Revised - ATTACHMENT 6-AddTechPropInst_30MAR2020.pdf

RFP Clinical Central Laboratory Services

Additional Technical Proposal Instructions 1OCT2019

RFP-NIAID-DMID-75N93020R00004

ATTACHMENT 5

ATTACHMENT 6: ADDITIONAL TECHNICAL PROPOSAL

INSTRUCTIONS, FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF

CONTENTS

CLINICAL CENTRAL LABORATORY SERVICES

RFP-NIAID-DMID-75N93020R00004

TECHNICAL PROPOSAL – TABLE OF CONTENTS

SECTION 1:

A. PROPOSAL TITLE PAGE Include RFP title and number, name of organization, DUNS number, date of proposal, and identify if the proposal is an original or a copy.

B. PROJECT OBJECTIVES

C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

D. TABLE OF CONTENTS

SECTION 2: TECHNICAL PROPOSAL OVERVIEW

(suggested 2 page maximum – included in total page limitation)

Provide a brief overview of the Technical Proposal, including the following:

A. A brief description of the activities to be performed by the Offeror and all proposed subcontractors to include: identification of all proposed subcontractors; a listing of all

It is strongly recommended that offerors use the following template as the

Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the RFP and provide specific instructions and formatting for the Technical Proposal. While Section L.2.b. of the RFP provides a generic set of Technical Proposal instructions applicable to all NIH R&D and non R&D solicitations, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal. Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the Statement of Work, Task Order

Statement of Work, all reference materials, and attachments, the Technical Evaluation

Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

Offerors must refer to the RFP Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, (this entire Technical Proposal is 10 pages, not including the response to sample Task

Orders), formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

RFP-NIAID-DMID-75N93020R00004

key personnel for the Offeror and the proposed subcontractors; and a Curriculum Vitae with degrees, titles and roles in the project.

B. A brief description of the facilities and equipment to be made available by the Offeror and all proposed subcontractors.

SECTION 3: TECHNICAL REQUIREMENTS

In addition to the information provided in Section L, Offerors should demonstrate their capabilities to fulfill the activities specified in the Statement of Work.

A. TECHNICAL REQUIREMENTS

1. Describe your clinical sample retention and retesting procedures.

2. Explain the hours and frequency of courier service throughout the week, holidays and weekends. Provide courier metrics pertaining to successful on-time pick-up and delivery of safe specimens and processes and procedures to limit breakage and the receipt of non-usable specimens. Describe your plans to control temperature during shipment of clinical specimens and to ensure that specimens are received in a within 24 hours of pick-up.

3. Provide copies of all required local, state, and federal certifications.

4. Describe your Quality Control process for electronic data transfers.

5. Describe the assay/platform used, data format reported (including the exact number of decimal places and any special characters that may be used), reference ranges, location of where tests will be performed and if a subcontractor will perform the work. Indicate if a confirmation test is required and the turn-around time for reporting test results for the following tests.

• Hematology

• Chemistry

• Amylase/Lipase

• Serum pregnancy

• Urinalysis

• HIV

• Hepatitis B

• Hepatitis C

• Drug testing

• Gonorrhea

• Chlamydia

• Creatine Phosphokinase

6. Describe quality management and standardization of equipment, processes, controls and calibration.

B. OVERALL ADMINISTRATION AND PROJECT MANAGEMENT SUPPORT

Describe, in detail, the processes and procedures for overall Project Management, including project organization and management as it applies to the subcontracting, RFP-NIAID-DMID-75N93020R00004 planning, initiation, implementation, integration, conduct, and monitoring for completing the activities indicated in the Statement of Work and represented in the

Sample Task Order.

1. Describe the project management systems that will be used to track activities and to keep multiple projects on time and within budget, including a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of task order requirements, including subcontractors.

2. Describe relevant organizational experience, problems or obstacles encountered and approaches implemented to resolve or correct identified problems, including proposed subcontractors.

3. Outline how the Project Manager and staff will communicate with DMID and how the PM will communicate, monitor, and manage the project both internally and externally, including at subcontractor facilities. Provide a Communication and

Issue Escalation plan.

4. Describe your approach for soliciting, evaluating, negotiating, awarding, managing, remediating problems and terminating subcontracts in accordance with Federal regulations.

5. Provide a timeline from receipt of request for services to study-start that includes a final spec sheet, approved budget, award of task order, final data transfer agreement, final investigator manual and requisitions, final slides for investigator training, investigator training, results database complete, test data transfer complete, supplies received on site.

6. Describe your capacity to respond in a pandemic situation. From Request of

Services to Study Start, your responses must include a standard response time and an emergency response time.

7. Describe your capacity to work with international sites.

C. FACILITIES, EQUIPMENT, AND OTHER RESOURCES

1. Describe the availability and adequacy of safe facilities, equipment, space and other resources necessary to carry out the Statement of Work, including any proposed subcontractors’ ability, with:

• Processing and storage of clinical specimens

• Shipment of specimens in accordance with IATA standards and in compliance with temperature monitoring

2. Describe your current set-up for processing clinical specimens from multi-center clinical studies, as follows:

• Describe the location(s) of your laboratories, responses should include at least one lab located within the US.

• Describe if all locations use the same methodology of testing and if they are linked to the same data systems.

• Are laboratory locations regionally based or is there one central laboratory that tests samples for clinical studies?

RFP-NIAID-DMID-75N93020R00004

SECTION 4: SCIENTIFIC AND TECHNICAL PERSONNEL

Provide information relevant to document individual training, experience, qualifications and expertise necessary for the successful completion of all contract requirements. Limit CVs to 1-2 pages and limit references for publications to the scope of the contract.

Key Scientific and Technical Personnel:

Describe the experience, training, and qualifications, as well as the level of effort, for all proposed key scientific and technical personnel and subcontractors.

SECTION 5: OTHER CONSIDERATIONS

Section L of the RFP provides minimum documentation requirements for the following items:

The required information described in Section L should be assembled together, in the following clearly marked sections of the Technical Proposal. Refer to Section L of the RFP for specific requirements. Read each section below carefully. In some cases, offerors may be asked to provide documentation in addition to the minimum requirements identified in Section L.

1) Response to Task Order

For each proposal to Task Order (including samples) provide the following:

• Reference Ranges for each test requested

• List of what is included in each collection kit

• Investigator manual

• Lab requisitions

• Timeline

• Budget

2) Information Technology (IT) Systems Security

Section L of the RFP specifies the minimum documentation requirements for IT Systems security. All related documentation should be included in the Technical Proposal in a clearly marked section. The Technical Proposal shall include a plan for IT Systems security, as required by this RFP.

3) Biological Agents or Toxins

The Technical Proposal must include a plan for biohazard safety and security requirements.