RFP_2015-N-17138_Final_05-22-15.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 61

2. CONTRACT NO.

3. SOLICITATION NO.

2015-N-17138

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

05/22/2015

6. REQUISITION/PURCHASE

NO.

00HCVJED-2015-80778

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road

Atlanta, GA 30341-5539

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 5 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 2920 Brandywine Road, Colgate Bldg, Security Desk until 1:00p local time 06/22/2015

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

Kim Morris

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2621

C. E-MAIL ADDRESS

kmorris1@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 36

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

X C DESCRIPTION/SPECS./WORK STATEMENT 4 X J LIST OF ATTACHMENTS 39

X D PACKAGING AND MARKING 11 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 12 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 13 X K OTHER STATEMENTS OF OFFERORS 40

X G CONTRACT ADMINISTRATION DATA 16 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 41

X H SPECIAL CONTRACT REQUIREMENTS 23 X M EVALUATION FACTORS FOR AWARD 57

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 FACILITY 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 2536 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention

Acquisition and Assistance Branch 1

2920 Brandywine Road, MS E-15

Atlanta, GA 30341-5539

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

ITEM

SUPPLIES / SERVICES

QTY / UNIT

UNIT PRICE

EXTENDED PRICE

BASE YEAR

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

1 Job

September 2015 through September 2016

OPTION YEAR 1

September 2016 through September 2017

OPTION YEAR 2

September 2017 through September 2018

OPTION YEAR 3

September 2018 through September 2019

OPTION YEAR 4

September 2019 through September 2020

B.1. Brief Description of Supplies or Services

The Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), requires the services of a Contractor to provide tuberculosis (TB) laboratory services to the U.S.-affiliated Pacific Islands (USAPI).

B.2. Contract Type

This is a cost plus fixed fee (CPFF) type contract with option years. This contract shall contain a Base Year and four

(4) Option Years. The exercise of an option shall be in accordance with FAR 52.217-9, Option to Extend the Term of the Contract (March 2000).

B.3. Estimated Cost – Option

a. The estimated cost of the BASE PERIOD of this contract is $ .

b. The fixed fee for the BASE PERIOD of this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Section I of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the BASE PERIOD is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION in Section H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost Fixed Fee Estimated Cost Plus Fixed Fee

Base Year

Option Year 1

Option Year 2

Option Year 3

Option Year 4

Total [Base Period and Options]

B.4. Performance-Based Preference

Pursuant to FAR 37.102(a) (2), the Contracting Officer will use performance-based acquisition methods to the maximum extent practicable.

Title of Project: Tuberculosis Laboratory Testing for the U.S.-affiliated Pacific Islands

SECTION C - PERFORMANCE WORK STATEMENT

C.1 – BACKGROUND

The U.S. prevention and control agenda for the Centers for Disease Control and Prevention (CDC) Division of Tuberculosis (TB) Elimination includes the 50 states, Puerto Rico, U.S. Virgin Islands, and six U.S.-affiliated Pacific Island (USAPI) jurisdictions. The USAPI include the U.S. Territories of 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 United States. 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.

As indicated in the Essential Components of a Tuberculosis Prevention and Control Program1, one of the core components for effective TB control programs involves 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 lack the capacity and expertise to fulfill this essential program activity. The following tasks are needed to ensure the delivery of TB laboratory services in the USAPI:

1. Establish and implement a logistical plan and protocol to ship TB specimens

2. Identification of Mycobacterium tuberculosis and drug resistance

3. Quality assurance

4. On-site technical assistance site visits

5. Training of USAPI TB laboratory staff

6. Expert laboratory consultation

C.2 – PROJECT OBJECTIVE

The project objective is to provide TB laboratory services for the USAPI. TB laboratory services are not readily available in the USAPI, creating a barrier for the CDC to ensure effective TB control and prevention in the region.

Quality and timely TB laboratory services will ensure that CDC is able to provide medical consultation and technical assistance to the TB programs. The local public health infrastructure and resources in the USAPI cannot support the TB laboratory needs promulgated by CDC without access to a contract laboratory.

C.3 – SCOPE OF WORK

All work will be performed at the contractor’s facility and the contractor shall, as an independent organization and not as an agent of the United States Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities to perform the services required in the contract.

The Contractor shall perform the tasks outlined in SECTION 4 for the local TB laboratories and TB control programs located in the following ten USAPI sites: (1) Pago Pago in American Samoa; (2) Saipan in CNMI; (3) Mangilao in Guam; (4) Chuuk, (5) Kosrae, (6) Pohnpei, and (7) Yap in the FSM; (8) Ebeye and (9) Majuro in the RMI; and (10) Koror in the Republic of Palau.

The period of performance will include a base year plus four (4) option years. The total performance period will be for a total of five (5) years (60 months) if all options are exercised. The Contractor shall process up to 5,000 specimens each contract year.

1 http://www.cdc.gov/mmwr/pdf/rr/rr4411.pdf http://www.cdc.gov/mmwr/pdf/rr/rr4411.pdf

C.4 – TASKS TO BE PERFORMED

Task 1.0 – Communication Communicate with the ten USAPI TB laboratories and programmatic staff via telephone, fax, and e-mail, to allow notification of critical values, and notification of the availability of results. Implement security measures to maintain confidentiality and privacy of identifiable health information in all communication. Participate in regular (e.g., quarterly) conference calls with laboratory managers and technicians from the ten USAPI TB laboratories to present and discuss relevant information and resolve issues that might be experienced by the local laboratories.

Participate in regular (e.g., monthly) conference calls with CDC and regional TB laboratory experts to discuss successes, challenges, and potential solutions. Include as part of these monthly meetings, discussion of data assessments of workload trends, and results for AFB smear and Xpert MTB/RIF received from local USAPI laboratories with specimen submissions.

Task 2.0 – Transportation of Specimens Establish and implement an airline and courier-based transportation logistical plan and protocol to ship and receive TB specimens from the ten (10) USAPI TB laboratories on a schedule that allows for timely processing.

Subtask 2.1 – Packaging Supplies Provide all packaging supplies which include, but not limited to, leak-proof specimen bags, absorbent material, Styrofoam containers, UN approved boxes, packaging tape, mailing labels, and shippers declaration forms. Fulfill requests for supplies within five business days of receipt. Provide written procedures for requesting supplies and packaging specimens for shipment.

Subtask 2.2 – Shipping of Specimens Provide written procedures for shipping specimens from each of the ten (10) 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 site and the CDC Contracting Officer Representative (COR) within 48 hours and shall provide an updated written procedure within five (5) business days.

Task 3.0 – 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 ten (10) sites within the U.S-affiliated Pacific Islands. Ensure that testing algorithms for the region, as established by CDC, are followed.

Subtask 3.1 –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 the references in SECTION 8. 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 3.2 – Direct Detection Perform nucleic acid amplification testing or other rapid tests for direct detection of M. tuberculosis using validated and established procedures described in the references in SECTION 8. Sample will be referred to

CDC for Molecular Detection of Drug Resistance when resistance to rifampin is detected by the Contractor and/or at the USAPI TB laboratory or when requested by healthcare provider due to clinical situation (e.g., inability to tolerate first-line drug or lack of clinical response).

Subtask 3.3 – Drug-Susceptibility Testing Perform growth-based drug susceptibility testing on isolates of M. tuberculosis to identify susceptibility to first line anti-TB drugs to include isoniazid, rifampin, pyrazinamide, and ethambutol, using validated and established procedures described in the references in SECTION 8. For susceptibility testing of second line anti-TB drugs, refer the isolate to CDC or a reference laboratory. Provide the name of the reference laboratory selected to provide second line drug susceptibility testing and a brief description of their testing methods and timelines. At minimum, the second-line panel should include a fluoroquinolone and all three (3) second-line injectable drugs (i.e., amakacin, capreomycin, and kanamycin).

Subtask 3.4 – 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 4.0 – Reporting and Storage of Results and Specimens The following subtasks shall be completed by the Contractor:

Subtask 4.1 – Reporting of Critical Value Test Results Report critical value test results via telephone, fax, or 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 4.2 – Reporting and Storage of Results Maintain a secured web-based electronic information system to store and transmit test results to the submitter. Results shall be available within 24 hours after results are known. The Contractor shall store the test results for at least the duration of this contract. Provide the following parties access to the Contractor’s secured web-based electronic information system to retrieve test results and provide written instructions on how to operate the system:

Each of the ten (10) USAPI TB laboratories and TB control program staff, and

CDC COR designees

Subtask 4.3 – Storage of Specimens Archive isolates in appropriate refrigerated storage areas for the duration of this contract. Safely and legally destroy isolates at the expiration of this contract.

Subtask 4.4 – Reporting of Work Load Submit a monthly work load report that details the total number of clinical specimens that were received and processed for each of the ten USAPI TB laboratories and a compilation of local results for smear and GeneXpert.

Task 5.0 – Quality Assurance The following subtasks shall be completed by the Contractor:

Subtask 5.1 – Development of a Quality Assurance Plan Develop and/or update a TB laboratory quality assurance plan using published criteria described in the references in SECTION 8 to ensure consistency and measure improvement in delivering accurate local AFB-smear microscopy results. Include protocols for using proficiency testing panels, blinded slide rechecking, and GeneXpert as part of an external quality assessment.

Subtask 5.2 – Implementation and Monitoring Disseminate the quality assessment plan and external quality assessment protocol to the ten (10) USAPI TB laboratories and the CDC COR. Implement the quality assessment plan within 60 calendar days after contract award and conduct external quality assessment every contract year. All materials needed for the ten (10) USAPI TB laboratories to complete the external quality assessment shall be provided by the Contractor.

Subtask 5.3 – Reporting Outcomes Develop a report within ten (10) business days of completion of the external quality assessment that summarizes the results of all activities that are part of the quality assurance plan and submit this report to the CDC COR.

Task 6.0 – On-site Technical Assistance Site Visits Conduct on-site technical assistance site visits to each of the ten (10) USAPI laboratories for a minimum of one (1) business day every contract year to assess local lab equipment and staff capabilities. An assessment tool comparable to the one published in the references in SECTION 8 shall be used. Coordinate with each USAPI laboratory directly to schedule site visits and provide the CDC COR with a site visit calendar every contract year.

Following the site visit, a written report summarizing observations and recommendations shall be submitted to the

CDC COR.

Task 7.0 – Training of USAPI TB Laboratory Staff Develop, maintain, and deliver an annual TB laboratory training. Training materials shall provide the ability for local TB laboratory staff to train others in his or her jurisdiction. Trainings shall occur either during on-site technical assistance site visits (Subtask 6.0) and/or at a centralized regional location in the USAPI. Trainings shall be based on knowledge gaps identified during site visits and shall include, at a minimum, 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

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 external quality assessments

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

Maintain a training record noting the training participant’s name and jurisdiction, training date, content, and test scores (pre and post). Training records shall be provided to the CDC COR.

Task 8.0 – Expert Laboratory Consultation The Contractor shall be available for consultation by phone and email to the ten (10) USAPI TB laboratory and TB control program staff for technical assistance and interpretation of results.

C.5 - QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

(a) For this Performance Based contract, NCHHSTP must effectively validate in a timely manner the performance of the Contractor in meeting the services required. This QASP provides a systematic surveillance method for the services and describes the methodology by which the Contractor’s performance will be monitored.

(b) Each task under Section C.4. will be surveilled in accordance with the QASP in Section J, List of Attachments.

Additional surveillance may be added as needed by CDC/NCHHSTP.

(c) Please note that if the work products for a profile are not accepted by CDC/NCHHSTP, they shall be considered as having been of unacceptable quality. Furthermore, any rejected deliverables will be considered as having missed their due date, and will be so noted in the contractor’s performance assessment report (CPARS).

C.6 - PERFORMANCE REQUIREMENTS

The following Performance Based Matrix specifies the performance standards and acceptable quality levels (AQL) for this contract.

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 contract year.

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 90 days of the end of the service period.

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

No invoices are submitted beyond 90 days of the end of the service period.

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 contract year.

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 CO, 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

Performance Objective and Description Performance Standard Acceptable Quality

Level Surveillance

Method Incentive and Disincentive

Completion of Deliverables Deliverables are completed within the timeframes specified.

95% 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

Submission of Reports Reports of high quality, fully edited, and accurate are submitted within 30 days of the end of the service period or activity (e.g., work load reports, external quality assessment outcomes, site visits, and training records).

95% 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

C.7 - MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

In addition to the published standards noted as references in SECTION 8, the contractor must ensure compliance with the following items:

1. The offeror must be a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory and provide evidence of current CLIA certification (www.cms.hhs.gov/clia/).

2. The offeror must be International Air Transportation Association (IATA) trained and certified and provide evidence of successful completion of IATA approved training for the transportation of dangerous goods (infectious substances and diagnostic specimens) and produce proper shipping, importation, exportation permits for infectious and diagnostic specimens.

3. The offeror must describe their ongoing participation in External Quality Review (EQA) and document EQA as part of the offeror’s standard operating procedures.

4. The offeror must describe their biosafety infrastructure (http://www.cdc.gov/biosafety/), practices, safety equipment, facilities, and training in handling infectious agents and associated procedures.

5. The offeror must describe their experience in performing full panel of microbiological testing with M.

tuberculosis.

6. The offeror must describe their ability to safely handle M. tuberculosis cultures.

7. The offeror must describe their infection control program and describe the surveillance program used to monitor the possibility of lab acquired infection.

8. The offeror must describe how they meet the qualifications required for performing the work in this contract which includes providing a record of the number of M. tuberculosis laboratory tests and method of performing AFB smears, culture, species identification, and anti-microbial drug susceptibility tests for the last 5 years.

9. The offeror must describe TB specific equipment used for performing the TB tests.

10. The offeror must describe information systems on hand and how they are used to relay test results to the medical community.

11. The offeror must ensure adequate number of staff TB bench microbiologists and supervisory microbiologists

(or contract with such staff) in order to perform all aspects of this contract.

12. The offeror must describe how they will implement HIPPA reporting standards.

http://www.cdc.gov/biosafety/

C.8 - REFERENCE MATERIALS

These references describe the standards required from the contractor’s proposal for TB laboratory testing:

1. 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; 2002. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm

2. 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

3. Clinical and Laboratory Standards Institute (CLSI). Laboratory Detection and Identification of Mycobacteria;

Approved Guideline. CLSI document M48-A. 2008, Wayne, Pennsylvania.

4. Clinical and Laboratory Standards Institute (CLSI). Susceptibility Testing of Mycobacteria, Norcardiae, and Other Aerobic Actinomycetes, Approved Standard–Second Edition. CLSI document M24-A2. 2011, Wayne, Pennsylvania.

5. 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.

6. Tenover FC, Crawford JT, Huebner RE, Geiter LJ, Horsburgh CR Jr, Good RC. The resurgence of tuberculosis: is your laboratory ready? J Clin Microbiol 1993;31:767–70.

7. 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 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5406a1.htm http://www.who.int/ihr/training/laboratory_quality/11_cd_rom_tb_eqa_wpro.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. The Contracting Officer or the duly authorized representative (who for the purposes of this contract shall be the Contracting Officer’s Representative) will perform inspection and acceptance of materials and services to be provided under the contract. The contract will identify who will perform inspections and where the inspections will be performed.

E.2. This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR SOURCE TITLE AND DATE

52.246-1 Contractor Inspection Requirements (April 1984) 52.246-5 Inspection of Services – Cost-Reimbursement (April 1984)

SECTION F – DELIVERIES OR PERFORMANCE

F.1. Period of Performance

a. The period of performance shall be sixty (60) months from the effective date of contract award.

b. The period of performance for the BASE YEAR shall be from September 2015 through September 2016.

c. If the Government exercises its option(s) pursuant to the OPTION PROVISION in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

Option Year 1

September 2016 through September 2017

Option Year 2

September 2017 through September 2018

Option Year 3

September 2018 through September 2019

Option Year 4

September 2019 through September 2020

F.2. Place(s) of Performance

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

F.3. Deliveries

The items specified below as described in Section C of this contract, will be required to be delivered F.o.b.

Destination as set forth in FAR 52.247-34, F.o.b. Destination (November 1991), and in accordance with and by the date(s) specified below.

F.3.1. The following deliverables are required for this contract.

Item

No.

Task Description Due Date Method Frequency Recipient

1 1.0 Participate in regular (e.g., quarterly) conference calls with laboratory managers and technicians from the ten USAPI TB laboratories to present and discuss relevant information and resolve issues that might be experienced by the local laboratories.

Initial conference call within 90 days after contract award and quarterly there afterwards

Phone No Less Than Quarterly

(Base & Option Years) n/a

2 1.0 Participate in regular (e.g., monthly) conference calls with CDC and regional TB laboratory experts to discuss successes, challenges, and potential solutions. Include as part of these monthly meetings, discussion of data assessments of workload trends, and results for AFB smear and Xpert MTB/RIF received from local USAPI laboratories with specimen submissions.

Initial conference call within 30 days after contract award and monthly there afterwards

Phone No Less Than Monthly

(Base & Option Years) n/a

3 2.0 Written airline and courier-based transportation logistical plan and protocol to ship and receive TB specimens from the ten USAPI TB laboratories on a schedule that allows for timely processing.

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

4 2.1 Written procedures for requesting supplies and packaging specimens for shipment. Document shall include appropriate illustrations for various packaging steps.

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

5 2.2 Written procedures for shipping specimens from each of the ten USAPI TB laboratories to the Contractor.

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

6 2.2 Written notification of changes to shipping regulations, guidelines, and/or procedures.

48 hours from change

Email As Needed

(Base & Option Years)

CO

Item

No.

Task Description Due Date Method Frequency Recipient

7 2.2 Written procedures for any updates made to shipping procedures.

5 business days from written notification of change in shipping regulations, guidelines, and/or procedures

Email As Needed

(Base & Option Years)

CO

and

COR

8 3.0 Written description of the methods used in the laboratory, including those for specimen processing, direct detection, acid-fast bacilli (AFB) smear, culture, identification, and drug susceptibility testing (DST), as well as a brief overview of testing algorithm. Also provide turnaround time parameters for specimen collection to specimen shipment, turnaround time parameters for specimen shipment to Contractor receipt of specimen, and turnaround time parameters for Contractor receipt of specimen to issue of results.

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

9 3.0 Organizational chart of personnel performing laboratory testing for TB and include a designated laboratory contact with contact information.

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

10 3.3 If applicable, name of the reference laboratory selected to provide 2nd line drug susceptibility testing and a brief description of their testing methods and timelines.

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

11 4.1 Written description of the method that will be used to report critical value test results via telephone, fax, or e-mail within 24 hours after results are known.

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

12 4.2 Provide the following parties access to the Contractor’s secured web-based electronic information system to retrieve test results and provide written instructions on how to operate the system:

Each of the ten USAPI TB laboratories and TB control program staff, CDC Project Officer designees

10 business days after contract award

Email Once

(Base Year Only)

CO

and

COR

13 4.4 Submit a monthly work load report that details the total number of clinical specimens that were received and processed for each of the ten USAPI TB laboratories and a compilation of local results for smear and GeneXpert.

30 calendar days after the end of the service period

Email Monthly

(Base & Option Years)

CO

14 5.1 Written TB laboratory quality assurance plan to ensure consistency and measure improvement in delivering accurate local AFB-smear microscopy results. The plan shall include protocols for using proficiency testing panels, blinded slide rechecking, and GeneXpert as part of an external quality assessment.

30 calendar days after contract award

Email Once

(Base Year Only)

CO

and

COR

15 5.2 Disseminate the quality assessment plan and external quality assessment protocol.

45 calendar days after contract award

Email Once

(Base Year Only)

CO

and

COR

16 5.2 Implement quality assessment plan. 60 calendar days after contract award n/a Once

(Base Year Only) n/a

17 5.2 Conduct external quality assessments. 90 calendar days after contract award n/a Annually

(Base & Option Years) n/a

18 5.3 Written report of the external quality assessment that summarizes the results of all activities that are part of the quality assurance plan.

10 business days after completion of the external quality assessment

Email Annually

(Base & Option Years)

CO

and

COR

19 6.0 Calendar containing dates of site visits. 60 calendar days after contract award

Email Annually

(Base & Option Years)

CO

and

COR

20 6.0 Site visit report containing:

Dates and time of visit

Name and position title for persons met

Visit objectives, outcomes, recommendations

Action items and timelines for completion

Method for measuring completion of action items

30 business days after completion of site visit

Email Annually

(Base & Option Years)

CO

and

COR

21 7.0 Training record containing:

Training participant’s name and jurisdiction

Training date

Content

Test scores (pre and post)

30 business days after completion of training

Email Annually

(Base & Option Years)

CO

F.4. Clauses Incorporated By Reference, FAR 52.252-2 (February 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://acquisition.gov/far/.

FAR SOURCE TITLE AND DATE

52.242-15 Stop Work Order (August 1989) https://acquisition.gov/far/

SECTION G – CONTRACT ADMINISTRATION DATA

G.1. Contracting Officer

(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.2. Contracting Officer’s Representative (COR)

Performance of the work hereunder shall be subject to the technical directions of the designated Contracting Officer’s Representative (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 feels that 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 in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was not within the scope. 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. 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 delegation memorandum for the COR. Any changes in COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor. The Government may unilaterally change its COR designation.

The COR for this contract who is responsible for day-to-day oversight of the Contractor’s performance is:

Name: TBD Address:

Telephone:

Email:

G.3. Key Personnel, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The following individual(s) are considered to be essential to the work being performed hereunder:

[To be specified prior to award]

NAME TITLE

G.4. Payment by Electronic Funds Transfer (Dec 2005)

(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 – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting 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 Financial Management Office at (404) 498-4050.

(c) In cases where the contractor has previously provided such designation, 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 Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: 404-638-5342

G.5. CDC42.0001: Contractor Performance Assessment Reporting System (CPARS) Requirements (April 2013)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

Provide the current CPARS representative information below in your business proposal.

PRINT OR TYPE NAME

EMAIL ADDRESS AND PHONE NUMBER

G.6. CDC42.0003: Billing Rates (May 2013)

(a) As defined in FAR Subpart 42.7, Billing Rate means an indirect cost rate established temporarily for interim reimbursement of incurred indirect costs. Billing rates may be adjusted as necessary pending establishment of final indirect rates.

(b) Notwithstanding the provisions of the clause entitled Allowable Cost and Payment (FAR 52.216-7), allowable indirect costs under this contract shall be determined by applying the following provisional billing rates to the bases specified below:

TYPE EFFECTIVE RATE LOCATION APPLICABLE TO BASE

PERIOD

(FROM – TO)

Bases: (1)

(c) The above rates are provisional billing rates only and shall apply from the date of award until such time as the rates are revised by modification. Any modification to change the above rates will also state the effective period covered by the revised rates.

(d) Billing rates may be prospectively or retroactively revised by mutual agreement of the Contracting Officer and the Contractor at either party’s request. When agreement cannot be reached, the billing rates may be unilaterally determined by the Contracting Officer as set forth in FAR 42.704.

(e) Final indirect rates shall be established in accordance with FAR Clause 52.216-7, Allowable Cost and Payment.

As required by that clause, the Contractor shall submit an adequate final indirect cost rate proposal to the Contracting Officer and auditor within the six (6) month period following the expiration of each of its fiscal years.

Upon receipt of the final indirect cost rate proposal and pending the establishment of final indirect cost rates, the http://www.cpars.gov/

Contractor and the Government may mutually agree to revise the provisional billing rates to reflect the proposed indirect cost rates until the proposal has been audited and settled.

G.7. Billing Instructions for Negotiated Cost-Type Contracts (Mar 2006)

Introduction Reimbursement procedures related to negotiated cost-type contracts require that Contractors submit to the Government adequately prepared claims. The instructions that follow are provided for Contractors’ use in the preparation and submission of invoices or vouchers requesting reimbursement for work performed. The preparation of invoices or vouchers as outlined below will aid in the review and approval of claims and enable prompt payment to the Contractor.

1. Forms to Be Used

In requesting reimbursement, Contractors may use the regular Government voucher form, Standard Form 1034, “Public Voucher for Purchases and Services Other Than Personal,” and Standard Form 1035, “Continuation Sheet,” (See Section J, List of Attachments) or the Contractor’s own invoice form. If the Contractor uses his own invoice, the billing must conform to the instructions set forth herein.

2. Preparation of Invoices or Vouchers

A.) Summary of All Costs On the attached Standard Form 1034, identified as Attachment J-3, a summary of all current costs must be shown.

This summary consists of a list identifying the general categories and the amounts incurred during the period covered by the billing, together with the portion of fixed fee (if any) payable for that period. The reimbursable costs incurred and the dates of the period for which the charges are claimed must fall within the period specified in the contract.

B.) Details of Costs Claimed On the attached Standard Form 1035, identified as Attachment J-4, a detailed breakdown must be provided to substantiate the categories shown on the summary of costs. The following describes some of the categories that might appear on your billings:

(1) Direct Labor Direct Labor costs consist of salaries and wages paid for scientific, technical, and other work performed directly for the contract and pursuant to the contract terms. Labor costs, excluding fringe benefits and overtime premium pay, will be billed as follows:

List the titles and amounts for employees whose salaries or wages, or portions thereof, were charged to the contract; show the rate (or hours) worked, and amount for each individual. The cost of direct labor, which is charged directly to the contract, must be supported by time records maintained in the contractor’s office.

(2) Fringe Benefits If it is the Contractor’s established practice to treat fringe benefits as a direct cost, such costs should be billed separately as a single item.

NOTE: Fringe benefits, bonuses, etc., are usually treated as indirect costs for inclusion in the overhead pool;

however, they may be treated as direct labor costs or as an “Other Direct Charge” if such treatment is in accordance with the Contractor’s established accounting procedures.

(3) Premium Pay

Premium pay is the difference between the rates and amounts paid for overtime or shift work and amount normally paid on a straight time basis. Generally such pay is not included in the direct labor base and should not be included in the billing for “direct labor” unless the Contractor has consistently followed this practice in the past as a matter of policy. Premium pay of any kind unless provided for in the contract must be authorized by the Contracting Officer in advance. Billings for unauthorized premium pays have caused frequent delays in payment due to suspensions and exchange of correspondence. Citations of authorization for premium pay will avoid delays in payment. Authorized premium pay may be shown as a single item on the summary of costs.