be tested and are separated if the suspicion drug test is positive.

7. All drug test specimens are sent to the nationally contracted lab.

Job Corps has a Zero-Tolerance policy that states students who test positive for substance use will face program sanctions, and possible separation from the program.

1.3 Objectives

To fulfill program requirements and provide the safest possible environment for all Job Corps students, the U.S Department of Labor requires clinical laboratory screening services for drugs of abuse, testing and identifying students who may have genital infections caused by Chlamydia, Gonorrhea, or Syphilis, and testing and identifying students infected with HIV.

1.4 Scope

The Contractor shall provide the services and supplies listed below and assumes responsibility for quality control of all laboratory procedures.

HIV Testing

The Contractor shall conduct initial and confirmatory HIV tests (4th Generation or latest industry standard). Requirements include providing all Job Corps centers with centrifuges, sterile needles, vacuum tubes, overnight shipping supplies (e.g., insulated packages, envelopes, labels, dry ice, etc.) and other necessary equipment and supplies.

Toxicology Testing

The Contractor shall conduct laboratory screenings of Job Corps students for drugs of abuse and provide all Job Corps centers with collection equipment and supplies.

Chlamydia Testing

The Contractor shall conduct Chlamydia testing and provide all Job Corps centers with collection equipment and supplies.

Gonorrhea Testing

The Contractor shall conduct Gonorrhea testing and provide all Job Corps centers with collection equipment and supplies.

Syphilis Testing

The Contractor shall conduct Syphilis testing and provide all Job Corps centers with collection equipment and supplies.

Administrative and Project Management Requirements

The Contractor shall participate in weekly meetings with the COR/NOJC to discuss deliverables, projects, and concerns. The Contractor shall also continuously work with the COR/NOJC to assess and determine training needs of center health and wellness staff. This includes, but is not limited to, developing, and conducting training on accessing and navigating the lab reporting system, specimen collection, and transporting specimens. The Contractor shall provide all support services in a collaborative manner.

Reporting Requirements

The Contractor shall submit weekly, monthly, annual, and ad hoc data reports that provide details and problems related to laboratory services covered under the awarded contract. Weekly reports are due each Monday, monthly reports are due within 20 days after the end of each month, and annual reports are due within 30 days of the end of Job Corps’ Program Year. Reports and data shall meet the specifications established by the COR/NOJC. Data provided shall be accurate, timely, reliable, and actionable. Upon contract award or at the conclusion of the transition period, the Contractor shall provide online access to individual student test results.

Technological Capabilities

The Contractor shall have a dedicated computerized and automated test request and result reporting system. At a minimum, the system shall collect and report results and demographic information, generate and track accession numbers, and track and automatically re-supply inventory. The system must be certified HIPAA compliant with internal 128-bit SSL and 3 DES encryption.

The Contractor shall procure, install, and service all equipment. In addition, the Contractor shall work with the Job Corps Data Center (JCDC) on system requirements for back-end reporting and integrating test results into Job Corps’ CDSS Suite of Applications, as applicable.

The Contractor shall provide training and technical assistance to all (currently 122) centers on how to operate the system. The Contractor shall grant system access to the assigned Department of Labor COR and the Office of Job Corps Health and Wellness Program Manager. The system shall have the capability to securely receive confidential inquiries from center health and wellness staff.

Centers for Disease Control

The Contractor shall provide the Centers for Disease Control (CDC), via the COR/Health and Wellness Program Manager, with pertinent statistics and test results during performance of the contract. The Contractor shall notify the COR of any CDC requests for aliquots of positive specimens.

1.5 Period of Performance

The period of performance will be for twelve (12) months Base Period. The initial Base Period of this contract may be extended by up to four (4) one 1-year options, at the Government’s discretion.

The Government may extend the period of performance by providing written notice to the Contractor at least 60 calendar days before the contract expires. This notice does not commit the Government to an extension. If the Government exercises this option, the extension shall be considered to include this option provision. The total duration including the exercise of any options under this order, shall not exceed five (5) years.

Term Period of Performance

Base Period 05/17/2024 - 05/16/2025

Option Period I 05/17/2025 - 05/16/2026

Option Period II 05/17/2026 - 05/16/2027

Option Period III 05/17/2027 - 05/16/2028

Option Period IV 05/17/2028 - 05/16/2029

The Government reserves the right to extend the term of this contract at the prices set forth in Section B in accordance with the terms and conditions contained in clause 52.217-9 entitled, “Option to Extend the Term of the Contract”.

1.6 General Information

Quality Control

The Contractor shall develop and maintain an effective Quality Control (QC) plan to ensure services are performed in accordance with this PWS. In this plan, the Contractor shall develop and implement procedures to identify and prevent defective services, and ensure defective services are resolved and immediately reported to the COR/NOJC, and regular updates are provided to the COR/NOJC while resolving. The Contractor’s QC plan is how they assure the Government their work complies with contractual requirements. At a minimum, the Contractor shall develop quality control procedures that address the areas identified in Technical Exhibit 1- Performance Requirements Summary. The Contractor shall revise and improve the QC plan based on input from the program office and the Contracting Officer. For this contract, the Contractor shall submit the first edition of the Quality Control plan by the end of the first month of contract award. The Government will incorporate the QCP in the contract, and the QCP will no longer be considered proprietary and will be considered releasable under FOIA.

Quality Assurance

The Government shall evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with performance standards. It defines how performance standards will be applied, the frequency of surveillance, and minimum acceptable defect rate(s).

Recognized Holidays

New Year’s Day Labor Day Martin L. King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

Hours of Operation/Place of Performance

Normal hours of operation are Monday through Friday, 8:00 am to 6:00 pm EST.

Place of Performance

The place of performance will primarily be the Contractor’s office/laboratory. However, travel may be required to Job Corps centers, regional offices, the U.S. Department of Labor Headquarters, or other locations to be determined by the Government.

Type of Contract

This will be a Time and Materials contract with firm fixed priced (FFP) test units. Laboratory testing and all related work under the contract shall be billed on a firm-fixed-price, per test basis. For the specified positions of Laboratory Director, Medical Review Officer and Contract Manager the contractor will be paid on a per hour basis for meeting attendance and trainings and other work directed by DOL. No other billing or payment shall be made under the contract.

Security Requirements

The Contractor shall maintain a security system that prevents intrusion, unauthorized release of information, and unauthorized data additions, deletions, or alterations. To prevent unauthorized access to the government’s data, the Contractor’s data center shall be controlled access.

The Contractor is responsible for safeguarding all personally identifiable information (PII) and protected health information (PHI).

The Contractor shall comply with applicable laws pertaining to unauthorized release of PII or other events requiring notification and adhere to the Federal Trade Commission’s (FTC) Health Breach Resources. In addition, the Contractor shall provide the government with requested details on any unauthorized releases of information.

The Contractor shall notify the COR/NOJC as soon as possible, but no later than 24 hours, after discovering a security breach, whether required by law or not. If the government determines a PII breach has occurred, the Contractor shall provide credit monitoring services.

Physical Security

If applicable, the Contractor shall be responsible for safeguarding all government property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

Conservation of Utilities https://www.ftc.gov/business-guidance/resources/data-breach-response-guide-business

The Contractor shall instruct employees on utility conservation practices. The Contractor shall be responsible for operating under conditions that preclude the utilities waste, which includes turning off water faucets or valves after using the amount necessary to clean equipment.

Special Qualifications

Not applicable.

Post Award Conference/Periodic Progress Meetings

The Contractor agrees to attend any post-award conference convened by the Contracting Officer or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The Contracting Officer, Contracting Officers Representative, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance.

During these meetings, the Contracting Officer or Contracting Officers Representative will apprise the Contractor on how the Government views the Contractor's performance and the Contractor shall apprise the Government of any problems. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

Contracting Officer Representative (COR)

A COR will be delegated separately.

Contract Manager

The Contractor shall provide a Contract Manager who shall be responsible for the performance of the work. This person and an alternate shall be designated in writing to the Contracting Officer. The contract manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

Identification of Contractor Employees

All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

PART 2 DEFINITIONS & ACRONYMS

Contracting Officer’s Representative (COR) – A representative from the requiring activity assigned by the Contracting Officer to perform surveillance and to act as liaison to the Contractor.

Defective Service – A service output that does not meet the standard of performance associated with it in the Performance Work Statement.

DOL – Department of Labor

PWS – Performance Work Statement

Quality Assurance Surveillance Plan (QASP) – An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

Quality Control (QC) – Those actions taken by a contractor to control the performance of services so that they meet the requirements of the PWS.

Quality Assurance (QA) – Those actions taken by the government to assure services meet the requirements of the Performance Work Statement.

PART 3 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT,

3.1 General

Not applicable.

3.2 Equipment

Not applicable.

3.3 Services

Not applicable.

3.4 Facilities

Not applicable.

PART 4 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 General

The Contractor shall maintain a secure laboratory conducive to performing the work in this PWS. The condition of said laboratory shall be consistent with the level of security and privacy necessary to complete the tasks outline in the PWS.

4.2 Clearance

The Contracting Officer (CO) or Contracting Officer’s Representative (COR) shall exercise full and complete control over granting, withholding, or canceling clearances for contract employees, if applicable. The CO or COR may grant temporary clearances to contractor employees. However, granting a temporary clearance shall not be considered a full clearance. It also shall not prevent, preclude, or bar withdrawal or termination of any clearances by the department.

PART 5 SPECIFIC TASKS & DELIVERABLES

5.1 Basic Services

The Contractor shall provide laboratory screening of Job Corps students for drugs of abuse, Chlamydia, gonorrhea, syphilis, and HIV.

In addition, the Contractor shall provide qualified personnel, equipment and supplies, shipping, customer service, supervision, required reports, and other related items and non-personal services. The Contractor will be paid only per test, at the contract established firm fixed price per test, and for any hours spent by the Laboratory Director, Medical Review Officer and Contracts Manager for services they are required to perform under the contract.

Work Area 1 – Logistics and Administration

Labeling, Shipping, and Tracking

The Contractor shall arrange for daily pickup of specimens from centers by a nationwide, overnight courier service that guarantees delivery to the lab within 24 hours of pick-up (within 48 hours for centers located outside the continental United States). Within 30 days of contract award, the Contractor shall:

· Contact each Job Corps center and provide a comprehensive introductory training and arrange for sample collection and delivery to the lab.

· Provide necessary shipping supplies to all Job Corps centers as outlined in Work Area 2.

· Establish an ongoing technical assistance support system for all centers.

The Contractor shall provide a system to label specimens that includes Job Corps-issued student identification numbers, accession numbers, demographics (age, sex, race), center name, and test reason (e.g., entry drug test, entrance Chlamydia test, etc.).

The Contractor shall accurately track specimens throughout the shipping and analysis process using detailed event records that include steps and actions taken.

Customer Service

The Contractor shall provide a Customer Service Center that includes an administrator and back up administrator to address Job Corps center staff concerns. Initial response time shall be within 24 business hours via electronic communication and/or telephone.

Test Results

The Contractor shall provide laboratory test results to centers within timeframes outlined in Work Area 2, with the following specifications:

· Utilize a standardized template for test results.

· Report confirmed test results, including marijuana THC concentration (ng/mL) levels.

· Utilize a dedicated uniform national portal or data processing system that generates individual results and statistical and demographic analysis and reports.

· Provide a means to notify center health and wellness staff of significant findings.

· Test results shall not be provided over the phone.

Quality Control, Collaboration, and Continuing Education

The Contractor shall provide the following to ensure quality control and collaboration:

· A Job Corps-specific custody and control form and associated procedures that identify all persons who handle specimens for toxicology testing.

· A mechanism to track all specimens submitted to the laboratory.

· A feedback system that immediately notifies the COR of all issues (e.g., missing or delayed results) that are not adequately resolved through the Customer Service Center.

· A process to collaboratively and effectively resolve quality-control issues that are identified.

Where applicable, the Contractor shall provide data indicating the specificity and sensitivity of the testing methods used. The level of specificity must be at least 94%, and sensitivity must be at least 83%. In addition, the Contractor shall send at least one percent of the quality control specimens to a reference lab each month and report results to the COR.

The Contractor shall remain current in laboratory and toxicology sciences. This includes methods for testing newly abused drugs such as synthetic cannabinoids, synthetic opioids, and opioid derivatives; advances in testing for diseases included in this contract; and other relevant topics. The Contractor shall propose procedural changes that are in line with evolving standards of care.

Work Area 2 – Provide Laboratory Services, Equipment and Supplies

The Contractor shall provide laboratory services for all (currently 122) Job Corps centers. Precise identification of nanogram levels is critical so the Contractor shall use the highest level of detection available. Required laboratory services include supplying the following:

· Materials necessary for overnight shipping to meet federal, state, and local regulations for transportation of biological specimens and standards required for specimen stability (e.g., insulated packages, envelopes, tamper and leak proof transport bags with absorbent material, crush-resistant cardboard shipping containers, etc.)

· Self-adhesive labels for specimen identification

· Replacement equipment where applicable

· Supplies for necessary for specimen collection and labeling as such as those listed in the following table.

Test Examples of

Supplies Timeframes Reporting Requirements

HIV

· 50,000 4th Generation HIV tests

· 250 confirmation tests

· Sterile needles

· Vacuum tubes

· All specimens must be analyzed within 24 hours of receipt.

· If a 4th Generation test is positive, a confirmation test must be completed on the same specimen and reported to the center within 48 business hours.

Individual HIV test results shall be reported as one of the following:

· Negative 4th Generation HIV test

· Negative HIV by confirmation test

· Indeterminate HIV by confirmation test

· Positive HIV by confirmation test

Toxicology

· Approximately 60,000 10-panel drug tests in line with Job Corps procedures outlined in Toxicology Screening and Confirmation Tests and Cut-Off Levels table below

· Primarily urine collection, may use oral swab in extenuating circumstances with JCNO prior approval

· Wide mouth specimen collection cups with attached temperature strip and a lid

· Yellow top vacuum tubes

· Tamper evident/resistant seals to ensure chain of custody

· Tamper and leak proof transport bags with absorbent material

· Crush-resistant cardboard shipping containers

· All toxicology specimens shall be analyzed and reported within 24 business hours of receipt.

· All specimens that screen positive shall be confirmed by liquid chromatography/mass spectrometry (LC/MS) must be analyzed then securely and confidentially transmitted by electronic communication to the Job Corps center within 48 business hours of specimen receipt.

Confirmed positive drugs are reviewed and verified by the Medical Review Officer

Individual toxicology test results shall be reported as one of the following:

· Negative screening results for all drugs

· Confirmed positive for all drugs other than marijuana (cannabinoids)

· Creatinine Normalized THC metabolite value (reported in ng/mg) for confirmed positive marijuana (cannabinoids)

· Provide nanogram THC (ng/mL) level results for all the marijuana tests via reporting system and reporting to the OJC official.

Chlamydia and Gonorrhea · Wide-mouth · Food and Drug Individual chlamydia and

· 50,000 chlamydia tests

· 50,000 gonorrhea tests

· Collected concurrently

· Primarily urine collection, but collectors may use swabs when clinically indicated collection cups with lid

· Specimen bottles with lids

Administration-approved test using Amplified Nucleic Acid Methodology.

· Reports shall be available within 24 hours of receipt of specimen.

gonorrhea test results shall be reported as positive or negative.

Syphilis

· 50,000 syphilis screening tests

· 250 confirmatory syphilis tests

(Contractor shall specify testing based on the traditional or reverse sequence algorithm outlined by the CDC.)

· Sterile needles

· Vacuum tubes

· All specimens must be analyzed within 24 hours of receipt

· If a screening test is positive, a confirmation test must be completed on the same specimen within 48 business hours

Individual syphilis test results shall be reported based on the type of syphilis test. Contractor shall specify how the results shall be reported.

Toxicology Screening and Confirmation Tests and Cut-Off Levels

Screening Enzyme Immunoassay Cut-Off Level Marijuana (Cannabinoids) 50 ng/ml Cocaine (Benzolecgonine) 300 ng/ml Opiates 2000 ng/ml Amphetamines 1000 ng/ml Phencyclidine (PCP) 25 ng/ml Barbiturates 300 ng/ml Benzodiazepines 300 ng/ml Fentanyl 2 ng/ml Hydrocodone/Hydromorphone 300 ng/ml Oxycodone/Oxymorphone 100 ng/ml Confirmation LC/MS Cut-Off Level Creatinine Normalized THC metabolite 15 ng/ml Benzoylecgonine (Cocaine) 150 ng/ml Codeine (Opiates) 2000 ng/ml Morphine (Opiates) 2000 ng/ml Acetylmorphine (Opiates) 10 ng/ml Amphetamine (Amphetamines) 500 ng/ml Methamphetamine (Amphetamines) 500 ng/ml PCP (Phencyclidine) 25 ng/ml Barbiturates 200 ng/ml Benzodiazepines 50 ng/ml Fentanyl <1 ng/ml Hydrocodone/Hydromorphone 100 ng/ml Oxycodone/Oxymorphone 100 ng/ml

In cases of inclement weather, holidays, or other conditions that impact shipping test specimens to the contractor lab, the Contractor shall notify the COR/NOJC as soon as possible. The Contractor shall also draft written notification for centers, obtain COR/NOJC approval, and notify centers of shipping delays.

Work Area 3 – Project Management

The Contractor shall provide project management and maintain regular communication with the COR/NOJC to ensure timely and quality completion of all project deliverables. This includes, but is not limited to:

https://www.cdc.gov/std/treatment-guidelines/syphilis.htm

· Meeting with the COR/NOJC on a weekly basis, or other schedule determined by the Government, to discuss the status of deliverables and projects. The Contractor shall prepare and distribute meeting agendas as directed and submit summary notes as directed after each meeting/conference call.

· Ensuring project activities meet deadlines and are carried out efficiently.

· Complying with Job Corps’ policies and regulations (e.g., Job Corps’ Policy and Requirements Handbook, Instruction Notices, Standard Operating Procedures).

· Providing the COR/NOJC with weekly updates and submitting weekly, monthly, quarterly, year-end, and ad hoc reports as required.

· Working collaboratively with the COR/NOJC and other contractors to address and resolve crosscutting issues as needed.

Work Area 4 – Data Reports

The Contractor shall submit accurate, timely, reliable, and actionable weekly, monthly, annual, and ad hoc data reports that provide data, details, and concerns related to laboratory services provided under the awarded contract. Weekly reports are due each Monday, monthly reports are due within 20 days after the end of each month, and annual reports are due within 30 days of the end of Job Corps’ Program Year. Data must be organized in Excel, or compatible, format that allows analysis by individual student, center, type of test, and specific drug type.

HIV Data (Monthly)

· Breakdown and summary of specimens tested including positive, negative, indeterminate results.

· Breakdown and summary of specimens tested including positive, negative, indeterminate by 4th Generation HIV test, and confirmation test.

· Breakdown and summary of specimens tested by demographics (age, gender, race, center name).

· Breakdown and summary of specimens tested by region and center.

· Breakdown and summary of specimens tested monthly, by category (Entrance; Contact Exposure, including PrEP; New Sexually transmitted Infection; Clinical Indications, including PrEP; Prior Indeterminate result; Student Request).

· Breakdown and summary of specimens tested by category and reported positive, indeterminate, and negative.

Toxicology Data (Monthly)

· Breakdown and summary of students tested including positive, negative, indeterminate results.

· Breakdown and summary of students tested by region and center.

· Breakdown and summary of students tested monthly, by testing category (entrance, 45-day, suspicion, and DOT).

· Breakdown and summary of students testing positive by drug type (for THC metabolite include ng/ml levels), including national, regional, and center results.

Chlamydia Data (Monthly)

· Breakdown and summary of specimens tested including positive, negative, and indeterminate results.

· Breakdown and summary of specimens tested by demographics (age, gender, race, center name).

· Breakdown and summary of specimens tested by region and center.

· Breakdown and summary of specimens tested monthly, by category (Entrance; Reinfection 1-3 months After a Positive Test; and New Clinical Indications or Contact Exposure).

Gonorrhea Testing (Monthly)

· Breakdown and summary of specimens tested including positive, negative, and indeterminate results.

· Breakdown and summary of specimens tested by demographics (age, gender, race, center name).

· Breakdown and summary of specimens tested by region and center.

· Breakdown and summary of specimens tested monthly, by category (Entrance; Reinfection 1-3 months After a Positive Test; and New Clinical Indications or Contact Exposure).

Syphilis Testing (Monthly)

· Breakdown and summary of specimens tested including positive/reactive, negative/nonreactive, and indeterminate results.

· Breakdown and summary of specimens tested by demographics (age, gender, race, center name).

· Breakdown and summary of specimens tested by region and center.

· Breakdown and summary of specimens tested monthly, by category (Entrance exam, New Clinical Indications or Contact Exposure).

Problem Report (Monthly)

The monthly Problem Report shall summarize any problems related to collection, confidentiality, analysis of specimens, reporting results to centers, center practices, corrective actions suggested or taken, etc.

Year-to-Date Report (Yearly)

The annual year-to-date report shall include summary results by student, center, and testing category for HIV, Toxicology, Chlamydia, Gonorrhea, and Syphilis.

Technological Capabilities

The Contractor shall have a dedicated computerized and automated test request and result reporting system. At a minimum, the system will collect and report accurate, timely, reliable, and actionable results and demographic information, generate and track Job Corps issued student identification numbers and accession numbers, and track and automatically re-supply inventory. The system must be certified HIPAA compliant with internal 128-bit SSL and 3 DES encryption. The Contractor shall procure, install, and service all equipment. In addition, the Contractor shall work with the Job Corps Data Center (JCDC) on system requirements for back-end reporting and integrating test results into Job Corps’ CDSS Suite of Applications, as applicable.

The Contractor shall provide training and technical assistance to all Job Corps centers on how to operate the system. The Contractor shall have the capability to securely receive confidential inquiries from center health and wellness staff.

Centers for Disease Control

The Contractor shall provide the Centers for Disease Control (CDC), via the COR/Health and Wellness Program Manager, with pertinent statistics and test results during performance of the contract. The Contractor shall notify the COR/Health and Wellness Program Manager of any CDC requests for aliquots of positive specimens.

EDUCATION AND TRAINING

The Contractor shall provide educational and training services such as webinars, presentations, and job aids, sometimes in conjunction with Job Corps meetings. The Contractor shall also provide ongoing technical assistance to Job Corps centers to ensure specimen collection, packaging, and storage requirements are met and Job Corps center staff are trained on applicable technology.

LABORATORY QUALIFICATIONS AND KEY PERSONNEL REQUIREMENTS

The Contractor’s laboratory shall meet or exceed the following personnel and laboratory requirements:

Personnel

Technicians, Technologists, Supervisors, and Directors of the laboratory must be licensed by the state in which the tests are performed. In the absence of state licensure requirements, they must be certified by a national certifying registry such as the American Society of Clinical Pathologists (ASCP). Personnel are required to participate in continuing education programs in addition to maintaining licensure.

Key Personnel Requirements

· Laboratory Director – Doctoral degree (PhD, MD, or DO) in medical science or related field; licensed in the state in which testing is performed; 10+ years of experience in a leadership role in a clinical laboratory directing and supervising high complexity testing; extensive knowledge of CLIA, CAP, and other accreditation and regulatory requirements; excellent communication, interpersonal, and presentation skills.

· Medical Review Officer (MRO) – Doctoral degree (PhD, MD, or DO); knowledge of the pharmacology and toxicology of illicit drugs; satisfactorily passed an initial examination administered by a nationally recognized entity or subspecialty board approved to certify MROs; training necessary to serve as an MRO, specifically:

§ Knowledge of collection procedures used to collect specimens.

§ Ability to interpret laboratory test results (e.g., negative, positive, adulterated, rejected for testing, invalid, and [for urine] negative/dilute and substituted).

§ Knowledge of chain-of-custody, reporting, and recordkeeping requirements.

§ Knowledge of procedures for interpreting, reviewing, and reporting test results (e.g., investigating legitimate medical explanations, review of documentation provided by centers to support a legitimate medical explanation), and reporting of results.

§ Complete MRO requalification training, at least every 5 years, on the above topics and satisfactorily pass a requalification examination administered by a nationally recognized entity or a subspecialty board approved to certify MROs.

· Contract Manager – Bachelor’s degree in a business or financial management field; 3+ years of related contract experience;

proven quality assurance, management, and leadership skills.

Laboratory Regulatory Requirements

The Laboratory shall have a Clinical Laboratory Improvement Act (CLIA) and College of American Pathologist (CAP) licenses for testing interstate samples for Chlamydia and HIV and a Department of Health and Human Services (HHS) certification under the National Laboratory Certification Program (NLCP) to receive urine samples and test for the presence of drugs. The Laboratory shall be licensed in the state in which testing is performed and licensed in states that require licensure for testing specimens (e.g., New York, Florida, California, Pennsylvania, Maryland, and West Virginia (for HIV)). The laboratory shall be enrolled in a nationally recognized proficiency testing program such as the College of American Pathologists (CAP). In addition, the laboratory shall provide evidence of accreditation and a certificate of satisfactory performance during annual CAP inspections.

All shipments must comply with all applicable local, state, and federal laws governing packing, marking, and labeling. Blood, urine, fluids, and other specimens containing, or suspected of containing, infectious substances must be shipped according to applicable government, International Air Transport Association (IATA), and International Civil Aviation Organization (ICAO) regulations.

The Contractor shall comply with U.S. Department of Transportation (DOT) requirements related to urine toxicology testing and be certified by DOT to perform such testing. The Contractor shall offer a DOT 10-panel drug test that is consistent with Job Corps’ existing test formula.

The Contractor shall distribute phlebotomy needles in accordance with the Needlestick Safety and Prevention Act of 2001.

PART 6 APPLICABLE PUBLICATIONS

6.1 Publications Applicable to This PWS

NA

TECHNICAL EXHIBIT 1

TECHNICAL EXHIBIT 1

Performance Requirements Summary

The Contractor’s service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective Standard Performance Threshold Method of

Surveillance The Contractor shall provide laboratory screening services for HIV, Chlamydia, and Drugs of Abuse

Compliance with federal and industry regulations and policies

No more than 1 validated complaints or concerns from Federal Officials each contract year

COR

The Contractor shall provide laboratory screening supplies for HIV, Chlamydia, and Drugs of Abuse

Compliance with federal and industry regulations and policies

No more than 1 validated complaint or concern from Federal Officials each contract year

COR

The Contractor shall provide administrative and project management support

Compliance with DOL and Job Corps specific policies and requirements

No more than 1 validated complaints or concerns from Federal Officials each contract year

COR

Types of Surveillance to select from:

Random Sampling: Appropriate for frequently recurring tasks. Evaluate randomly selected samples of the lot to determine the acceptability of the entire lot.

Random Inspection Guide, Method of surveillance, Lot size, Sample size, Performance requirement, Sampling procedure, Inspection procedure.

100 Percent Inspection: Appropriate for tasks that occur infrequently. Inspect and evaluate performance each time task is performed.

Periodic Surveillance: Evaluation of samples selected on other than 100% or statistically random basis. (I.e. monthly, quarterly, semi-annually etc.)

Validated Customer Complaint: Complaints must be validated.

TECHNICAL EXHIBIT II

DELIVERABLES

Task

PWS

Deliverable Frequency Medium/Format Submit To

Task 5.1 Laboratory Screening Services for HIV, Chlamydia, Gonorrhea, Syphilis, and Drugs of Abuse Arrange for pick-up and delivery of specimens from centers as scheduled Analyze specimens and provide centers with laboratory results within timeframes noted in the PWS Provide centers with sufficient laboratory supplies and equipment Comply with Job Corps’ policies and regulations Provide weekly, monthly, quarterly, and year-end reports as required Report test results to State and local health departments for all Job Corps centers as required per state and federal mandates

As Directed Supplies Centers

Administrative and Project Management

Provide Administrative and Project Management Support

Participate in regular meetings with Job Corps staff and/or contractors as necessary and provide meeting agendas and notes Ensure lab results and project activities are carried out efficiently and meet deadlines Provide training and technical support Comply with Job Corps policies and regulations Provide weekly status updates and submit weekly, monthly, quarterly, year-end, and ad hoc reports as required

Ongoing COR

ACCEPTANCE OF DELIVERABLES

The Government shall accept or reject deliverables by giving written notice. In the event of rejection of any deliverable, the COR, giving the specific reason(s) for the rejection shall notify the Contractor in writing. The Contractor shall correct the rejected deliverable and return it to the COR within the number of days specified in the written notification.

D - CONTRACT CLAUSES

FAR Clauses

52.202-1 Definitions. (JUN 2020)

52.203-6 Restrictions on Subcontractor Sales to the Government. (JUN 2020) - Alternate I (NOV 2021)

52.203-12 Limitation on Payments to Influence Certain Federal Transactions. (JUN 2020)

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper. (MAY 2011)

52.204-19 Incorporation by Reference of Representations and Certifications. (DEC 2014)

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021)

52.212-1 Instructions to Offerors - Commercial Products and Commercial Services. (SEP 2023)

52.212-4 Contract Terms and Conditions - Commercial Products and Commercial Services. (NOV 2023) - Alternate I (NOV 2021)

(a) Inspection/Acceptance. (1) The Government has the right to inspect and test all materials furnished and services performed under this contract, to the extent practicable at all places and times, including the period of performance, and in any event before acceptance.