TB Lab Testing Services Solicitation 75D301-20-R-67962 FINAL.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

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

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 65

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-20-R-67962

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

06/30/2020

6. REQUISITION/PURCHASE NO.

00HCVJED-2020-43166

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7) Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________ NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

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 2:00p local time 07/30/2020

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Denedra Threatt

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(404) 498-3371

C. E-MAIL ADDRESS

dthreatt2@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 34

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 9 X J LIST OF ATTACHMENTS 45

X D PACKAGING AND MARKING 17 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 18 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 19 X K OTHER STATEMENTS OF OFFERORS 45

X G CONTRACT ADMINISTRATION DATA 20 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 52

X H SPECIAL CONTRACT REQUIREMENTS 24 X M EVALUATION FACTORS FOR AWARD 60

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. 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.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILIT

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

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

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434 Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta GA 30341 4004

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta GA 30333 0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD 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 STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section B - Supplies Or Services And Prices/Costs

B.1 LINE ITEMS

Base Year: Period of Performance: September 25, 2020 – September 24, 2021

ITEM SUPPLIES/SERVICES QTY/UNIT UNIT PRICE EXTENDED

PRICE

0001 Tuberculosis Laboratory Testing for the U.S.-affiliated Pacific Islands

This is a firm-fixed price line item.

This is a severable line item.

1 Job

0002 Travel: Site/Training Visits

This is a Cost Reimbursable line item in accordance with Federal Travel Regulations.

This is a severable line item.

1 Job NOT TO EXCEED

0003 Travel: Pacific Islands TB Controllers Association (PITCA) Conference attendance

This is an optional unfunded cost reimbursable CLIN.

IMPORTANT NOTE: Any and all travel as it pertains to conferences, or other items, including labor hours, in support of conferences, must be entered in the Integrated Conference Approval Portal (ICAP) and approved at all required levels prior to the funds being obligated for the conference attendance.

Contractor shall verify with the COR/CO that ICAP approval was obtained prior to incurring any costs related to travel/conferences. The COR shall verify that ICAP approval was obtained prior to paying any invoices with costs related to conferences.

1 Job NOT TO EXCEED

Option Year 1: Period of Performance: September 25, 2021 – September 24, 2022

1001 Tuberculosis Laboratory Testing for the U.S.-affiliated Pacific Islands

This is a firm-fixed price line item.

This is a severable line item.

1 Job

1002 Travel: Site/Training Visits

This is a cost reimbursable line item in accordance with Federal Travel Regulations.

This is a severable line item.

1 Job NOT TO EXCEED

1003 Travel: Pacific Islands TB Controllers Association (PITCA) Conference attendance

This is an optional unfunded cost reimbursable CLIN.

IMPORTANT NOTE: Any and all travel as it pertains to conferences, or other items, including labor hours, in support of conferences, must be entered in the Integrated Conference Approval Portal (ICAP) and approved at all required levels prior to the funds being obligated for the conference attendance.

Contractor shall verify with the COR/CO that ICAP approval was obtained prior to incurring any costs related to travel/conferences. The COR shall verify that ICAP approval was obtained prior to paying any invoices with costs related to

Option Year 2: Period of Performance: September 25, 2022 – September 24, 2023

2001 Tuberculosis Laboratory Testing for the U.S.-affiliated Pacific Islands

1 Job

This is a firm-fixed price line item.

This is a severable line item.

2002 Travel: Site/Training Visits

This is a cost reimbursable line item in accordance with Federal Travel Regulations.

This is a severable line item.

1 Job NOT TO EXCEED

2003 Travel: Pacific Islands TB Controllers Association (PITCA) Conference attendance

This is an optional unfunded cost reimbursable CLIN.

IMPORTANT NOTE: Any and all travel as it pertains to conferences, or other items, including labor hours, in support of conferences, must be entered in the Integrated Conference Approval Portal (ICAP) and approved at all required levels prior to the funds being obligated for the conference attendance.

Contractor shall verify with the COR/CO that ICAP approval was obtained prior to incurring any costs related to travel/conferences. The COR shall verify that ICAP approval was obtained prior to paying any invoices with costs related to

Option Year 3: Period of Performance: September 25, 2023 – September 24, 2024

3001 Tuberculosis Laboratory Testing for the U.S.-affiliated Pacific Islands

This is a firm-fixed price line item.

This is a severable line item.

1 Job

3002 Travel: Site/Training Visits

This is a cost reimbursable line item in accordance with Federal Travel Regulations.

This is a severable line item.

3003 Travel: Pacific Islands TB Controllers Association (PITCA) Conference attendance

This is an optional unfunded cost reimbursable CLIN.

IMPORTANT NOTE: Any and all travel as it pertains to conferences, or other items, including labor hours, in support of conferences, must be entered in the Integrated Conference Approval Portal (ICAP) and approved at all required levels prior to the funds being obligated for the conference attendance.

Contractor shall verify with the COR/CO that ICAP approval was obtained prior to incurring any costs related to travel/conferences. The COR shall verify that ICAP approval was obtained prior to paying any invoices with costs related to

Option Year 4: Period of Performance: September 25, 2024 – September 24, 2025

4001 Tuberculosis Laboratory Testing for the U.S.-affiliated Pacific Islands

This is a firm-fixed price line item.

This is a severable line item.

1 Job

4002 Travel: Site/Training Visits

This is a cost reimbursable line item in accordance with Federal Travel Regulations.

This is a severable line item.

1 Job NOT TO EXCEED

4003 Travel: Pacific Islands TB Controllers Association (PITCA) Conference attendance

This is an optional unfunded cost reimbursable CLIN.

IMPORTANT NOTE: Any and all travel as it pertains to conferences, or other items, including labor hours, in support of conferences, must be entered in the Integrated Conference Approval Portal (ICAP) and approved at all required levels prior to the funds being obligated for the conference attendance.

Contractor shall verify with the COR/CO that ICAP approval was obtained prior to incurring any costs related to travel/conferences. The COR shall verify that ICAP approval was obtained prior to paying any invoices with costs related to

B.2 TRAVEL CLINs AND OPTIONAL TRAVEL CLINs

Travel CLINs 0002, 1002, 2002, 3002, 4002 may be utilized multiple times during a performance period but shall not cumulatively exceed the Not-to-Exceed Amount awarded for that period of performance.

Annual travel is estimated for each of these Optional CLINs in an amount not to exceed the amount negotiated at time of award.

OPTIONAL TRAVEL CLINS 0003, 1003, 2003, 3003, 4003 may be utilized for Conference, Meeting and related Travel Costs. The Performance Work Statement (PWS) includes tasks that may require the Contractor to attend conferences or meetings or travel to successfully perform the work. If the Government determines there is a need for travel to support the work under the PWS, the Program Office will define the required travel and submit other required documentation to obtain the ICAP approval, if conference or conference-related travel is required. Upon receipt of required approvals, funding and documentation that describes the travel requested, the Contracting Officer will exercise the option for Optional Travel after providing written notification to the Contractor. The notification will state the purpose of the travel and define the required travel that the Contractor is required to take. The Contractor will review the defined travel required and provide a price estimate to the Government, which the Government will evaluate. After that written notification and process concludes with an agreed upon and approved price for the travel, a funded, unilateral modification will be issued to exercise the option or options. The Contracting Officer may choose to issue a bilateral modification.

The Government reserves the right not to exercise the option for the Optional CLINs during the performance of this contract. The Government may elect to exercise some of the Optional Travel CLINS and not others. Such election having no impact or effect upon the Government’s right or ability to exercise any other optional CLIN.

*Travel billed at cost “Travel will be billed at actual cost and in accordance with Federal Travel regulations located at https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation-ftr

B.3 SCHEDULE OF MILESTONES FOR PAYMENTS

In accordance with FAR 52.232-32, upon successful completion of a milestone event, the contractor may request performance based payments. The offeror shall propose the milestone payment chart. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the COR that the performance milestone has been met. It is anticipated that each milestone payment will approximate the proposed timeline but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone.

The COR receiving and acceptance of performance based payments is based on verification that work on the contract was satisfactorily performed during the month and that, at a minumum, the following laboratory services and activities were satisfactorily performed:

1. AFB smear microscopy, culture, and identification of M. tuberculosis complex.

2. Identification of non-tuberculous mycobacteria (NTM) when defined criteria are met.

3. Nucleic acid amplification testing, molecular testing, or other rapid tests for direct detection of M. tuberculosis.

4. Phenotypic (i.e., growth-based) drug susceptibility testing (DST) on isolates of M.

tuberculosis and molecular drug susceptibility testing.

5. Submission of M. tuberculosis isolates for Genotyping.

6. Reporting and storing results using a web-based electronic laboratory information system.

7. Reporting of critical value test results.

8. Providing laboratory consultation, technical assistance, and interpretation of results.

9. Archive isolates in appropriate refrigerated storage areas.

10. Provide written notification to the COR when there are changes to shipping regulations, guidelines, and/or procedures.

11. Provide updated written procedures to the COR when there are changes made to shipping regulations, guidelines, and/or procedures.

12. Provide training records to the COR for any trainings delivered.

13. Submission of monthly workload and monthly line list reports.

The final milestone payment schedule will be negotiated between the Government and the Contractor and included in the contract award. The offeror may propose the milestone payment chart based on the deliverable schedule and /or other milestone events as identified by the offeror. The proposed milestone payment schedule shall be backloaded. The offeror shall propose the milestone payment chart below:

Base Period Milestone Schedule

MILESTONE DATE PAYMENT

DURATION

PAYMENT

AMOUNT

October (Period of Performance beginning 9/25/2020)

10/25/2020 1 Month

November 11/25/2020 1 Month

December 12/25/2020 1 Month

January 1/25/2021 1 Month

February 2/25/2021 1 Month

March 3/25/2021 1 Month

April 4/25/2021 1 Month

May 5/25/2021 1 Month

June 6/25/2021 1 Month

July 7/25/2021 1 Month

August 8/25/2021 1 Month

September 9/25/2021 1 Month

Total $

Option Period 1 Milestone Schedule

MILESTONE DATE PAYMENT

DURATION

PAYMENT

AMOUNT

October (Period of Performance beginning 9/25/2021)

10/25/2021 1 Month

November 11/25/2021 1 Month

December 12/25/2021 1 Month

January 1/25/2022 1 Month

February 2/25/2022 1 Month

March 3/25/2022 1 Month

April 4/25/2022 1 Month

May 5/25/2022 1 Month

June 6/25/2022 1 Month

July 7/25/2022 1 Month

August 8/25/2022 1 Month

September 9/25/2022 1 Month

Total $

Option Period 3 Milestone Schedule

MILESTONE DATE PAYMENT

DURATION

PAYMENT

AMOUNT

October (Period of Performance beginning 9/25/2022)

10/25/2022 1 Month

November 11/25/2022 1 Month

December 12/25/2022 1 Month

January 1/25/2023 1 Month

February 2/25/2023 1 Month

March 3/25/2023 1 Month

April 4/25/2023 1 Month

May 5/25/2023 1 Month

June 6/25/2023 1 Month

July 7/25/2023 1 Month

August 8/25/2023 1 Month

September 9/25/2023 1 Month

Total $

Option Period 4 Milestone Schedule

MILESTONE DATE PAYMENT

DURATION

PAYMENT

AMOUNT

October (Period of Performance beginning 9/25/2023)

10/25/2023 1 Month

November 11/25/2023 1 Month

December 12/25/2023 1 Month

January 1/25/2024 1 Month

February 2/25/2024 1 Month

March 3/25/2024 1 Month

April 4/25/2024 1 Month

May 5/25/2024 1 Month

June 6/25/2024 1 Month

July 7/25/2024 1 Month

August 8/25/2024 1 Month

September 9/25/2024 1 Month

Total $

Section C - Description/Specification/Work Statement

PERFORMANCE WORK STATEMENT

PROJECT TITLE: Tuberculosis Laboratory Services for the U.S.-Affiliated Pacific Islands

SECTION 1 –BACKGROUND

The United States (U.S.) prevention and control agenda for the Centers for Disease Control and Prevention (CDC) Division of Tuberculosis (TB) Elimination includes the 50 states, Washington, D.C., Puerto Rico, U.S. Virgin Islands, and six U.S.-Affiliated Pacific Islands (USAPI). The USAPI includes three U.S. Territories – American Samoa, the Commonwealth of the Northern Mariana Islands (CNMI), Guam, and three Freely Associated States (FAS) – the Federated States of Micronesia (FSM), the Republic of the Marshall Islands (RMI), and the Republic of Palau. The FAS have a Compact of Free Association with the U.S. Under the compact, these nations are fully sovereign in domestic and foreign affairs, but the U.S. is responsible for their health, education, defense, and other essential operations to the United States. TB incidence rates across the USAPI are high and residents of these jurisdictions have the right to travel to the U.S. without a visa and are not required to complete a medical examination to screen for TB prior to arrival.

As indicated in the Essential Components of a Tuberculosis Prevention and Control Program (1), one of the core components for effective TB control programs is the delivery of laboratory and diagnostic services, as well as the need to collect and analyze data. Through extensive technical assistance and laboratory assessments, CDC has identified that laboratories throughout the USAPI are unable to fulfill this essential program activity. The public health laboratories in the USAPI conduct limited TB testing and lack the capacity and expertise to provide comprehensive services needed to detect and identify Mycobacterium tuberculosis.

SECTION 2 – PURPOSE

Provide CDC promulgated TB laboratory services to the USAPI to improve TB control and prevention.

This contract will support CDC’s mission to fight disease before it reaches our borders by providing the USAPI with TB laboratory test results and training needed to accurately diagnose TB patients and prescribe appropriate medication. CDC will also use results to provide medical consultation and technical assistance to the USAPI TB programs.

SECTION 3 – SCOPE OF WORK

The Contractor’s facility and the Contractor shall, as an independent organization and not as an agent of the U.S. Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities to perform the services required in the contract. Travel is required and outlined in SECTION 4.

The Contractor shall perform the tasks outlined in SECTION 4 for the TB control programs and their designated TB laboratory in the following ten USAPI locations: 1) American Samoa; 2) CNMI; 3) Guam; 4) Chuuk State, 5) Kosrae State, 6) Pohnpei State, and 7) Yap State in the FSM; 8) Ebeye and 9) Majuro in the RMI; and in the 10) Republic of Palau.

The performance period will include a base period of one-year (12 months) in duration followed by four one-year (12 month) option periods. The total performance period will be for a total of five years (60 months) if all options are exercised.

SECTION 4 – TASKS TO BE PERFORMED

The contractor shall perform the following tasks:

Task 1.0 – Specimen Transport Establish and implement an airline and land courier logistical process to pack, ship, and receive TB specimens from the ten USAPI TB laboratories to the Contractor on a schedule that allows for timely processing.

Subtask 1.1 – Provision of Specimen Collection and Packaging Supplies Provide all specimen collection and packaging supplies which include, but not limited to, collection containers, Sputocol™ sputum collection system, substances for neutralization of gastric aspirates, leak-proof specimen bags, absorbent material, Styrofoam containers, UN (United Nations) approved boxes, packaging tape, mailing labels, and shippers declaration forms.

Fulfill requests for supplies within five business days of receipt. Develop and provide written procedures for the following:

• Requesting specimen collection and packaging supplies

• Using the Sputocol™ sputum collection system

• Using substances for neutralization of gastric aspirates

• Packaging specimens for shipment that includes appropriate illustrations for various packaging steps

Subtask 1.2 – Shipping of Specimens Develop and provide written procedures for shipping specimens from each of the ten USAPI TB laboratories to the Contractor. The procedures shall adhere to all regulations and/or guidelines established by the U.S. Department of Transportation (DOT), Federal Aviation Administration (FAA), and International Air Transportation Association (IATA). The procedure shall outline steps for delivering shipment to the local carrier in the USAPI site, ensuring appropriate temperature controls based on flight duration, obtaining clearance at the destination airport, ensuring appropriate temperature controls at the destination airport if timely delivery to the Contractor cannot be made, and transportation from the destination airport to the Contractor. In the event of changes to regulations, guidelines, and/or procedures, the Contractor shall provide written notification to the USAPI sites and the Contracting Officer’s Representative (COR) within 48 hours and shall provide an updated written procedure within five business days.

Task 2.0 – Laboratory Testing Provide smear microscopy and culture for acid-fast bacilli (AFB), identification of M. tuberculosis and non-tuberculous mycobacteria, direct detection, and drug susceptibility testing on samples submitted from the USAPI sites. Ensure that testing algorithms for the USAPI established by CDC are followed. The Contractor shall process up to 4,500 specimens each contract period. The COR will determine the number of specimens to process each contract period.

Subtask 2.1 – Smear Microscopy and Culture for AFB and Identification Perform AFB smear microscopy, culture, and identification of M. tuberculosis complex by using conventional and rapid methodologies described in published guidelines cited in Section 6.

Reference Materials (2,3,4,5,9). Perform identification of non-tuberculous mycobacteria (NTM) only when all of the following criteria are met: 1) the Contractor has data that demonstrates the isolate is not part of the M. tuberculosis complex, 2) there is clinical suspicion that NTM is the cause of infection, 3) the USAPI site requests NTM identification, and 4) a written request is submitted to CDC and approved.

Subtask 2.2 – Direct Detection Perform nucleic acid amplification testing, molecular testing, or other rapid tests for direct detection of M. tuberculosis using validated and established procedures described in published guidelines cited in Section 6. Reference Materials (2,5,6,9).

Subtask 2.3 – Drug Susceptibility Testing

• Perform phenotypic (i.e., growth-based) drug susceptibility testing (DST) on isolates of M.

tuberculosis using validated and established procedures described in published guidelines cited in Section 6. Reference Materials (3,6,7,9). The DST panel shall include the four first-line anti-tuberculosis drugs: 1) isoniazid, 2) rifampin, 3) pyrazinamide, and 4) ethambutol.

• Perform DST of second-line anti-tuberculosis drugs and molecular drug susceptibility testing when requested by the submitting USAPI site and in accordance with testing algorithms established by CDC. The testing panel for second-line DST shall include at least one fluoroquinolone, amikacin, capreomycin, and kanamycin.

• Use of a reference laboratory for DST is acceptable and may be necessary to obtain DST for new and repurposed drugs that might be used as part of treatment regimens, especially for drug resistant cases. The Contractor shall describe the criteria to determine which isolates will be sent to the reference laboratory, the name of the reference laboratory, testing methods, DST panel, and anticipated turnaround times. Consideration should be given to use of the CDC Division of TB Elimination Reference Laboratory for samples from the USAPI that require expanded DST.

• Submit samples to CDC for Molecular Detection of Drug Resistance testing when resistance to rifampin is detected by either molecular or phenotypic methods, when requested by the USAPI site, and in accordance with testing algorithms established by

CDC.

Subtask 2.4 – Submission for Genotyping Ship at least one M. tuberculosis isolate from each culture-positive TB patient to the public health laboratory in the state of the Contractor for submission to the laboratory contracted by CDC to conduct genotyping.

Task 3.0 – Reporting and Storing Results Follow the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and HIPAA Privacy & Security Rules to ensure the protection and confidentiality of individually identifiable health information while completing the following subtasks:

Subtask 3.1 – Reporting and Storing Results Results shall be reported through a web-based electronic laboratory information system within 24 hours after results are known. Provide USAPI sites, the COR, and COR designees with access to the system to retrieve results and written instructions on how to operate the system. Provide the COR with a list of all user who have access to the system. Verify this list annually and add or remove user access when requested by the USAPI sites, the COR, and COR designees.

Subtask 3.2 – Reporting of Critical Value Test Results

Notify specimen submitters of critical value test results via e-mail within 24 hours after results are known. Critical value test results include: AFB smear-positive, culture identification of M.

tuberculosis complex, direct detection of M. tuberculosis, and detection of any drug resistance.

Subtask 3.3 – Workload Report

• Submit a monthly quantitative workload report that contains:

1) The number of specimens processed for each of the ten USAPI TB laboratories

2) The cumulative number of specimens processed during the base and option periods.

• Submit a final quantitative workload report that contains:

1) The number of specimens processed for each of the ten USAPI TB laboratories by base and option periods.

2) The number of specimens processed by base and option periods.

3) The number of specimens processed during the entire performance period.

Subtask 3.4 – Line List Report Submit a monthly line list report that contains, at a minimum, the following variables for all specimens received and processed from each of the ten USAPI TB laboratories:

• Accession number and patient identification number.

• Specimen collection date, receiving date, specimen source or type (e.g., sputum, gastric lavage, or pleural fluid), number in series collected (e.g., 1 of 3), category (diagnostic or follow-up), volume (milliliter), and consistency (mucoid or salivary).

• USAPI smear result, smear count, and Xpert MTB/RIF (or equivalent) results.

• Contractor laboratory smear result, smear count, culture, DST, overgrowth, and any molecular results, as applicable.

Task 4.0 – Laboratory Consultation The Contractor shall be available for consultation by phone and email to the ten USAPI TB laboratory and TB control program staff for technical assistance and interpretation of results.

Task 5.0 – Specimen Storage Archive isolates in appropriate refrigerated storage areas for the duration of this contract. Safely and legally destroy isolates at the expiration of this contract only after verifying that at least one isolate from each culture-positive TB patient has been submitted for genotyping.

Task 6.0 – Coordination and Facilitation of Conference Calls Coordinate and facilitate conference calls to share information, develop plans, provide clarity, discuss issues, identify solutions, and make decisions in conjunction with the COR. There shall be monthly conference calls that include the Contractor and CDC. There shall be quarterly conference calls that include the Contractor, CDC, and the laboratory managers and technicians from the ten USAPI TB laboratories. The Contractor shall provide the conference call line that will be used, develop the agendas, take notes during the calls, and email minutes to all participants within 3 business days after the calls.

Task 7.0 – Laboratory Quality Assurance The following subtasks shall be completed by the Contractor:

Subtask 7.1 – Development of a TB Laboratory Quality Assurance Plan Develop a laboratory quality assurance (QA) plan as described in published guidelines cited in Section 6. Reference Materials (2,3,4,8,9) that will be used to monitor the ten USAPI TB laboratories to ensure consistency and measure improvement in delivering accurate local AFB-smear microscopy results and molecular results, as applicable. The plan shall include external quality assessment (EQA) protocols for using proficiency testing panels, blinded slide rechecking, and nucleic acid amplification testing (e.g., Xpert MTB/RIF Assay). Disseminate the laboratory QA plan and EQA protocol to the COR and the ten USAPI TB laboratories.

Subtask 7.2 – Implementation and Monitoring Implement the laboratory QA plan within 60 calendar days after contract award and conduct EQA during the base period and each option period. The Contractor shall provide all materials needed for the ten USAPI TB laboratories to complete the EQA.

Subtask 7.3 – Reporting Outcomes Develop and submit a report that summarizes the results of all activities that are part of the laboratory QA plan within 10 business days of completing the EQA.

Task 8.0 – Site Visits to USAPI TB Laboratories Conduct a site visit to each USAPI TB laboratory every 24–30 months. Conduct at least five site visits in the base period, and five in each option period. Site visits shall be a minimum duration of one business day. The Contractor and COR will identify the USAPI TB laboratories that will receive a site visit during the base and option periods. The Contractor shall communicate directly with each USAPI TB laboratory to coordinate site visits and provide the COR with a list of the dates and locations of scheduled site visits.

Travel to conduct site visits shall be in accordance with the Federal Travel Regulation. The Contractor shall not travel without approval from the COR. The Contractor shall plan travel so that at least two site visits are completed before returning home, and no more than three round trips are traveled each base and option period.

During site vists, the Contractor shall provide technical assistance, evaluate staff capabilities, and assess operations, equipment, and safety using an assessment tool comparable to the resource published by the Association of Public Health Laboratories and cited in Section 6. Reference Materials (9). Within 30 calendar days of returning from a site visit, submit a written report containing the following elements:

• Location, dates, and times of site visit

• Site visit objectives

• Name and position title of key persons met

• Key findings

• Recommendations

• Action items and timelines for completion

• Method for measuring completion of action items

Task 9.0 – Training of USAPI TB Laboratory Staff Deliver web-based trainings to address knowledge gaps when a need is identified. In-person trainings shall only be delivered during site visits. The Contractor shall provide all training materials (e.g., PowerPoint slides and handouts) to the COR for review 3 weeks before the training takes place. Create a training record that includes the jurisdiction name, training date, topic, names of training participants, test scores (pre and post), and training evaluation results. Training records shall be submitted to the COR within 30 calendar days after the training.

Task 10.0 – Participate in Planning the Pacific Islands TB Controllers Association (PITCA) Conference

Serve on the planning committee for the annual PITCA conference to help inform laboratory topics for the plenary session agenda. Also, lead the coordination and development of the agenda for the laboratory breakout session agenda. The laboratory breakout session shall focus on addressing training and education needs identified during site visits and include some of the following topics:

• Direct AFB smear microscopy with Ziehl-Neelsen (ZN) stain (i.e., preparing, staining, and reading AFB slides)

• GeneXpert MTB/RIF direct detection or equivalent molecular assay

• Collecting quality specimens (i.e., sputum vs. saliva)

• Recording results and submitting complete documentation with specimen to the Contractor

• Updates on packing and shipping procedures based on current DOT, FAA, and IATA guidelines

• Feedback on results of laboratory testing from jurisdictional samples and EQA

• Developing TB laboratory testing manuals that align with principles of a functioning quality management system

Task 11.0 – Travel to Participate in the PITCA Conference Travel to the PITCA Conference to serve as faculty, present a summary of the services the Contractor provided, present on TB laboratory topics, and facilitate the laboratory breakout session. The PITCA Conference is typically a 5-day event that occurs annually in November. NOTE: Travel is contingent on CDC approval of the PITCA conference in the Integrated Conference Approval Portal (ICAP).

Task 12.0 – Post-Award Kickoff Meeting Host a one-day post-award kickoff meeting at the Contractor’s facility within 2 weeks after contract award that will be attended by the CO/CS, COR, and representatives from the CDC Division of TB Elimination. The meeting shall include a discussion of the contract requirements and a tour of the Contractor’s facility. The Contractor shall develop the agenda with input from the COR, take notes during the meeting, and email a summary of the notes to all participants within 3 business days after the meeting.

SECTION 5 – QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) / PERFORMANCE-

BASED MATRIX

Performance Objective and Description Performance Standard Acceptable

Quality Level Surveillance

Method Incentive and Disincentive

Overall Contract Management Provides and maintains services that are of high quality, reliable, timely, and complete.

Tasks are completed in a professional manner and within acceptable levels and timeframes agreed upon between the Contractor and CO.

CO and COR receives no more than 4 valid complaints per base and option period.

Feedback from

USAPI TB

laboratory and TB control program staff

Incentive: Full payment in accordance with performance-based payment schedule and a positive performance evaluation

Disincentive: Withholding of payment in accordance with performance-based payment schedule and a negative performance evaluation

Invoice Management Submits timely and accurate invoices.

Invoices are submitted for payment within 60 days after the end of every month.

Invoices contain correct and accurate information, are properly formatted, and only contain allowable costs.

No invoices are submitted beyond 60 days after the end of every month.

No invoices require suspension or disallowance due to mistakes, incompleteness, or unallowable costs.

Review and acceptance by CO and COR.

Incentive: Full payment in accordance with performance-based payment schedule and a positive performance evaluation

Disincentive: Withholding of payment in accordance with performance-based payment schedule and a negative performance evaluation

Contractor Responsiveness Responds to questions and/or concerns from USAPI TB laboratory, TB control program staff, CO, or COR.

Response time is within 24–48 hours depending on the urgency and complexity.

CO and COR receives no more than 4 valid complaints per base and option period.

Feedback from

USAPI TB

laboratory and TB control program staff.

CO and COR monitoring.

Incentive: Full payment in accordance with performance-based payment schedule and a positive performance evaluation

Disincentive: Withholding of payment in accordance with performance-based payment schedule and a negative performance evaluation

Laboratory Testing

Complete, timely, and accurate products and services in accordance with the Contractor’s quality control plan, professional scientific standards, and industry standards.

95% Evaluated by COR or designee.

Incentive: Full payment in accordance with performance-based payment schedule and a positive performance evaluation

Disincentive: Withholding of payment in accordance with performance-based payment schedule and a negative performance evaluation

Completion of Deliverables

Deliverables are completed within the timeframes specified.

95% Review and acceptance by

COR.

Incentive: Full payment in accordance with performance-based payment schedule and a positive performance evaluation

Disincentive: Withholding of payment in accordance with performance-based payment schedule and a negative performance evaluation

Submission of Reports

Reports of high quality, fully edited, and accurate are submitted prior to the due dates.

95% Review and acceptance by

COR.

Incentive: Full payment in accordance with performance-based payment schedule and a positive performance evaluation

Disincentive: Withholding of payment in accordance with performance-based payment schedule and a negative performance evaluation

SECTION 6 – REFERENCE MATERIALS

1. CDC. Essential components of a tuberculosis prevention and control program. Recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1995;44(No. RR-11):1–16.

Available at http://www.cdc.gov/mmwr/pdf/rr/rr4411.pdf

2. Clinical and Laboratory Standards Institute (CLSI). Laboratory Detection and Identification of Mycobacteria; 2nd Ed. CLSI guideline M48. 2018, Wayne, Pennsylvania.

3. Kent, P.T. and G. P. Kubica, 1985. Public Health Mycobacteriology: A guide for the level III laboratory. Atlanta: Department of Health and Human Services.

4. World Health Organization. Quality Assurance of Sputum Microscopy in DOTS Programmes. Manila, Philippines: Regional Office for the Western Pacific, WHO; 2003. Available at http://www.who.int/ihr/training/laboratory_quality/11_cd_rom_tb_eqa_wpro.pdf

5. CDC. Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis. Atlanta, GA: US Department of Health and Human Services, CDC; 2009. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm

6. CDC. Availability of an Assay for Detecting Mycobacterium tuberculosis, Including Rifampin- Resistant Strains, and Considerations for Its Use—United States, 2013. Atlanta, GA: US Department of Health and Human Services, CDC; 2013. Available at https://www.cdc.gov/mmwr/pdf/wk/mm6241.pdf

7. Clinical and Laboratory Standards Institute (CLSI). Susceptibility Testing of Mycobacteria, Norcardiae spp, and Other Aerobic Actinomycetes, in 3rd Ed. CLSI Standard M24. 2018, Wayne, Pennsylvania.

8. CDC. National Plan for Reliable Tuberculosis Laboratory Services Using a Systems Approach.

Atlanta, GA: US Department of Health and Human Services, CDC; 2002. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5406a1.htm

9. Association of Public Health Laboratories. Mycobacterium tuberculosis: Assessing Your Laboratory.

2019. Silver Spring, MD. Available at https://www.aphl.org/aboutAPHL/publications/Documents/ID- 2019Apr-TB-Toolkit.pdf

SECTION 7 – PLACE OF PERFORMANCE

The Contractor shall perform all work under this contract at the contractor’s facility.

http://www.cdc.gov/mmwr/pdf/rr/rr4411.pdf http://www.who.int/ihr/training/laboratory_quality/11_cd_rom_tb_eqa_wpro.pdf http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm https://www.cdc.gov/mmwr/pdf/wk/mm6241.pdf http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5406a1.htm https://www.aphl.org/aboutAPHL/publications/Documents/ID-2019Apr-TB-Toolkit.pdf https://www.aphl.org/aboutAPHL/publications/Documents/ID-2019Apr-TB-Toolkit.pdf

Section D - Packaging And Marking

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

Section E - Inspection And Acceptance

E.1

FAR SOURCE TITLE AND DATE

52.246-4 Inspection of Services - Fixed-Price (Aug 1996)

E.2 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative [who for the purposes of this contract shall be the Contracting Officer’s Representative (COR)] at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance

F.1

52.242-15 Stop-Work Order (Aug 1989)

52.242-17 Government Delay of Work (Apr 1984)

F.2 Deliverables

Item No.

Task / Subtask Description Due Date Method Recipient

1 1.1 1.2

Written procedures for the following:

• Requesting specimen collection and packaging supplies

• Using the Sputocol™ sputum collection system

• Using substances for neutralization of gastric aspirates

• Packaging specimens for shipment that includes appropriate illustrations for various packaging steps

• Shipping specimens from each of the ten USAPI TB laboratories to the Contractor

10 business days after contract award Email COR

2 1.2 Written notification when there are changes to shipping regulations, guidelines, and/or procedures.

48 hours of the change Email COR

3 1.2

Updated written procedures when there are changes made to shipping regulations, guidelines, and/or procedures.

3 business days of the notification of the change Email COR

4 3.1 Written instructions on how to operate the web-based electronic information system to retrieve laboratory results.

10 business days after contract award Email COR

5 3.1

Written list of all persons who have access to the web-based based electronic information system and verify this list annually.

10 business days after contract award and 10 business days after the start of each option period

Email COR

6 3.3

Monthly workload report that summarizes the number of specimens received and processed from each of the ten USAPI TB laboratories and a cumulative account of the total

15th of each month Email COR number of specimens processed during the base and option periods.

7 3.4

Monthly line list report for all specimens received and processed from each of the ten USAPI TB laboratories.

15th of each month Email COR

8 6.0

Agendas for monthly conference calls between the Contractor and CDC, and quarterly conference calls that include Contractor, CDC, and the laboratory managers and technicians from the ten USAPI TB laboratories.

3 business days prior to the calls Email COR

9 6.0

Minutes of monthly conference calls between the Contractor and CDC, and quarterly conference calls that include Contractor, CDC, and the laboratory managers and technicians from the ten USAPI TB laboratories.

3 business days after the calls Email COR

10 7.1

Written TB laboratory QA plan that will be used to monitor the ten USAPI TB laboratories to ensure consistency and measure improvement in delivering accurate local AFB-smear microscopy results and molecular results, as applicable.

30 calendar days after contract award Email COR

11 7.3

Written report of the EQA that summarizes the results of all activities that are part of the laboratory QA plan.

10 business days after completion of the EQA Email COR

12 8.0 List of dates and locations of scheduled site visits.

30 calendar days after contract award and 30 calendar days after the start of each option period

Email COR

13 8.0 Written site visit report. 30 calendar days after completing a site visit Email COR

14 9.0 Training records. 30 calendar days after the training Email COR

15 12.0 Agenda for post-award kickoff meeting.

3 business days prior to the meeting Email COR

16 12.0 Summary of notes from post-award kickoff meeting.

3 business days after the meeting. Email COR

Section G - Contract Administration Data

G.1 Contract Representative

Contracting Officer (CO) responsible for this contract:

Sherrie N. Randall Centers for Disease Control and Prevention (CDC) Office of Financial Resources (OFR) Office of Acquisition Services (OAS) 2900 Woodcock Blvd. (TCU-4) Atlanta, GA 30341 Phone: (770) 488-2866 Email: iom2@cdc.gov

Contract Specialist (CS) responsible for this contract:

Denedra D. Threatt Centers for Disease Control and Prevention (CDC) Office of Financial Resources (OFR) Office of Acquisition Services (OAS) 2900 Woodcock Blvd. (TCU-4) Atlanta, GA 30341 Phone: (404) 498-3371 Email: Dthreatt2@cdc.gov

Contracting Officer’s Representative (COR) responsible for this contract: TBD

G.2 CDCA_G001 – Invoice Submission (Jul 2017)

(a) The Contractor shall submit the original contract invoice/voucher to the address shown below:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333

Or – The Contractor may submit the original invoice via facsimile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall submit 2 copies of the invoice to the cognizant contracting office previously identified in this contract. These invoice copies shall be addressed to the attention of the Contracting Officer.

(c) The Contractor is , is not required to submit a copy of each invoice directly to the Contracting Officer’s Representative (COR) concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Office of Financial Resources is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c)(1).

(13) DUNS + 4 Number

(14) Electronic funds transfer (EFT) banking information

G.3 CDC0_G008 Contracting Officer’s Representative (COR) (Jul 2017)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract.

Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

G.4 CDCP_G009 Contracting Officer (Jul 1999) (a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.5 CDC0_G018 Payment by Electronic Funds Transfer (Feb 2018)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer –System for Award Management, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Office of Financial Resources at 678-475-4510.

I In cases where the contractor has previously provided such information, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: 404-638-5342

Section H - Special Contract Requirements

H.1 Non-Disclosure Agreement for Contractor and Contractor Employees (May 2009)

The contractor shall prepare and submit a Non-Disclosure Agreement (NDA) to the Contracting Officer…