Amendment_1 _RFP_NIAID-DAIDS-NIHAI2015045.pdf

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 1

Amendment No. 1

NIAID-DAIDS-NIHAI2015045

“NIAID Clinical Site Monitoring”

Solicitation Number: NIAID-DAIDS-NIHAI2015045

Amendment Number: One (1)

Amendment Issue Date: February 26, 2016

Proposal Due Date/Time: Tuesday, March 15, 2016 at 3:00 PM, Local Time (Unchanged)

Issued By: John R. Manouelian

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY patrick.finn@nih.gov Patrick Finn, Contract Specialist Phone: 240.669.5401

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 240.669.5152

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 the amendment number and the date of the amendment on each copy of the submitted proposal. 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.

The purpose of this Amendment is to: (1) provide responses to questions from potential offerors, regarding the solicitation; (2) revise Article B.2. Estimated Cost – Option; (3) revise Article C.1. Statement of Work; (4) revise Section L – Instructions, Conditions, and Notices to Offerors; (5) revise Attachment 3, Statement of Work; (6) revise Attachment 4, Additional Technical Proposal Instructions; and (7) revise Attachment 5, Additional Business Proposal Instructions.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 2

The solicitation is amended to provide the following responses to questions received from potential offerors:

Question 1 Attachment 4, p. 3, 3.2, Are the entire SOPs required in the technical proposal or would an outline of the SOP meet the requirement to provide specific examples? If the entire SOPs are required, are they included in page limitation?

Response to Question 1 The Government’s intent is to get specific examples of SOPs proposed for the 6 bulleted SOP topics listed on page 3 of Attachment 4, since we feel that these are important topics and we want to get an indication as to how offerors would propose to handle these topics. In Attachment 1, (Packaging and Delivery of Proposals for Use with eCPS), page 88, we indicated that the technical proposal shall not exceed 200 pages (inclusive of all attachments).

Question 2 Attachment 4, Section 6, Project Management, The RFP references a “Monitoring Project Plan” Is this the same as a “Project Management Plan”, or is the requirement for an overall PM Plan in addition to a standalone Monitoring Plan?

Response to Question 2 The solicitation (including Attachment 3, Statement of Work, and Attachment 4, Additional Technical Proposal Instructions) has been revised to replace the term “Monitoring Project Plan” with “Project Management Plan” and delete the term “Monitoring Project Plan” (see revised Attachments 3 and 4, included with this amendment).

Question 3 In Section 14, on Page 58, the RFP notes the following information “shall be addressed in a separate section of the Business Proposal entitled “Information Security”. Please confirm which specific Information Security Requirements should be included in this section (i.e. FIPS 199 Assessment, IT Risk Assessment, IT System Security Plan)? Please also confirm the Business Proposal is the correct proposal to submit these items and not the Technical Proposal (as the technical proposal page limit would probably need to be increased if they are to be included in that volume).

Response to Question 3 As stated on page 58 of the RFP, under Section 14, Information and Physical Access Security, the information shall be addressed in a separate section of the Business Proposal entitled “Information Security”. The section provides very specific details regarding what is to be provided as part of your proposal and what is required upon/after award. However, the entire section must be addressed in your proposal.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 3

Question 4 Can DAIDS provide a list of the current data collection systems being used?

Response to Question 4 There are several systems in use by the Network Data Management Centers and non-network investigator initiated projects. Current systems include, but are not limited to, DataFax, iDatafax, Medidata, and OpenClinica. Investigator-initiated projects can choose what type of data collection system will be used and systems may range from a simple Access database to an EDC system. The Network sites use the data management system specified by their respective Network DMC(s) (i.e. DataFax and iDataFax for HVTN), but how sites operationalize the system may be different. For example, iDataFax and Medidata systems are EDC (electronic data capture) systems. Ideally sites should be entering the clinical data directly from their source documents into the electronic case report forms (eCRFs) in the EDC system, but many sites transcribe the data from the source document to a paper print out of the eCRF, and then transcribe the data from the paper CRF to the EDC system eCRF. Based on site implementation of a data management system, the monitoring may be done via the EDC system or through review of paper CRFs.

Question 5 Regarding Attachment 4, Section 5, item 4 (Page 106), do the established Network Sites and Investigator Initiated Sites have established secure connectivity for data entry and accommodating monitors?

Response to Question 5 The NIAID Clinical Research Management System (N-CRMS) Team is not aware of the security or computing infrastructure configurations at the sites, or if the monitors use the connectivity at the sites. However, the NIAID CRMS application is HTTPS-enabled and only HTTPS connections are allowed to access the NIAID CRMS application.

Question 6 Attachment 4, Section 8, item 4 (second paragraph, Page 109), we interpret this requirement to say that the contractor’s response should describe how we will perform a market survey/analysis of alternatives and provide a recommendation to the government, rather than proposing the actual tool in our response. Please confirm.

Response to Question 6 If the offeror has experience with using a specific tool or has developed a tool that would meet the needs of the Government, as defined in the SOW and Technical Proposal Instructions, that approach can be proposed. However, please be aware that the offeror must propose and budget for the actual tool itself, since this is a requirement of the Statement of Work (Option 28 is the development phase, and Options 29-33 are the maintenance phase), and the proposed tool will be evaluated and included in any subsequent award.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 4

Question 7 Regarding Attachment 5, Section 5 (Page 119), what documentation from Section L is required for Section 5 of the Business Proposal?

Response to Question 7 Please be aware that Attachment 5, (Additional Business Proposal Instructions and Uniform Cost Assumptions), Section 5 (Page 119), “TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION L OF THE SOLICITATION”, explains that a table of contents is required for the Business Proposal, and refers offerors to Section L.2.c., Business Proposal Instructions of the Solicitation (beginning on page 71 of the solicitation), for documentation requirements. All relevant documentation shall be included in a clearly marked section of the proposal.

Question 8 Regarding Attachment 4, Section 5, item 4 (Page 106), will the Government provide any Government Furnished Equipment (GFE)/ IT equipment?

Response to Question 8 As stated in Attachment 5, Additional Business Proposal Instructions, Section 3, Item 5) (on page 4 of the attachment/page 114 of the solicitation), no Government Furnished Property is offered for this acquisition. The purchase of Government Furnished Property will not be authorized as a direct charge under the resultant contract.

Question 9 Regarding Attachment 5, Section 4 (Pages 114-119 of the solicitation), we are assuming that pricing for the Base Period and Options 1-6, should be provided in a separate workbook from the optional quantities for FTE increases as well as optional quantities related to the risk-based monitoring tools. Please confirm.

Response to Question 9 Correct, pricing shall be provided in separate excel workbooks, as follows:

Base Period and Term Options 1-6;

Options 7-8, 10-11, 13-14, 16-17, 19-20, 22-23 and 25-26;

Options 9, 12, 15, 18, 21, 24, and 27;

Option 28; and

Options 29-33.

However, an overall summary spreadsheet should also be included, which shows the Base Period and Options 1-33. Please also refer to Attachment 13, Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet on page 42 of the solicitation, under Business Proposal Attachments.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 5

Question 10 Regarding Part 1, Section C (Page 12), for deliverable #16 (Final Initial Transition Plan), the RFP says it is due, “Not later than 4 weeks after receipt of COR comments on Draft Initial Transition Plan”.

This conflicts with Attachment 3: SOW, page 10, where it states: “Revise the Draft Initial Transition Plan, in order to accommodate COR comments, and submit the Final Initial Transition Plan to the COR and Contracting Officer not later than six (6) weeks after receipt of the COR’s comments regarding the Initial Transition Plan”.

We assume the Government requires the Final Initial Transition Plan no later than four weeks after receipt of COR comments on the draft plan to allow adequate time to implement the transition plan. Please confirm.

Response to Question 10 By virtue of this amendment, Attachment 3, Statement of Work, section 3), paragraph E., subparagraph 1., Initial Transition, item c. (on page 10 of the attachment), has been revised to read as follows (see revised Attachment 3, Statement of Work, included with this amendment):

Revise the Draft Initial Transition Plan, in order to accommodate COR comments, and submit the Final Initial Transition Plan to the COR and Contracting Officer not later than four (4) weeks after receipt of COR’s comments regarding the Draft Initial Transition Plan.

Question 11 Regarding Part 1, Section C (Pages 11 & 12), the SOW in Section E.1.refers to a “Monitoring Project Plan”, however, the table of deliverables only refers to a “Project Management Plan”.

Are the Project Management Plan and the Monitoring Project Plan the same document?

Response to Question 11 Please see our response to Question 2, above.

Question 12 Regarding Attachment 3 (SOW), Section D.2.a. (page 8 of the attachment/page 97 of the solicitation), the SOW states that the Contract Initiation Meeting will take place within 30 days of the effective date of the contract. However, Attachment 5, page 4, says for the contract initiation meeting we should assume “one meeting in Rockville, MD, within 2 months after the effective date of the contract to discuss contract initiation.”

Would the Government please confirm whether the contract initiation meeting will occur within 30 days or two months?

Response to Question 12 The intent of the Government is that the Contract Initiation Meeting shall be held in Rockville, Maryland, within thirty (30) days of the effective date of the contract.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 6

As a result of the foregoing, and by virtue of this amendment, Attachment 3, Statement of Work, Section 3), paragraph D., subparagraph 2., item a., Contract Initiation Meeting, is revised to read as follows (see revised Attachment 3, Statement of Work, included with this amendment):

Contract Initiation Meeting

Within thirty (30) days of the effective date of the contract, all key personnel shall participate in a one-day Contract Initiation Meeting with the COR, the Contracting Officer, and other DAIDS staff (as designated by the COR), to be held in Rockville, Maryland. The purpose of the Contract Initiation Meeting shall be to orient the Contractor to NIAID contract procedures, discuss Initial Transition plans, review the status of recruitment and hiring of site monitors, and review current and upcoming clinical site monitoring assignments. The Contractor shall develop the agenda and provide a meeting summary to all participants.

As a result of the foregoing, and by virtue of this amendment, Attachment 5, Additional Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, paragraph 2), Technical Cost Assumptions for Meetings – (Including Associated Travel), item a., Contract Initiation Meeting, is hereby revised to read as follows (see revised Attachment 5, Additional Business Proposal Instructions, included with this amendment):

Contract Initiation Meeting: Assume one meeting in Rockville, Maryland, within thirty (30) days of the effective date of the contract, to discuss contract initiation. Assume this meeting will require a two-night stay and shall be attended by all of the Contractor’s key personnel.

Question 13 Attachment 5, Section 3 (Page 114), Network Meetings: Attachment 5 instructs bidders to assume 4 4-day network meetings in Washington, DC, and 1 3-day network meeting in South Africa. However, Attachment 3 (SOW), does not mention “network meetings” in the Meetings and Teleconferences Section starting on page 8.

Would the Government provide clarification on what these “network meetings” entail?

Response to Question 13 Attachment 3, Statement of Work, section 3), paragraph D., item 2., Meetings and Teleconferences, is hereby revised by virtue of this amendment, in order to incorporate item d., Network Meetings, which shall read as follows (see revised Attachment 3, Statement of Work, included with this amendment):

Network Meetings:

The Contractor shall plan to attend annual network scientific meetings organized by the DAIDS- Funded HIV/AIDS Clinical Trial Networks. The meetings will be held both domestically and internationally. The purpose of the meetings is to obtain information on current and proposed studies and any scientific advances. The Contractor attendees may also be asked to provide a presentation to the network attendees on pertinent monitoring information.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 7

Question 14 Attachment 4, Section 6, last paragraph (Page 107), Instructions state: “Identify overall project plans developed and implemented over the past 3 years for projects of similar scope, size and complexity; describe problems encountered in implementing such plans and actions taken to overcome or minimize identified problems, including modifications to overall project plans.”

Due to the page limitations of the proposal, we assume the Government is requesting references to such contracts, please confirm.

Response to Question 14 Please refer to General Instructions to Offerors, Item # 13, Page 57, which outlines the information to be provided as part of Past Performance.

Question 15 Article C.2. #5 (Page 11), To ensure continuity of current monitoring efforts, we assume during the initial transition, all current SOPs and processes will be transferred to the contract recipient and updated as necessary. Please confirm.

Response to Question 15 As stated in the Attachment 3, Statement of Work, section 3), paragraph E., subparagraph 1., Initial Transition, item a. (on page 9 of the attachment/page 98 of the solicitation), contract materials and plans currently in use by the incumbent contractor shall be provided to the Contractor within fifteen (15) business days of the effective date of the contract. This includes SOPs, project management and staffing plan, as described in the Monitoring Project Plan, QA/QC plan, Training Plan, and overall monitoring strategy. Site monitoring visit reports and other monitoring materials shall be available to the Contractor through the N-CRMS or, if necessary, through an alternate NIAID/DAIDS clinical research system, as directed/specified by the COR.

Question 16 Attachment 5, (Page 113), “Distribution of Site Visits Trips”, we assume travel to and from clinical sites is not accounted for in “on-site days”. Please confirm.

Response to Question 16 That is correct; travel to and from clinical sites is not accounted for in the number of “on-site” days.

Question 17 L.2.B.1.b.1 (Page 69), and Attachment 4, Section 4 A&B (Page 105), in Attachment 4, the Government identifies Project Director and Project Manager as two independent positions, but in Section L, only the Project Director is identified. Please confirm that both the Project Manager and Project Director are required key personnel.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 8

Response to Question 17 Yes, both the Project Director and Project Manager are considered as key personnel.

Question 18 L2.B.1b.4 (Page 70), we assume that, outside of the required positions of the Project Director and Project Manager, key personnel are at the discretion of the offeror. Please confirm.

Response to Question 18 Yes, the offeror may suggest other key personnel if those positions provide value/benefit to the project and the personnel proposed have suitable qualifications.

Question 19 Regarding Section L., item 2.B.1.b.4 (Page 70), we assume that resumes/CVs are only required for those individuals identified or deemed key. Please confirm.

Response to Question 19 Correct; as stated in the Section L., item 2.B.1.b.4 (on page 70 of the solicitation), resumes of all key personnel are required.

Question 20 Regarding Section L., item 2.B.1.b.3 (Page 69), offerors are asked to list additional personnel who will be employed full-time under this contract. Based on the nature of the role of Site Monitors (fluctuations in numbers and locations based on Government demands), we assume that Site Monitors would not necessarily be full-time equivalent on the project. We assume that, for the Additional Personnel requirement, the Government does not want a full list of all personnel on the contract. Please confirm.

Response to Question 20 Since this contract is for level of effort (with the exception of Option 28, which is a non-severable, completion type option), Offerors must identify all proposed positions and their respective effort under the contract, in order to ensure that they are providing the required level of effort for the Base Period and each severable option (Options 1-27 and 29-33).

Question 21 Sections H.13 (B) thru (E) (Pages 25-31), If Contractors and/or their Subcontractors are not accessing HHS systems or HHS sensitive data, can NIAID confirm that Sections H.13(B) – (E) are not applicable?

Response to Question 21 The Contractor will in fact be accessing NIH systems in order to perform the requirements of the contract. Therefore, the requirements of Article H.13. Information and Physical Access Security are applicable to this requirement.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 9

Question 22 Sections H.13 (B) thru (E), (Pages 25-31), HHSAR was revised recently and three of the provisions included in the solicitation (HHSAR 352.270-1, 352.270-2, and 352.270-3 as incorporated and implemented through H.13 (B) – (E) have been deleted. Accordingly, will these clauses be replaced with the standards included in NIST 800-171?

Response to Question 22 Article H.13. Information and Physical Access Security (beginning on page 24 of the solicitation) and Section L, paragraph 2., subparagraph a., item 14., Information and Physical Access Security (beginning on page 58 of the solicitation), have been revised to remove the HHSAR references only.

All other language/requirements associated with this article and item remain unchanged.

In addition, the solicitation is amended to revise the following:

ARTICLE B.2. ESTIMATED COST – OPTION, paragraph b., is revised to include appropriate completion type language for Option 28 (non-severable, cost-reimbursement, completion type option), and shall read as follows:

The fixed fee for the Base Period of this contract is $____ .

Regarding the Base Period and Options 1-27 and Options 29-33, the fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

Regarding Option 28, 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 Part II, ARTICLE I.1.

of this contract.

ARTICLE C.1. STATEMENT OF WORK, paragraph a., is revised to update the date of the Statement of Work (from November 12, 2015 to February 26, 2016), and shall read as follows:

Independently and not as an agent of the Government, the Contractor shall be required to 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, dated February 26, 2016, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 1., subparagraph a., item c., Type of Contract and Number of Awards, sub-item 2. (on page 49 of the solicitation), is hereby revised to distinguish Option 28 as a non-severable, cost-reimbursement, completion type option, and shall read as follows:

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 10

It is anticipated that the award from this solicitation will be a multiple-year Cost-Reimbursement type Level of Effort contract with a Term of 1 year with options to extend the term for an additional 6 years, with the exception of Option 28, which is considered a non-severable, cost-reimbursement, completion type option.

1., subparagraph a., item d., Level of Effort (beginning on page 49 of the solicitation), is hereby revised to read as follows:

The Government's requirement for the work set forth in the Statement of Work of this solicitation is 62.00 full time equivalents (FTEs) during the base year of the contract and each term option, if exercised. It is estimated that the FTEs are constituted as specified below and will be expended approximately as follows:

Base Period and Options 1-6 FULL TIME EQUIVALENTS (FTEs)

Labor Category

Base Period Yr 1

Option

Yr 2

Option

Yr 3

Option

Yr 4

Option

Yr 5

Option

Yr 6

Option

Yr 7 Project Director

1.00 1.00 1.00 1.00 1.00 1.00 1.00

Project Manager

1.00 1.00 1.00 1.00 1.00 1.00 1.00

Site Monitoring Managers

10.00 10.00 10.00 10.00 10.00 10.00 10.00

Site Monitors 42.00 42.00 42.00 42.00 42.00 42.00 42.00 Administrative Support & Coordination

8.00 8.00 8.00 8.00 8.00 8.00 8.00

Total 62.00 62.00 62.00 62.00 62.00 62.00 62.00 NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government’s estimate and should not be considered restrictive. Offerors should propose the labor mix that they consider most appropriate for satisfactory performance of the work.

OPTIONS FOR INCREASED LEVEL OF EFFORT - Additional 5 FTE's for Unanticipated Increases in Demand (Options 7-8, 10-11, 13-14, 16-17, 19-20, 22-23 and 25-26):

During the course of the contract, it may be necessary to increase the level of effort in order to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor’s activities, to be activated, at the discretion of the Government, as an Option. If the Government elects to exercise this Option, the Contractor shall provide an additional five (5) FTEs per option. Up to two options of this type may be exercised in any one year. These options are considered severable in nature. The period of performance of an Option for Increased Services will not

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 11

exceed the term of the base year or Option year in which the Option is exercised. It is estimated that the FTEs are constituted as specified below and will be expended approximately as follows:

Increased Level of Effort for Unanticipated Increases in Demand (Additional 5 FTEs/Option)

[Options 7-8, 10-11, 13-14, 16-17, 19-20, 22-23 and 25-26] FULL TIME EQUIVALENTS (FTEs)

Labor Category

Base Period Yr 1

Option

Yr 2

Option

Yr 3

Option

Yr 4

Option

Yr 5

Option

Yr 6

Option

Yr 7 Site Monitoring Managers

0.75 0.75 0.75 0.75 0.75 0.75 0.75

Site Monitors 4.00 4.00 4.00 4.00 4.00 4.00 4.00 Administrative Support & Coordination

0.25 0.25 0.25 0.25 0.25 0.25 0.25

Total 5.00 5.00 5.00 5.00 5.00 5.00 5.00 NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government’s estimate and should not be considered restrictive. Offerors should propose the labor mix that they consider most appropriate for satisfactory performance of the work.

OPTIONS FOR INCREASED LEVEL OF EFFORT - Additional 10 FTE's for Unanticipated Increases in Demand (Options 9, 12, 15, 18, 21, 24 and 27):

During the course of the contract, it may be necessary to increase the level of effort in order to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor’s activities, to be activated, at the discretion of the Government, as an Option. If the Government elects to exercise this Option, the Contractor shall provide an additional ten (10) FTEs per option. One option of this type may be exercised in any one year. These are considered severable in nature.

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. It is estimated that the FTEs are constituted as specified below and will be expended approximately as follows:

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Increased Level of Effort for Unanticipated Increases in Demand (Additional 10 FTEs/Option)

[Options 9, 12, 15, 18, 21, 24 and 27] FULL TIME EQUIVALENTS (FTEs)

Labor Category

Base Period Yr 1

Option

Yr 2

Option

Yr 3

Option

Yr 4

Option

Yr 5

Option

Yr 6

Option

Yr 7 Site Monitoring Managers

1.50 1.50 1.50 1.50 1.50 1.50 1.50

Site Monitors 8.00 8.00 8.00 8.00 8.00 8.00 8.00 Administrative Support & Coordination

0.50 0.50 0.50 0.50 0.50 0.50 0.50

Total 10.00 10.00 10.00 10.00 10.00 10.00 10.00 NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government’s estimate and should not be considered restrictive. Offerors should propose the labor mix that they consider most appropriate for satisfactory performance of the work.

OPTIONS FOR INCREASED LEVEL OF EFFORT - Additional 1 FTE for Maintenance of a Site Performance Risk-Based Monitoring Tool (Options 29-33):

Beginning in contract year 3 or 4 (depending on when the development phase is complete) and through contract year 7, the system would be in a “maintenance phase”, and the government may exercise options (Options 29-33) that are severable in nature, to support this maintenance.

Should the Government elect to exercise Options 29-33 (Maintenance), the Contractor shall provide resources for the increase in work volume by one (1) FTE for each option. The period of performance of an Option for Increased Services (Options 29-33) will not exceed the term of the Option year in which the Option is exercised. It is estimated that the FTEs are constituted as specified below and will be expended approximately as follows:

Increased Level of Effort for the Provision of a Site Performance Risk- Based Monitoring Tool

[Options 29-33 (For Maintenance – Additional 1 FTE/Option)] FULL TIME EQUIVALENTS (FTEs)

Labor Category

Base Period Yr 1

Option

Yr 2

Option

Yr 3

Option

Yr 4

Option

Yr 5

Option

Yr 6

Option

Yr 7 Programmer(s) 0.50 0.50 0.50 0.50 0.50 Database Administrator

0.25 0.25 0.25 0.25 0.25

Computer Systems Analyst

0.25 0.25 0.25 0.25 0.25

Total 1.00 1.00 1.00 1.00 1.00

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NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government’s estimate and should not be considered restrictive. Offerors should propose the labor mix that they consider most appropriate for satisfactory performance of the work.

1., subparagraph a., is hereby revised to incorporate item l., Estimate of Effort, in order to describe how Option 28 shall be treated, and shall read as follows:

Option 28 is considered a non-severable, cost-reimbursement, completion type option, which may be exercised during contract year 2 and may last up to two years. To assist you in the preparation of your proposal, the Government considers the effort to be approximately 2.00 Full Time Equivalents (FTEs) per year. The amount of effort and the labor mix are provided as an estimate. This information is furnished for the Contractor’s information only and is not to be considered restrictive for proposal purposes. The Contractor may propose the level of effort and labor mix deemed most appropriate for carrying out the completion of work associated with this option. It is estimated that the FTEs are constituted as specified below and will be expended approximately as follows:

Estimate of Effort for the Provision of a Site Performance Risk-Based Monitoring Tool

[Option 28 (For Development)] FULL TIME EQUIVALENTS (FTEs)

Labor Category

Base Period Yr 1

Option

Yr 2

Option

Yr 3

Option

Yr 4

Option

Yr 5

Option

Yr 6

Option

Yr 7 Programmer(s) 0.70 0.70 Database Administrator

0.65 0.65

Computer Systems Analyst

0.65 0.65

Total 2.00 2.00 NOTE: The estimate of effort and labor mix provided above is to assist you in the preparation of your proposal. The Government considers the effort to be approximately 2.00 Full Time Equivalents (FTEs) per year for completion of the work associated with this option. This information is furnished for the Contractor’s information only and is not to be considered restrictive for proposal purposes.

2., subparagraph c., item 3.b.c., Subcontracted Items (on page 73 of the solicitation), is hereby revised to reflect that the certified cost or pricing data threshold at FAR 15.403-4(a), has been increased by $100,000, from $650,000 to $750,000, and shall read as follows:

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 14

c. Subcontracted Items

Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the prime contract. For each subcontract over $750,000, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.404-3.

2., subparagraph c., item 6., Small Business Subcontracting Plan (on page 75 of the solicitation), is hereby revised to reflect that the Small Business Subcontracting Plan threshold at FAR 19.702, has been increased by $50,000, from $650,000 to $700,000.

As a result of the foregoing, the first paragraph under this item (on page 75 of the solicitation) has been revised to read as follows:

6. Small Business Subcontracting Plan

If the proposed contract exceeds a total estimated cost of $700,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the Solicitation, See SECTION J - LIST OF ATTACHMENTS, BUSINESS PROPOSAL ATTACHMENTS of this RFP for an example of such a plan.

As a result of the foregoing, sub-item d.9. (on page 77 of the solicitation), is revised to read as follows:

9. Assurances that the offeror will include in all subcontracts the contract clause

"Utilization of Small Business Concerns." Assure that all subcontractors, other than small businesses, in excess of $700,000 adopt a plan similar to the plan agreed upon by the offeror.

ATTACHMENT 3, STATEMENT OF WORK, SECTION 3), paragraph F., OPTIONS, is hereby revised as follows (see also revised Attachment 3, Statement of Work, attached to this amendment, which includes all revisions associated with this amendment):

Options 28 and 29, and 30-34– Increased Level of Effort for the Provision of a Site Performance Risk-Based Monitoring Tool, is hereby deleted in its entirety and replaced with the following:

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Options 28 and 29-33 – Provision of a Site Performance Risk-Based Monitoring Tool and Increased Level of Effort for Maintenance Phase:

Option 28 - Provision of a Site Performance Risk-Based Monitoring Tool - Development Phase:

During contract year 2, the government may exercise a non-severable option to support the development or adaptation of a commercially available system, in the N-CRMS or as a stand-alone system, in order to implement site performance risk-based monitoring (it is anticipated that the “development phase” may last up to 2 years). The system should provide the ability to identify and weigh key risk factors that may have the greatest impact on participant safety and data integrity, ability to define threshold levels for risk factors and “flag” sites (i.e. green-yellow-red system) that fall outside of pre-determined levels for high, medium and low risk. In addition, the system should provide “real-time” reports, to allow for the identification of site quality and compliance risks, so that objective decisions can be made regarding frequency, degree, and type of monitoring visits (i.e., remote or on-site) for clinical research sites. The system should be flexible enough to accommodate any changes in business processes, and provide a variety of reports. Once developed and ready for production, the application shall be hosted in the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) computing environment. The Contractor shall communicate and collaborate with the OCICB, in order to determine the requirements for data transfer, to ensure compatibility with the OCICB computing environment.

All IT systems development or enhancement tasks supported by the contractor shall follow the HHS Enterprise Performance Life Cycle (EPLC) framework and methodology. Information about EPLC policy and framework is available at http://www.hhs.gov/ocio/policy/2008- 0004.001.html and http://www.hhs.gov/ocio/eplc-lifecycle-framework.pdf.

Options 29-33 - Provision of a Site Performance Risk-Based Monitoring Tool - Maintenance Phase: Beginning in contract year 3 or 4 (depending on when the development phase is complete) and through contract year 7, the system would be in a “maintenance phase”, and the government may exercise options (Options 29-33) that are severable in nature, to support this maintenance. Should the Government elect to exercise Options 29-33 (Maintenance), the Contractor shall provide resources for the increase in work volume by one (1) FTE for each option. The period of performance of an Option for Increased Services (Options 29-33) will not exceed the term of the Option year in which the Option is exercised.

ATTACHMENT 4, ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS, SECTION 8,

item 4), is revised to read as follows (see also revised Attachment 4, Additional Technical Proposal Instructions, attached to this amendment, which includes all revisions associated with this amendment):

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 16

OPTIONS 28 and 29-33: Provision of a Site Performance Risk-Based Monitoring Tool and Increase Level of Effort for Maintenance Phase:

Provision of a Site Performance Risk-Based Monitoring Tool - Development Phase: During contract year 2, the government may exercise a non-severable option to support the development or adaptation of a commercially available system, in the N-CRMS or as a stand-alone system, in order to implement site performance risk-based monitoring (it is anticipated that the “development phase” may last up to 2 years). The system should provide the ability to identify and weigh key risk factors that may have the greatest impact on participant safety and data integrity, ability to define threshold levels for risk factors and “flag” sites (i.e. green-yellow-red system) that fall outside of pre-determined levels for high, medium and low risk. In addition, the system should provide “real-time” reports, to allow for the identification of site quality and compliance risks, so that objective decisions can be made regarding frequency, degree, and type of monitoring visits (i.e., remote or on-site) for clinical research sites. The system should be flexible enough to accommodate any changes in business processes, and provide a variety of reports. Once developed and ready for production, the application shall be hosted in the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) computing environment.

The Contractor shall communicate and collaborate with the OCICB, in order to determine the requirements for data transfer, to ensure compatibility with the OCICB computing environment.

The potential use of a Commercial Off-the-Shelf (COTS) application shall be considered and a proposal to include any required COTS customization, followed by maintenance efforts must be submitted to the Government. The proposal must include all aspects of advantages, disadvantages, returns on investment, etc. to prove that using a COTS product shall meet the requirements of the Site Performance Risk-Based Monitoring Tool and shall provide the most total cost effective solution. All data rights listed above shall apply to the use of the COTS tool.

In addition, the COTS proposal must include the ability to operate the Site Performance Risk- Based Monitoring Tool without requiring additional software licenses in the event that the Government determines that continued use of the COTS application is not cost effective or does not meet the needs of the Government. It may be necessary to have compiled source code (or other object code) of the COTS application in order to continue utilizing data for generating reports.

Development Phase (Option 28): During contract years 2 and/or 3, the government may exercise a non-severable option (Option 28), in order to support the development or adaptation of a commercially available system, in the N-CRMS or as a stand-alone system, in order to implement site performance risk-based monitoring (it is anticipated that the “development phase” should last approximately 1-2 years).

Discuss approach to support development or adaptation of a commercially available system to implement a site performance risk-based monitoring tool to allow for systematic analysis of

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 17

monitoring findings to support decisions for changes to site monitoring frequency. Again, we anticipate that the development and implementation of this system will take 1-2 years and will then shift to a maintenance phase.

Provide:

a. Description of processes and tools to implement site assessment risk-based methodology.

b. Develop standardized criteria/factors to determine whether site is high, medium or low risk

c. Methods and standards used for identification of high and low risk sites for changes in monitoring requirements.

d. Description of process to address issues with high risk sites, such as root cause analysis, development and implementation of site performance improvement plan, enhanced frequency of monitoring, etc.

e. Description of process to identify low risk sites and adjustment of monitoring requirement.

f. Track information in a commercially available database system that has the capability to interface with the N-CRMS system or an alternate DAIDS Clinical Research Management system.

g. Develop reports to inform objective monitoring decision-making

h. Develop SOP to guide the clinical site and study monitoring process.

i. Description of roles and responsibilities as well as any required resources for interactions in and maintenance of the system.

Maintenance Phase (Options 29-33): Beginning in contract year 3 or 4 (depending on when the development phase is complete) and through contract year 7, the system would be in a “maintenance phase”, and the government may exercise options (Options 29-33) to support this maintenance. Should the Government elect to exercise Options 29-33 (Maintenance), the Contractor shall provide resources for the increase in work volume by one (1) FTE for each option. The period of performance of an Option for Increased Services will not exceed the term of the Option year in which the Option is exercised.

Discuss approach to maintain the system used for the site performance risk-based monitoring tool to allow for systematic analysis of monitoring findings to support decisions for changes to site monitoring frequency.

Provide:

a. Description of the process for generating reports on agreed upon frequency to identify key indicators that consistently influence a site’s risk ranking across all protocols at a site to assist DAIDS staff with decisions regarding monitoring frequency and intensity.

b. Description of the process for re-assessing key quality indicators used for risk ranking of sites (green, yellow, and red) to ensure associated weight remains valid.

c. Description of the process for yearly evaluation of criteria and tools used to ensure risk ranking aligns with actual site performance.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 18

ATTACHMENT 5, ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS, SECTION 4 -

OPTIONS, Options for the Provision of a Site Performance Risk-Based Monitoring Tool and Maintenance Phase have been revised to combine the original development Options 28 and 29 into one non-severable, cost-reimbursement completion type option (Option 28). As a result, the maintenance options (originally numbered as Options 30-34) are now renumbered as Options 29- 33 (these maintenance options are considered severable, cost-reimbursement, level of effort, term type options). Based on the foregoing, the corresponding language related to these options have been revised to read as follows (see also revised Attachment 5, Additional Business Proposal Instructions, attached to this amendment, which includes all revisions associated with this amendment):

Options 28 and 29-33: Provision of a Site Performance Risk-Based Monitoring Tool and Increase Level of Effort for Maintenance Phase:

Option 28 – Provision of a Site Performance Risk-Based Monitoring Tool – Development Phase: During contract year 2, the government may exercise a non-severable option to support the development or adaptation of a commercially available system, in the N-CRMS or as a stand-alone system, in order to implement site performance risk-based monitoring (it is anticipated that the “development phase” may last up to 2 years). The system should provide the ability to identify and weigh key risk factors that may have the greatest impact on participant safety and data integrity, ability to define threshold levels for risk factors and “flag” sites (i.e. green-yellow-red system) that fall outside of pre-determined levels for high, medium and low risk. In addition, the system should provide “real-time” reports, to allow for the identification of site quality and compliance risks, so that objective decisions can be made regarding frequency, degree, and type of monitoring visits (i.e., remote or on-site) for clinical research sites. The system should be flexible enough to accommodate any changes in business processes, and provide a variety of reports. Once developed and ready for production, the application shall be hosted in the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) computing environment. The Contractor shall communicate and collaborate with the OCICB, in order to determine the requirements for data transfer, to ensure compatibility with the OCICB computing environment.

Option 28 is considered a non-severable, cost-reimbursement, completion type option, which may be exercised during contract year 2 and may last up to two years. To assist you in the preparation of your proposal, the Government considers the effort to be approximately 2.00 Full Time Equivalents (FTEs) per year. The amount of effort and the labor mix are provided as an estimate. This information is furnished for the Contractor’s information only and is not to be considered restrictive for proposal purposes. The Contractor may propose the level of effort and

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 19

labor mix deemed most appropriate for carrying out the completion of work associated with this option.

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

Option 28 Option 28

2 FTEs 2 FTEs

Estimate of Effort for the Provision of a Site Performance Risk-Based Monitoring Tool [Option 28 (For Development)]

FULL TIME EQUIVALENTS (FTEs)

Labor Category Base Period Yr 1

Option 1 Yr 2

Option 2 Yr 3

Option 3 Yr 4

Option 4 Yr 5

Option 5 Yr 6

Option 6 Yr 7

Programmer(s) 0.70 0.70

Database Administrator

0.65 0.65

Computer Systems Analyst

0.65 0.65

Total 2.00 2.00

NOTE: The estimate of effort and labor mix provided above is to assist you in the preparation of your proposal. The Government considers the effort to be approximately 2.00 Full Time Equivalents (FTEs) per year for completion of the work associated with this option. This information is furnished for the Contractor’s information only and is not to be considered restrictive for proposal purposes.

Options 29-33 - Provision of a Site Performance Risk-Based Monitoring Tool - Maintenance Phase: Beginning in contract year 3 or 4 (depending on when the development phase is complete) and through contract year 7, the system would be in a “maintenance phase”, and the government may exercise options (Options 29-33) that are severable in nature, to support this maintenance. Should the Government elect to exercise Options 29-33 (Maintenance), the Contractor shall provide resources for the increase in work volume by one (1) FTE for each option. The period of performance of an Option for Increased Services (Options 29-33) will not exceed the term of the Option year in which the Option is exercised. The following tables provide a breakdown of Options per year and the anticipated level of effort for each:

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 20

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

Option 29 Option 30 Option 31 Option 32 Option 33

1 FTE 1 FTE 1 FTE 1 FTE 1 FTE

Increased Level of Effort for the Provision of a Site Performance Risk-Based Monitoring Tool [Options 29-33 (For Maintenance – Additional 1 FTE/Option)]

FULL TIME EQUIVALENTS (FTEs)

Labor Category

Base Period Yr 1

Option 1 Yr 2

Option 2 Yr 3

Option 3 Yr 4

Option 4 Yr 5

Option 5 Yr 6

Option 6 Yr 7

Programmer(s) 0.50 0.50 0.50 0.50 0.50

Database Administrator

0.25 0.25 0.25 0.25 0.25

Computer Systems Analyst

0.25 0.25 0.25 0.25 0.25

Total 1.00 1.00 1.00 1.00 1.00

NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government’s estimate and should not be considered restrictive. Offerors should propose the labor mix that they consider most appropriate for satisfactory performance of the work.

1) Technical Cost Assumptions

The following General Cost Assumptions apply to all Options:

a. Assume all airfare to be economy class.

b. Assume hotel and per diem at US government rates for the applicable city/location.

NEED:

For costing Option 28 for Estimate of Effort, for the Provision of a Site Performance Risk- Based Monitoring Tool – Development Phase please assume the following:

Initial 3 hour meeting at NIAID offices in Rockville, MD, to discuss development or adaptation of a commercially available system to assess site performance using standardized criteria.

AMENDMENT #1 RFP NIAID-DAIDS-NIHAI2015045 21

Monthly teleconference calls for the first 6 months of Year 2, after exercise of Option 28, including additional calls, on an ad-hoc basis, if needed or as required by the COR.

After implementation of the tool, quarterly updates to be provided during Quarterly Progress Review Meetings.

Reports of site performance status to be provided quarterly. Report format to be discussed at initial meeting.

For costing Options 29-33 for Increased Level of Effort for the Provision of a Site Performance Risk-Based Monitoring Tool – Maintenance Phase, please assume the following:

Monthly teleconference calls for the first 3 months after exercise of the first option for maintenance (Option 29-33) to ensure a smooth transition to the maintenance period, including additional calls, on an ad-hoc basis, if needed or as required by the COR.

During the maintenance period quarterly updates to be provided during Quarterly Progress Review Meetings.

Reports of site performance status to be provided quarterly.

END OF AMENDMENT NO. 1, RFP No. NIAID-DAIDS-NIHAI2015045

Statement of Work ATTACHMENT 3 February 26, 2016

ATTACHMENT 3: STATEMENT OF WORK

NIAID CLINICAL SITE MONITORING

RFP No. NIAID-DAIDS-NIHAI2015045

1) BACKGROUND AND INTRODUCTION

The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to increase the knowledge of the pathogenesis and transmission of HIV, to support the advancement of therapies for HIV infection and its complications, and to support the development of HIV/AIDS vaccines and other prevention measures.