Amendment_1_RFP_NIAID-DAIDS-NIHAI2012150.pdf

Amendment No. 1

NIAID-DAIDS-NIHAI2012150

“Immunology Quality Assessment Program”

Solicitation Number: NIAID-DAIDS-NIHAI2012150

Amendment Number: One (1)

Amendment Issue Date: July 23, 2013

Proposal Due Date/Time: Wednesday, September 12, 2013 at 3:00 PM, Local Time

(Unchanged)

Issued By: John R. Manouelian

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY cornorj@mail.nih.gov Robert Corno, Contract Specialist Phone: 301.451.3691

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 301.451.3694

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 1

mailto:cornorj@mail.nih.gov mailto:manouelj@mail.nih.gov

The purpose of Amendment 1 is to: (1) revise the level of effort requirement; and (2) revise Attachment 4: Technical Proposal Instructions, item G.1.a., to insert the word “manage” in the second to last sentence. As a result of the above revisions, the following areas of the solicitation are revised to read as follows:

SECTION L: INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS,

paragraph 1, General Information, subparagraph d., Level of Effort, is hereby amended to revise the required Full Time Equivalents (FTEs), and shall read as follows:

d. LEVEL OF EFFORT

The Government’s requirement for the work set forth in the Statement of Work of this solicitation is 7.80 Full Time Equivalents (FTE’s) per year. These labor hours include subcontractor labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Full Time Equivalents

Labor Category Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Professional 0.20 0.20 0.20 0.20 0.20 0.20 0.20

Project Manager 1.00 1.00 1.00 1.00 1.00 1.00 1.00

Support 6.60 6.60 6.60 6.60 6.60 6.60 6.60

Total 7.80 7.80 7.80 7.80 7.80 7.80 7.80

NOTE: The labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

OPTIONS FOR INCREASED LEVEL OF EFFORT – Increased Level of Effort for Additional non-U.S. CD4 Labs (7-34):

During the course of the contract, it may be necessary to incorporate additional non-U.S. CD4 Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.40 FTE per Option. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. These labor hours include subcontractor labor hours. It is estimated that the level of effort is constituted as specified below and will be expended approximately as follows:

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 2

Full Time Equivalents Labor Category Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Professional 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Project Manager 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Support 0.40 0.40 0.40 0.40 0.40 0.40 0.40

Total 0.40 0.40 0.40 0.40 0.40 0.40 0.40

NOTE: The labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

OPTIONS FOR INCREASED LEVEL OF EFFORT – Increased Level of Effort for Additional PBMC Labs (35-62):

During the course of the contract, it may be necessary to incorporate additional PBMC Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.85 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. These labor hours include subcontractor labor hours. It is estimated that the level of effort is constituted as specified below and will be expended approximately as follows:

Labor Category Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Professional 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Project Manager 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Support 0.85 0.85 0.85 0.85 0.85 0.85 0.85

Total 0.85 0.85 0.85 0.85 0.85 0.85 0.85

NOTE: The labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 3

ATTACHMENT 3: STATEMENT OF WORK, paragraph 3) Technical Requirements, subparagraph G. Options, subparagraph 2. Options 7 through 62 to Increase Services, subparagraphs a. and b., are hereby amended to revise the required FTEs, and shall read as follows:

2. Options 7 through 62 to Increase Services:

a. Increased Level of Effort for Additional Non-U.S. CD4 Labs (Options 7-34):

During the course of the contract, it may be necessary to incorporate additional non-U.S. CD4 Labs to support new NIAID-supported clinical trials.

Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.40 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised.

b. Increased Level of Effort for Additional PBMC Labs (Options 35-62): During the course of the contract, it may be necessary to incorporate additional cryopreservation Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.85 FTE. The period of performance of an Option for Increased

ATTACHMENT 4: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

SECTION 3 – Technical Plan/Approach, paragraph 1. Technical Plan/Approach, subparagraph G. Project Management and Administrative and Technical Support, subparagraph 1. Overall Project Management and Administration and Technical Support, subparagraph a., is hereby amended to insert the word “manage” into the second to last sentence and shall read as follows:

a. Provide a plan for project organization, staffing, and administration in relation to the planning, initiation, implementation, conduct, monitoring and completion of tasks identified in the Statement of Work. Describe in detail the responsibilities and level of effort for all proposed personnel who will be assigned to the contract, including proposed subcontractors and consultants. Provide an administrative and technical framework indicating clear lines of authority and responsibility for all proposed personnel. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractors. Include a chart of the proposed organizational/administrational structure for the project.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 4

ATTACHMENT 4: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

SECTION 3 – Technical Plan/Approach, paragraph 1. Technical Plan/Approach, subparagraph I. Options, is hereby amended to revise the required FTEs, and shall read as follows:

I. OPTIONS

All offerors MUST address the options below in a clearly marked separate section of their Technical proposal.

Options 7-34 Increased Services: During the course of the contract, it may be necessary to incorporate additional non-U.S. CD4 Labs to support new NIAID supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.40 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. Discuss the approach for adding, through the exercise of Options, the additional non-U.S. CD4 Labs, all to be supported through the end of the contract. Discuss the ability of the Principal Investigator and additional staff to oversee and administer the expansion. Discuss plans to expand the required staff, facilities and other resources necessary to provide the services called for in the Statement of Work to additional Labs.

Options 35-62 Increased Services: During the course of the contract, it may be necessary to incorporate additional PBMC Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.85 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. Discuss the approach for adding, through the exercise of Options, the additional cryopreservation Labs, all to be supported through the end of the contract. Discuss the ability of the Principal Investigator and additional staff to oversee and administer the expansion. Discuss plans to expand the required staff, facilities and other resources necessary to provide the services called for in the Statement of Work to additional domestic and international Labs.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 5

ATTACHMENT 5: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS,

SECTION 3 – Uniform Cost Assumptions (introductory paragraph and FTE tables only) and SECTION 4 - Options, are hereby amended to revise the required FTEs, and shall read as follows:

SECTION 3 – UNIFORM COST ASSUMPTIONS

It is anticipated that a level of effort type contact will be awarded as a result of this solicitation.

The period of performance will be for one year beginning approximately June 30, 2014 through June 29, 2015. The requirement will be the delivery of 7.80 full time equivalents (FTEs) per year for the base period (Year 1) and 7.80 FTEs per year for Options 1-6 (Years 2-7).

FULL TIME EQUIVALENTS

Base Year Option 1 Year 2

Option 2 Year 3

Option 3 Year 4

Option 4 Year 5

Option 5 Year 6

Option 6 Year 7

6/30/14

6/29/15

6/30/15

6/29/16

6/30/16

6/29/17

6/30/17

6/29/18

6/30/18

6/29/19

6/30/19

6/29/20

6/30/20

6/29/21

7.80 7.80 7.80 7.80 7.80 7.80 7.80

FULL TIME EQUIVALENTS

Labor Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Yr 7

Principle Investigator 0.20 0.20 0.20 0.20 0.20 0.20 0.20

Project Manager 1.00 1.00 1.00 1.00 1.00 1.00 1.00

IT Support 0.30 0.30 0.30 0.30 0.30 0.30 0.30

Statistical Support 0.50 0.50 0.50 0.50 0.50 0.50 0.50

Scientist 0.50 0.50 0.50 0.50 0.50 0.50 0.50

Senior Research Technician 1.00 1.00 1.00 1.00 1.00 1.00 1.00

Research Technician 4.00 4.00 4.00 4.00 4.00 4.00 4.00

Administrator 0.30 0.30 0.30 0.30 0.30 0.30 0.30

Total 7.80 7.80 7.80 7.80 7.80 7.80 7.80

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 6

NOTE: The labor mix provided above is the Government's estimate and should not be

SECTION 4 – OPTIONS

Options for Increased Services (Options 7-62):

The Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include the following:

Increased Level of Effort for Additional non-U.S. CD4 Labs (options 7-34): During the course of the contract, it may be necessary to incorporate additional non-U.S. CD4 Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 non-U.S. CD4 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.40 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. Below is a table that shows a breakdown of Options per year and the anticipated level of effort for each.

FULL TIME EQUIVALENTS

Base Year Option 1 Year 2

Option 2 Year 3

Option 3 Year 4

Option 4 Year 5

Option 5 Year 6

Option 6 Year 7

6/30/14

6/29/15

6/30/15

6/29/16

6/30/16

6/29/17

6/30/17

6/29/18

6/30/18

6/29/19

6/30/19

6/29/20

6/30/20

6/29/21

Option 7 Option 8 Option 10 Option 13 Option 17 Option 22 Option 28

0.40 0.40 0.40 0.40 0.40 0.40 0.40

Option 9 Option 11 Option 14 Option 18 Option 23 Option 29

0.40 0.40 0.40 0.40 0.40 0.40

- - Option 12 Option 15 Option 19 Option 24 Option 30

- - 0.40 0.40 0.40 0.40 0.40

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 7

- - Option 16 Option 20 Option 25 Option 31

- - 0.40 0.40 0.40 0.40

- - - - Option 21 Option 26 Option 32

- - - - 0.40 0.40 0.40

- - - - Option 27 Option 33

- - - - 0.40 0.40

- - - - Option 34

- - - - 0.40

Research Technician 0.40 0.40 0.40 0.40 0.40 0.40 0.40

Total 0.40 0.40 0.40 0.40 0.40 0.40 0.40

NOTE: The labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

For costing Options 7-34 for additional non-U.S. CD4 Labs, assume for each Option the enrollment of 10 Labs in the UKNEQAS CD4 proficiency testing program, payment for PT panels and shipment of PT panels 6 times/year by non-courier means to 7 Labs and by courier to 3 Labs; assume paying for the VERIQAS panel once a year to be shipped by non-courier means to 3 Labs and by courier to 2 Labs; assume 1 ten-day visit to a Lab in South Africa for training purposes; and assume hosting one 3-day training session at the IQA.

Increased Level of Effort for Additional PBMC Freezing Labs (options 35-62): During the course of the contract, it may be necessary to incorporate additional PBMC Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option.

Each Option of this type will implement work commensurate with the addition of 10 PBMC freezing Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.85 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. Below

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 8

is a table that shows a breakdown of Options per year and the anticipated level of effort for each.

FULL TIME EQUIVALENTS

Base Year Option 1 Year 2

Option 2 Year 3

Option 3 Year 4

Option 4 Year 5

Option 5 Year 6

Option 6 Year 7

6/30/14

6/29/15

6/30/15

6/29/16

6/30/16

6/29/17

6/30/17

6/29/18

6/30/18

6/29/19

6/30/19

6/29/20

6/30/20

6/29/21

Option 35 Option 36 Option 38 Option 41 Option 45 Option 50 Option 56

0.85 0.85 0.85 0.85 0.85 0.85 0.85

Option 37 Option 39 Option 42 Option 46 Option 51 Option 57

0.85 0.85 0.85 0.85 0.85 0.85

- - Option 40 Option 43 Option 47 Option 52 Option 58

- - 0.85 0.85 0.85 0.85 0.85

- - Option 44 Option 48 Option 53 Option 59

- - 0.85 0.85 0.85 0.85

- - - - Option 49 Option 54 Option 60

- - - - 0.85 0.85 0.85

- - - - Option 55 Option 61

- - - - 0.85 0.85

Option 62

0.85

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150 9

Statistical Support 0.05 0.05 0.05 0.05 0.05 0.05 0.05

Research Technician 0.75 0.75 0.75 0.75 0.75 0.75 0.75

Administrator 0.05 0.05 0.05 0.05 0.05 0.05 0.05

Total 0.85 0.85 0.85 0.85 0.85 0.85 0.85

NOTE: The labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory completion of the work.

For costing Options 35-62 for additional PBMC freezing Labs, assume the cost of receiving, storing, thawing and counting up to 5 samples shipped to the IQA 10 Labs 4 times a year (shipping costs shall be borne by the Labs); assume 1 ten-day visit to a Lab in South Africa for training purposes; and assume hosting one 3-day training session at the IQA.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2012150

STATEMENT OF WORK

IMMUNOLOGY QUALITY ASSESSMENT PROGRAM

RFP-NIAID-DAIDS-NIHAI2012150

1) BACKGROUND and INTRODUCTION:

The mission of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the development of therapies for HIV infection and its complications, and supporting the development of vaccines and other prevention strategies.

Reliable laboratory data are important for the meaningful interpretation of therapeutic and prevention clinical trials/studies and for the appropriate management of subjects enrolled in these studies. Immunological tests, as well as storage of frozen peripheral blood mono-nuclear cells (PBMC) for future testing/study, are included in many NIAID-supported clinical trials. It is, therefore, important to evaluate objectively the ability of laboratories to process PBMC and perform tests reliably, and to enhance laboratory performance by providing assistance and training if deficiencies are identified. The purpose of the Immunology Quality Assessment Program (IQA) is to assess the ability of laboratories located both in the United States (U.S.) and outside (non-U.S.) to accurately and reliably determine CD4 and CD8 T cell lymphocyte counts and percentages and the ability of laboratories to correctly freeze viable PBMC. The IQA provides assistance and training when laboratories have difficulties. The IQA facilitates the adaptation, standardization and quality assessment of new immunological assay methodologies for use in NIAID supported investigations with particular focus on novel, simple tests (point-of-care) for diagnosis and disease monitoring. With the increased research emphasis on T cell activation and inflammation in HIV disease, as well as the study of vaccines in pediatric populations, the IQA shall provide assistance to laboratories to standardize research-use-only tests and design measures to ensure quality and reliability.

The history of this Program is as follows:

1988 – 1993 Initial award to FAST Systems Inc., Gaithersburg, MD 1993 – 1998 Award to FAST Systems Inc., Gaithersburg, MD 1998 – 2007 Award to the University of Medicine and Dentistry New Jersey, Newark, NJ 2007 – 2014 Award to Duke University, Durham, NC Contract No.

HHSN272200700054C.

The IQA shall serve current and future NIAID-sponsored clinical trial networks and collaborating study groups (User Groups). Currently supported User Groups include: the Adult AIDS Clinical Trials Group (ACTG), the International Maternal Pediatric and Adolescent AIDS Clinical Trials Group (IMPAACT), the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN), and the HIV Microbicide Trials Network (MTN), as well as individual grantees conducting research in and outside the U.S.

STATEMENT OF WORK Page 1 of 12 ATTACHMENT 3 March 15, 2013

2) SCOPE:

The Contractor shall provide support to: (1) evaluate the ability of U.S. and non-U.S.

laboratories (Labs) to accurately and reliably perform study-specified immunological tests and viable PBMC freezing; (2) advise and train Lab staff when deficiencies are identified; (3) evaluate immunology-based novel technologies for implementation in multi-site NIAID clinical trials, and (4) host and maintain an electronic data management system and document library in support of contract activities.

3) TECHNICAL REQUIREMENTS:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed, to perform the Statement of Work below. Specifically, the Contractor shall:

A. IMPLEMENT LAB PERFORMANCE STANDARDS AND ASSESS LAB

PERFORMANCE

1. Proficiency Testing (PT) of Immunological Assays

When Labs are chosen by User Groups to participate in a clinical trial, it is critical to evaluate, both initially and on an on-going basis, the ability of Labs to perform protocol-specified tests correctly and reliably. The Contractor determines proficiency by evaluating results obtained with panels of coded (unknown to Labs) Quality Control Materials (QCMs) [Note: Section C provides further information on QCMs]. Panels of QCMs are tested by the Labs at regular intervals. Examples of tests that may be monitored for testing proficiency include flow cytometric evaluations of CD4 and CD8 T cell lymphocyte counts and percentages as well as their subsets (e.g., CD45RO, CD27, CD28, HLADR, CD38) and determination of serum/plasma levels of various cytokines (e.g., TNFα, IFNγ, IL-6) and chemokines (e.g., MIP-1α, MIP-1β).

For each assay specified by the Contracting Officer’s Representative (COR), the Contractor shall perform the following tasks:

a. Provide participating Labs with PT panels of coded QCMs at intervals specified by the COR. Panels shall include QCMs that correspond to the clinical samples used in each assay (e.g., plasma, serum, PBMC).

b. In collaboration with investigators and statisticians identified by the COR, design new or implement currently available tools to capture assay results and information related to the methodology and instrumentation at the Labs.

c. Provide Labs with instructions regarding: i) proper use of QCMs in assays; ii) storage of QCMs at the Lab; and iii) method, format and deadline of PT performance and result reporting. The Contractor shall provide electronic means for retrieval of results whenever the possibility to do so exists.

Retrieve results from the Labs after completion of each round of testing.

STATEMENT OF WORK Page 2 of 12 ATTACHMENT 3

d. Verify the accuracy and completeness of data received from Labs. Discuss the PT results with the COR, and others designated by the COR, in conference calls.

e. Within 10 business days after all PT results are obtained from Labs and the data set is closed, analyze results and determine successful performance based on criteria formulated by the Contractor, relevant Study Groups and the COR. This shall require basic and advanced statistical analyses of data, including parametric and non-parametric approaches.

f. Within 5 business days after completion of the statistical analysis and determination of level of performance, provide each participating Lab with its own Lab-specific performance report. These reports must be provided prior to shipping the next round of proficiency testing.

g. After each round of PT, prepare and submit to the COR and User Groups a

Cumulative Performance Report delineating performance status of all Labs over time.

2. Assessment of Non-U.S. CD4 Flow Cytometry Laboratories

To monitor the performance of Non-U.S. CD4 flow cytometry Labs that support DAIDS-funded clinical studies, it is necessary to obtain proficiency testing panels comprised of stabilized materials that can withstand shipments longer than 24 hours. The United Kingdom National External Quality Assessment Service (UK NEQAS) - www.ukneqasli.org is a provider of such panels. Non-U.S. CD4 laboratories are currently expected to participate in the UK NEQAS CD4 PT program, which periodically ships to Labs panels of coded PT samples and issues each Lab with its own Lab-specific performance report. The UK NEQAS provides the IQA with access to its database to retrieve Labs performance results. Non- U.S. flow cytometry Labs are located mostly in resource limited countries in Africa, Asia, Latin America and the Caribbean. The Contractor shall perform the following:

a. As directed by the COR, directly ship, or coordinate the shipments of, a UK-

NEQAS qualification panel of stabilized whole-blood coded samples to new Labs to assess their initial ability to perform CD4 enumeration. Analyze results received from Labs and determine performance. As directed by the COR, pay for the qualification panels and their shipment to Labs.

b. Facilitate the enrollment of new Labs identified by the COR into the UK NEQAS

CD4 Proficiency Testing Program. This shall require sending an existing method/capability survey to each new lab, receiving the completed survey and communicating with the UK NEQAS to request enrollment. As directed by the COR, pay for the PT panels and their shipment to Labs.

c. Access the UK NEQAS database to review proficiency testing results of each

PT round and/or review Lab-specific performance reports produced by the UK

NEQAS.

d. After each round of PT, prepare and submit to the COR and User Groups a

Cumulative Performance Report delineating the performance status of all Labs over time.

STATEMENT OF WORK Page 3 of 12 ATTACHMENT 3 http://www.ukneqasli.org/

e. Evaluate the adequacy of in-country PT programs for CD4 as possible substitutes for the UKNEQAS program. IQA monitoring of Lab performance in these PT programs shall not result in increased costs to the contract.

3. Proficiency Testing (PT) of Peripheral Blood Mononuclear Cells (PBMC)

Cryopreservation

DAIDS clinical studies often include immunological testing, such as ELISPOT, Intracellular Cytokine (ICC) determinations and T cell subset immunophenotyping, designed to be performed on frozen samples from subjects enrolled in these studies. Because such samples must contain sufficient numbers of viable Peripheral Blood Mononuclear Cells (PBMC), it is important to assess the ability of Labs to adequately process, viably freeze, and ship PBMC. The Contractor shall perform the following:

a. Provide Labs with instructions for processing and viable freezing PBMC at the lab and their shipping to the IQA. Also provide data forms and/or electronic means for capturing viability and yield at the Lab prior to freezing.

b. Receive frozen samples from Labs at intervals specified by the COR.

c. Upon receipt, store frozen samples from Labs in liquid nitrogen for a period of time specified by the COR, thaw and determine viability and yield, analyze results and determine performance success based on criteria formulated by the Contractor and User Groups.

d. Provide each Lab with its own Lab-specific performance report prior to receipt of the next round of PT samples.

e. After each round of PT, prepare and submit to the COR and User Groups a Cumulative Performance Report delineating performance status of all Labs over time.

4. ASSIST, GUIDE AND TRAIN LABS TO IMPROVE LABORATORY

OPERATIONS

Training for commercially available assays is generally provided by the manufacturer. Where training is not provided by a manufacturer, the Contractor shall assist in training Lab personnel. Additionally, when Lab proficiency testing results deviate from accepted values agreed upon by the Contractor, User Group and the COR, the Contractor shall provide assistance to Labs to prevent poor performance from reoccurring. The Contractor shall also provide guidance to Labs when there is concern about results obtained with subjects enrolled in DAIDS-supported clinical studies. The Contractor shall use available methods such as telephone, email, and web conferencing to effectively communicate with the Labs to provide assistance and training. The Contractor shall perform the following:

a. Provide Labs with procedures/Standard Operating Procedures (SOPs) for performing immunologic assays and PBMC processing, as well as instructions for validating instruments, when Labs newly enroll in the IQA programs and whenever procedures are updated by the manufacturers, Contractor, or User

STATEMENT OF WORK Page 4 of 12 ATTACHMENT 3

Groups. As directed by the COR, when new assays are developed, prepare training materials for the new assays (e.g. assay procedures/SOPs, instructional videos, diagrams and pictures), and make training materials available to Labs on the IQA document library. See section 3.D.

b. Send Labs with poor performance an Investigation Report Form to initiate an investigation of the root causes of performance failure and steps for corrective action. The contractor shall use existing Investigation Report Forms or develop such forms for new assays.

c. Review corrective action plans from the Labs and assist with implementation of the plans.

d. Request and review additional materials (e.g. histograms, list-mode data, additional aliquots of frozen PBMC, Standard Operating Procedures, and the Sites’ quality management and corrective action plans) to further investigate the sources and magnitude of difficulties.

e. As needed, after implementation of corrective measures, provide Labs with

QCM panels, or receive frozen samples from Labs, for re-testing; analyze data from the additional panels and report results to Labs, User Groups and COR.

f. Recommend to the COR the planning and conduct of visits to Labs to provide training and guidance based on Lab-specific needs/performance. Upon COR approval to conduct a Lab visit, submit to the COR a written plan providing relevant information including visit purpose/goals, duration, existing materials to be provided and/or new materials requiring preparation, names of visiting contract staff, and budget estimate. Within 10 business days of visit completion, prepare a report delineating observations, activities conducted, resolution of needs/problems and any recommended future plans for additional site-specific guidance/training. Distribute the report to the visited Lab, User Groups and the COR.

g. At the request of the COR, make arrangements for visits to the Contractor by

Lab personnel for the purpose of training.

h. At the request of the COR, provide training at investigator meetings and regional training events.

i. Obtain COR pre-approval of training materials at least 3 business days prior to the date of presentation.

B. EVALUATE IMMUNOLOGY-BASED TECHNOLOGIES FOR IMPLEMENTATION IN

CLINICAL TRIALS

To ensure the continued development and harmonization of immunological assays for HIV and related co-pathogens, especially low-cost simple technologies, and their application in vaccine, prevention and therapeutic studies, the Contractor shall conduct studies to optimize new or existing immunologic methodologies, and investigate and integrate biostatistical methodologies for the evaluation and interpretation of laboratory data.

STATEMENT OF WORK Page 5 of 12 ATTACHMENT 3

1. IMMUNOLOGIC ASSAY METHODOLOGIES

The Contractor shall conduct preliminary studies in-house (at Contractor’s laboratory) and subsequently single- and/or multi-Lab studies with the following aims:

a. Evaluate and/or compare existing or newly developed immunologic assays, assay kits, or reagents to determine performance. Examples of evaluations include methods for the enumeration of CD4-positive T cells, multi-color flow cytometric tests, diagnostics tests (e.g., lateral flow assay for cryptococcal antigen,) responses to vaccine serotypes, and adequacy of various lots of Human AB Serum for functional assays such as lympho-proliferation assays.

b. Evaluate and compare specimen handling, processing, and storage procedures. Examples of evaluations include fresh vs. frozen samples of blood or plasma, length of sample storage, shipping temperature.

c. For each evaluation (in-house, single-Lab or multiple-Labs):

1) draft an evaluation protocol for review by the COR, Study Groups and statisticians, incorporate suggestions and produce a final evaluation protocol;

2) acquire and characterize appropriate QCMs; provide QCMs to selected Lab(s) participating in the evaluation;

3) in collaboration with participating Lab(s) and statisticians, design data collection tools to capture evaluation results and related information about methodology and instrumentation at the Lab(s);

4) provide Lab(s) with instructions regarding proper use of QCMs in assays, storage of QCMs, format and deadlines for reporting test results;

5) receive evaluation results and related information from the Lab(s) and check for accuracy and completeness;

6) within 3 weeks of obtaining evaluation results, assemble and statistically analyze data and forward results to the COR, User Groups and participating Lab(s);

7) within three weeks of the conclusion of each evaluation, prepare a comprehensive Evaluation Report. The report shall include the purpose and design of the evaluation, information on participating Lab(s) and collaborators, complete information on QCM acquisition and characterization, and evaluation results. Distribute reports to the COR, User Groups and participating Labs.

2. ANALYTICAL AND BIOSTATISTICAL METHODOLOGIES

As directed by the COR, collaborate with User Groups and statisticians to evaluate and apply existing or novel statistical models for assessment, interpretation, and validation of immunologic assay test results. The Contractor shall perform the following tasks:

a. Develop quality control parameters for new assays as they are implemented in clinical studies.

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b. Develop approaches for statistical analysis and interpretation of data from immunologic assays. This must include at a minimum, methods for determination of detection limits or cut-off values; methods to evaluate precision, accuracy and linearity of quantitative assays; methods to evaluate and compare intra-and inter-Lab variation, and methods to measure the effect of possible variations of assay parameters on precision, accuracy and linearity.

c. Develop plans for verification of assay performance specifications for implementation in Labs. For unmodified FDA-approved quantitative assays the verification must include analyses of accuracy, precision and linearity. For modified FDA-approved or non-FDA-approved assays, verification must also include analytical sensitivity and analytical specificity.

C. QUALITY CONTROL MATERIALS (QCMs)

The Contractor shall procure materials and reagents necessary for production of QCMs, prepare and characterize the QCMs needed to support work outlined in Sections A and B, above. QCMs will include bio hazardous materials (i.e. blood borne pathogens including HIV, HCV and others).

1. DONOR PROGRAM

The Contractor shall develop and maintain a donor program for obtaining materials from well-characterized (e.g., with known CD4 and CD8 cell counts, HIV and/or HCV RNA levels, CMV reactivity, HLA type) infected and uninfected human subjects. Donor materials must include at a minimum whole blood, serum, plasma and PBMC. Donor materials may include other matrices, such as tissues from lymph nodes and gut epithelium. As directed by the COR, the Contractor shall process large quantities of donor blood (four liters) through leukophoresis.

2. QCMs

Some QCMs for use in the work outlined in sections 3.A and 3.B above shall be produced from clinical samples obtained from the donor program and/or obtained from tissue typing laboratories, blood banks, domestic and international research institutions and reagent/kit manufacturers.

a. As directed by the COR, the Contractor shall obtain the following:

1) whole blood samples from HIV-seropositive donors at various disease stages, seronegative donors, HIV-negative immune-compromised donors, or vaccinated donors;

2) serum/plasma from HIV-negative donors and HIV-positive donors, immune-compromised donors, and/or spiked plasma from seronegative donors containing various concentrations of cytokines (e.g., TNFα, IFNγ), chemokines (MIP-1α, MIP-1β) and soluble markers (e.g., sTNFaRII, sIL- 2R, Neopterin, beta-2 microglobulin);

3) mitogens, pathogen-specific antigens and corresponding controls, labeled monoclonal antibodies, human AB serum, culture media, cell lines, viral isolates, tetramers, peptides and commercial reference standards and reagents;

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4) immunogens such as Cytomegalovirus (CMV), Staphylococcal enterotoxin B (SEB) and Corynebacterium Equi (CEF).

b. Inventory and store, when applicable, aliquots of characterized QCMs under conditions that ensure continued integrity of materials (e.g. activity and viability) and conditions that are appropriate for handling biohazard materials.

As relevant, retain available aliquots from old lots for comparison to new lots.

c. Prior to use in evaluation of Lab performance and in assay/kit evaluation studies, determine QCM characteristics and their optimal use and storage conditions (e.g., hematologic and immunophenotypic profile, concentration of cytokines, titers of neutralizing antibodies, and effect of storage and shipping on QCM stability and activity).

d. Ship QCMs to specified domestic and international destinations under appropriate shipping conditions (e.g. temperature monitoring) and in accordance with IATA/ICAO dangerous goods shipping regulations and other relevant shipping regulations (http://www.iata.org/publications/dgr/Pages/index.aspx).

In addition, the Contractor shall perform the following:

1) execute agreements with receiving institutions regarding relevant standards for safe handling and authorized use of QCM;

2) obtain the appropriate interstate, intrastate and foreign shipping licenses and permits for transporting biohazard materials and arrange overnight (or fastest possible) delivery of shipments to the Labs;

3) Coordinate the shipments of QCMs to the Labs, including prior notice of upcoming shipments.

D. HOST AND MAINTAIN COMPUTERIZED SOFTWARE SYSTEMS

The Contractor shall host and support software for an electronic data management system and document library to track and make available documents in support of activities performed under the contract. The Contractor shall utilize the existing IQA computerized data management system and update the system as necessary The Contractor shall perform the following tasks:

1. Host and Maintain software to store, organize, track, retrieve documents and report on Lab-specific information and activities. The application used shall be web-based and easy to navigate by various characteristics/parameters (e.g., by country, city, name of Lab and document type).

2. Maintain and update Lab-specific documents/information such as Lab contact information, assay systems, reports of IQA assessment visits and proficiency testing performance records.

3. Maintain and update results/publications of IQA-supported evaluation studies.

4. Maintain and update information related to QCMs, such as source/donor, type, amounts, characteristics and lot numbers, storage information, shipping dates to Labs and testing dates.

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5. Create and make publicly available a document library that includes Contractor presentations, and guidance and training materials/resources organized by topics that are easily searchable.

6. Post summary information such as list(s) of supported Labs that indicate name of lab, overseeing Contractor staff and User Group affiliations.

7. Post documents such as forms, templates, and shells.

8. Provide tracking information for stored documents that includes name/type of document, description, author/origin, date received and date stored by the Contractor.

9. Provide for report capabilities to allow the compilation of Lab information that include Lab name, location, testing capabilities, and participation in PT programs.

a. Maintain the computerized system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA). This shall include a comprehensive assessment of the management, operational, and technical security controls in the system to determine the extent to which the controls are implemented correctly, operating as intended, and producing the desired outcome with respect to meeting a specified set of security requirements for the system. These actions are referred to as System Assessment and Authorization (SA&A). The NIAID Information System Security Officer (ISSO) performs the Assessment to support the NIAID CIO decision to authorize operation of an information system and to explicitly accept the risk to NIAID data based on the implementation of an agreed-upon set of security controls.

10. Provide software-specific security measures for Lab-specific proficiency testing data accessible only to Lab staff and to individuals identified by the

COR.

E. ADMINISTRATIVE AND TECHNICAL SUPPORT

The Contractor shall be responsible for the following:

1. Meetings and Teleconferences

The Contractor shall be responsible for the following:

a. Contract Initiation Meeting

Within 30 business days after the effective date of the contract, participate in a one-day Contract Initiation Meeting with the COR, the Contracting Officer and other NIAID personnel designated by the COR, to be held at the Contractor’s site. The purpose of the Contract Initiation Meeting shall be to orient the Contractor to NIAID contract procedures.

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b. Annual Site Visits with the Contractor

Arrange Annual Site Visits at contractor’s site for NIAID contract and program staff, designated by the COR, to review and discuss the following: project progress and costs; problems, obstacles and approaches to overcoming them;

recommendations for modifications in project timelines, objectives, and research approaches/methodologies based on outcomes to date; and future plans. These site visits shall be attended by the Principal Investigator, the Project Manager, other Contractor staff and, as needed, the Contractor’s business representative.

c. Teleconferences

1) Plan and conduct periodic teleconferences with key Contractor staff, the COR, and other DAIDS staff designated by the COR to review overall progress. Provide the COR with teleconference agendas and relevant materials.

2) As needed, plan and conduct teleconferences with key Contractor personnel and specific Lab investigators (identified by meeting content and agenda topic) to review Lab-specific problems, resolutions and progress towards achieving reliable performance.

2. Dissemination of Immunologic Quality Assessment Technical and Scientific Data

The Contractor shall disseminate technical and scientific data from activities conducted under this contract through publication and presentation of data and through conference calls and meetings with relevant parties. The Contractor shall perform the following tasks:

a. Prepare, within 3 months of final data analysis of evaluation studies, materials to support preparation of scientific manuscripts for publication in peer reviewed journals, and submit these materials to the COR.

b. Present data at NIAID-sponsored meetings, and at domestic and international scientific meetings as approved by the COR. Materials submitted for presentation and final presentations must be submitted to the COR at least 3 business days prior to the date of submission or presentation.

F. EXECUTE INITIAL AND FINAL TRANISTION

1. Initial Transition

In the event of transition to a new contractor, the Contractor shall ensure an orderly, secure, and efficient transition of contract activities and contract-related data, documents, and other materials from the previous contractor, as follows:

a. Within 3 business days of the effective date of the contract, the COR will provide the Contractor with a copy of the incumbent contractor’s Final Transition Plan specifying transition requirements and processes. The Initial Transition shall require the transfer of contract-related materials and data from the incumbent Contractor that include the following:

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1) stored QCMs/Reagents/biological samples/tissues

2) proficiency testing records of Labs, assay development/evaluation data files, QCM inventory files, and statistical analysis data files

3) communication and correspondence files,

4) labeled and inventoried paper files, QA data, reports, and laboratory procedures/SOPs

5) copies of all computerized data files and software systems (with source code, documentation and specifications)

b. Within 10 business days of the effective date of the contract, the Contractor shall submit to the COR and Contracting Officer for approval, an Initial Transition Plan and timeline for the transition of activities and contract-related materials from the incumbent contractor, and the activities required for having the Contractor’s facility ready for providing support to Labs. The Plan shall include coordination with the Labs to ensure an orderly transition.

c. Upon COR and Contracting Officer approval of the Initial Transition Plan, implement and complete the transition within 30 business days following the effective date of the contract.

2. Final Transition

Provide a Final Transition Plan for the orderly, secure and efficient transition of contract-related materials, data, and activities to a successor contractor or the Government, if a Contractor other than the incumbent is awarded a follow-up contract for this requirement. This plan shall be subject to written approval by the COR and Contracting Officer.

a. The Draft Final Transition Plan shall be submitted to the COTR and

Contracting Officer not later than 6 months prior to the completion date of the contract for review and comment. Upon receipt of comments, the Contractor shall revise the Draft Final Transition Plan as necessary.

b. The Final Transition Plan shall be submitted for written approval to the COR and Contracting Officer not later than 2 months prior to the completion date of the contract. The Contractor shall implement and complete the Transition Plan by the completion date of the contract. The Contractor shall maintain full operational capacity during the final transition period.

c. The transition process shall require the transfer of contract-related material to include:

1) stored QCMs/Reagents/biological samples/tissues

2) proficiency testing records of Labs, assay development/evaluation data files, QCM inventory files, and statistical analysis data files

3) communication and correspondence files,

4) labeled and inventoried paper files, QA data, reports, and laboratory procedures/SOPs

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5) copies of all computerized data files and software systems (with source code, documentation and specifications)

[END OF STATEMENT OF WORK FOR BASE PERIOD]

G. OPTIONS

In addition to the above functions and services to be provided for the Base period, the Government may exercise, at its discretion, Options for additional level of effort as follows: 1) Options to extend the term of the contract; and 2) Options to accommodate significant increases in work. These Options are defined as follows:

1. Options 1 through 6 to Extend the Term of the Contract: The Government may exercise options to extend the period of the contract beyond the base period (Year 1), annually, for a total contract period of up to 7 years. Assume that the scope and types of activities as outlined herein (i.e., for Year 1 of the contract) would be continued for each succeeding annual contract period up to 7 total years.

2. Options 7 through 62 to Increase Services: The Government may exercise

Options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include the following:

a. Increased Level of Effort for Additional Non-U.S. CD4 Labs (Options 7-34):

During the course of the contract, it may be necessary to incorporate additional non-U.S. CD4 Labs to support new NIAID-supported clinical trials.

Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.40 FTE. The period of performance of an Option for Increased

b. Increased Level of Effort for Additional PBMC Labs (Options 35-62): During the course of the contract, it may be necessary to incorporate additional cryopreservation Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 0.85 FTE. The period of performance of an Option for Increased

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ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS

It is strongly…