75N91020R00042 - Amendment 0001 Signed.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Jame Chang, Contracting Officer

The purpose of this amendment is to provide responses to questions received

The changes referenced above are attached and Attachments 21 and 22 are included with this amendment.

National Cancer Institute Office of Acquisitions NCI Shady Grove 9606 Medical Center Drive, MSC 9705 Rockville, MD 20850-9705

75N91020R00042

1 14

10/26/2020

10/26/2020

75N91020R00042 Amendment 0001

RFP: 75N91020R00042

Amendment 0001

I. Questions and Answers

Q1: Solicitation page 11, INFORMATION AND/OR PHYSICAL SECURITY ACCESS SECURITY - This section indicates a Level 5; Public Trust - Moderate Risk is required. Article H.9. Section E. Position Sensitivity Designations reflects Level 1 on page 31. Page 60 also designates Level 1 under the INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY section. Will the Government change the Level 5 on page 11 to Level 1 to be consistent?

NCI Response: All contractor employees must obtain a Level 1 - Non-Sensitive as reflected in Page

60. Page 11 will be updated to reflect this value.

Q2: Position Sensitivity Designations (RFP page 11) - The RFP classifies contractor employees as Level 5 (Public Trust – Moderate Risk). On page 31 this classification is identified as Level 1 (Non- Sensitive). Please clarify.

NCI Response: All contractor employees must obtain a Level 1 - Non-Sensitive as reflected in Page

60. Page 11 will be updated to reflect this value.

Q3: Article F.3. Level of Effort (RFP page 17) - The RFP specifies that the labor hour requirement will be met if not less than 90% nor more than 110% of the direct labor hours are furnished. On page 90 of the RFP these thresholds are 85% and 110%. Please clarify.

NCI Response: Page 90 is correct. The labor hour requirement will be met if not less than 85% nor more than 110% of the direct labor hours. Page 17 will be corrected.

Q4: Solicitation, Section L, b.5. Additional Technical Proposal Instructions, page 73 - The additional instructions state "…to limit the total number of pages for the entire proposal to 35 pages."

Attachment 1, II.B. states the "…Technical proposal shall not exceed 35 pages." Will the Government confirm the 35-page limit on page 73 excludes the Business Proposal?

NCI Response: The 35-page limit is specific only to the technical proposal. There is no page limit for the business proposal.

Q5: Solicitation, Technical Proposal - Table of Contents, page 73 - Solicitation, Section L, b.5.

Additional Technical Proposal Instructions, page 73 states the outline of the proposal shall be IAW

Amendment 0001 page 67 of the RFP. Technical Proposal - Table of Contents on page 73 provides a different outline numbering and titles. Will the Government clarify the required outline for the Technical Proposal?

NCI Response: Offerors shall follow the outline in accordance with the Additional Technical Proposal Instructions on page 73.

Q6: Additional Technical Proposal Instructions (RFP page 73) - The RFP states that “the outline/order of the proposal shall be in accordance with page 67 of the RFP entitled ‘b. Technical Discussions.’” The outline/order described on page 67 differs considerably from the additional technical proposal instructions and the evaluation factors for award and omits certain required information (such as organizational experience). Will the Government allow offerors to format their technical proposal consistently with the additional technical proposal instructions and the evaluation factors for award, rather than the outline/order described on page 67 of the RFP?

NCI Response: Offerors shall follow the outline in accordance with the Additional Technical Proposal Instructions on page 73. The Additional Technical Proposal Instructions align with the Technical Evaluation Factors on page 91.

Q7: Solicitation, Section L, b.5.A Additional Technical Proposal Instructions, Personnel page 74 -The first paragraph states "Describe the experience, qualifications and availability of all personnel who will be assigned for direct work on this project"; and subsequent position description requires names and resumes. Will the Government remove the requirement to provide names (along qualifications, experience, accomplishments or expertise) for positions not designated as key?

NCI Response: Offerors shall provide a summary of all the names of proposed personnel along with their qualifications as part of a narrative. Paragraph c will be updated for clarification

Q8: Evaluation Of Electronic And Information Technology Accessibility - Section 508 (RFP page 93) - May the Section 508 Product Assessment Template be provided as an appendix to the technical proposal, and not counted in the page limitation?

NCI Response: The completed 508 Product Asessment Template (VPAT) will not be counted against the 35 page limit for the technical proposal.

Q9: Solicitation, Section L, b. Technical Proposal Instructions page 68-69- Section 1. Technical Discussions, b. Personnel, 1 and 2 require the names (and/or that the personnel be listed), qualifications, experience and accomplishment of the Single Principal Investigator/Project Director and other investigators, respectively; 3. Additional Personnel requires names and specific items or expertise; and 4. Resumes requires resumes for all key personnel. Will the Government remove the requirement to provide names (along qualifications, experience, accomplishments or expertise) for positions not designated as key?

Amendment 0001

NCI Response: The key personnel for this contract are the Program Manager and Deputy Program Manager labor categories. Resumes will only be required for these labor categories. This will be clarified on page 69. See response to Q7 for the response to providing names for non-Key personnel.

Q10: Attachment 10 - May the Technical Proposal Cost Information/Summary of Labor and Direct Costs be included as an appendix to the technical proposal, and not counted in the page limitation?

NCI Response: The completed Technical Proposal Cost Summary template will not be counted against the 35-page limit for the technical proposal.

Q11: Attachment 11 - Question: Should the Summary of Related Activities be provided with the technical or business proposal? If required with the technical proposal, may it be included as an appendix and not counted in the page limitation?

NCI Response: The completed Summary of Related Activities form must be included in the technical proposal. It will not be counted against the 35-page limit for the technical proposal.

Amendment 0001

II. Revisions to Sections of the RFP:

Page 11 – ARTICLE C.2. REPORTING REQUIREMENTS - POSITION SENSITIVITY DESIGNATIONS, the positional sensitivity designation level which applies to this solicitation/contract has been unselected and replaced with the following:

Unselected:

Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

Replaced with:

Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

Page 17 - ARTICLE F.3. LEVEL OF EFFORT, paragraph b. is deleted and replaced with the following:

Deleted:

The Contractor shall have satisfied the requirement herein if not less than 90% nor more than 110% of the total direct labor Hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

Replaced With:

The Contractor shall have satisfied the requirement herein if not less than 85% nor more than 110% of the total direct labor Hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

Page 46 – SECTION J – LIST OF ATTACHMENTS, Attachments 21 and 22 are added as follows:

Attachment No. Title Location Attachment 21: Appendix I – Code of Conduct Please refer to the attachment at the end of the RFP.

Attachment 22: Return to Work Guidance Please refer to the attachment at the end of the RFP.

Page 69 – TECHNICAL PROPOSAL INSTRUCTIONS, II. Personnel, 4. Resumes is deleted and replaced with the following:

Deleted:

Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications

Amendment 0001

Replaced With:

Resumes of all key personnel (Program Manager and Deputy Program Manager) are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

Page 73 - Additional Technical Proposal , paragraph 3, is deleted and replaced with the following:

Deleted:

The outline/order of these instructions may be inconsistent with the "Technical Discussion" on page 67 of the RFP, but the outline/order of the proposal shall be in accordance with page 67 of the RFP entitled "b. Technical Discussions". However, please address all of the items discussed in these instructions in the proposal

Replaced With:

The outline/order of these instructions may be inconsistent with the "Technical Discussion" on page 67 of the RFP, but the outline/order of the proposal shall be in accordance with page 73 of the RFP entitled "b. Technical Discussions". However, please address all of the items discussed in these instructions in the proposal

Page 74 - Additional Technical Proposal Instructions, TECHNICAL PROPOSAL – TABLE OF CONTENTS SECTION 2, A. Personnel and Experience, is deleted and replaced with the following:

Deleted:

Describe the experience, qualifications and availability of all personnel who will be assigned for direct work on this project. Information is required which shows the composition of the task or work group, its general qualifications and recent experience with similar programs.

Each area of the Statement of Work shall be addressed in sufficient detail to permit evaluation of the proposal in terms of the adequacy and availability, as needed, of all staff to be assigned to the project. Indicate the approximate percentage of total time each could be made available for this contract and specifically to which tasks each employee would be assigned. Within the total level of effort offerors must indicate the specific level of effort which they consider appropriate for each function outlined in the Statement of Work.

Provide a Personnel Ranking Matrix which indicates the hierarchical line of supervisory authority and indicate which contractor employee(s) will perform the various tasks. State the estimated time to be spent on the project.

OFFERORS MUST ASSURE THAT THE PROJECT MANAGER, AND ALL OTHER PERSONNEL

PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE

THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED

THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME,

Amendment 0001

THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE

TIME COMMITMENT.

The Contracting Officer’s Representative (COR) will provide guidance on the specific work being performed, when needed, requested or as required by the Statement of Work.

The Contractor, however, shall be responsible for the management and supervision of all Contractor employees (including any subcontractor employees, if applicable) that are working under this contract.

Provide complete detailed resumes of the proposed personnel. Resumes shall include educational background and related experience. In particular, experience with clinical trials or biomedical environment shall be included. Include dates, places and names of previous employers, and any related training.

It is estimated that the following roles and responsibilities would be required to perform the contract:

a. Program Manager

In general, it is expected that the Program Manager shall possess relevant education and/or at least three years of management experience in the health care/clinical research fields. The CV of the individual must include all relevant education and any certifications earned. As the Program Manager shall be responsible for coordinating all Contractor activities pertaining to the work specified in the Statement of Work

(SOW), this individual must demonstrate self-motivation, superior project and personnel management, effective communication, organization and process improvement skills in the following but not limited areas:

● Knowledge and experience in clinical trials development processes (both scientific and administrative); and knowledge and experience within the oncology community.

● Overall management capabilities, which would permit the effective implementation of all tasks on the project, including demonstrated experience in supervising all efforts of the type to be conducted under the contract, including managing teams of health care professionals at all levels.

● Knowledge and experience with business improvement practices, which includes knowledge of quality control and quality assurance methods for all contract activities.

● Experience in dealing with health care professionals at all levels, including effective use of both verbal and written communication skills and ability to provide successful presentations to those professionals, including orientation of new staff members.

● Education and knowledge of medical terminology. (MS in Scientific Field strongly

Amendment 0001 preferred)

● Knowledge and experience with the development and administration of survey tools.

b. Deputy Program Manager

In general, it is expected that the Deputy Program Manager shall possess relevant education and/or management experience in the health care/clinical research fields.

The CV of the individual must include all relevant education and any certifications earned. As the Deputy Program Manager shall be responsible for assisting the Program Manager--and serving in the Program Manager’s capacity during the Program Manager’s absence-- in the coordination of all Contractor activities pertaining to the work specified in the Statement of Work (SOW), this individual must demonstrate self-motivation, superior project and personnel management, effective communication, organization and process improvement skills in the following but not limited areas:

● Extensive Knowledge and experience in clinical trials development processes

(both scientific and administrative aspects); and knowledge and experience within the oncology community.

● Extensive knowledge of processes and looking up information in several different databases along with email archives to track and follow up on protocol development.

● Overall management capabilities, which would permit the effective implementation of all tasks on the project, including demonstrated experience in supervising all efforts of the type to be conducted under the contract, including managing teams of health care professionals at all levels.

● Knowledge and experience with business improvement practices, which includes knowledge of quality control and quality assurance methods for all contract activities.

● Experience in dealing with health care professionals at all levels, including effective use of both verbal and written communication skills and ability to provide successful presentations to those professionals, including orientation of new staff members.

● Education and knowledge of medical terminology. (MS in Scientific Field strongly preferred)

● Knowledge and experience with the development and administration of survey tools

c. Document Specialists/Senior Document Specialists:

List the names of all Document Specialists who will be participating in the project.

Discuss the qualifications, experience, and accomplishments. State the estimated

Amendment 0001 time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.

In general, it is expected that the Document Specialists shall possess relevant education and/or experience in the health care/clinical research fields. The CV of these individuals must include all relevant education and any certifications earned. As the Document Specialists shall be responsible for performing the activities pertaining to the work specified in the Statement of Work (SOW), these individuals must demonstrate self-motivation, effective communication, organization and process improvement skills in the following but not limited areas:

● Knowledge and experience in clinical trials development processes

(both scientific and administrative aspects)

● Education and knowledge of medical terminology. (MS in Scientific Field strongly preferred)

● Experience in dealing with health care professionals at all levels, including effective use of both verbal and written communication skills and ability to assist in providing successful presentations to those professionals, including orientation of new staff members.

In addition, all resumes shall elaborate the following technical proficiency:

● Demonstrated experience with utilization of databases (including data element abstraction, milestone entry, generating queries and running canned reports), document management systems, the Internet, and Microsoft Office products;

● Knowledge and experience with the development and administration of

● Proficiency with Microsoft Office and SharePoint as well as Adobe Acrobat.

The offeror shall maintain a backup plan personnel system for key personnel and key positions. Provide a detailed description of how the contract performance will be maintained during fluctuations in the personnel needs as a result of high or low levels of work, etc. Also explain in detail the plan for maintaining performance during periods of extended absences by personnel (defined as greater than 10 consecutive working days). For personnel proposed as “backup” personnel to key positions, curriculum vitae or resumes must be provided.

Backups named must be thoroughly familiar with the position that they are supporting. The offeror shall demonstrate the availability of personnel proposed on the project.

Amendment 0001

Replaced With:

Describe the experience, qualifications and availability of all personnel who will be assigned for direct work on this project. Information is required which shows the composition of the task or work group, its general qualifications and recent experience with similar programs.

Each area of the Statement of Work shall be addressed in sufficient detail to permit evaluation of the proposal in terms of the adequacy and availability, as needed, of all staff to be assigned to the project. Indicate the approximate percentage of total time each could be made available for this contract and specifically to which tasks each employee would be assigned. Within the total level of effort offerors must indicate the specific level of effort which they consider appropriate for each function outlined in the Statement of Work.

Provide a Personnel Ranking Matrix which indicates the hierarchical line of supervisory authority and indicate which contractor employee(s) will perform the various tasks. State the estimated time to be spent on the project.

OFFERORS MUST ASSURE THAT THE PROJECT MANAGER, AND ALL OTHER PERSONNEL

PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE

THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED

THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME,

THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE

TIME COMMITMENT.

The Contracting Officer’s Representative (COR) will provide guidance on the specific work being performed, when needed, requested or as required by the Statement of Work.

The Contractor, however, shall be responsible for the management and supervision of all Contractor employees (including any subcontractor employees, if applicable) that are working under this contract.

Provide complete detailed resumes of the proposed personnel. Resumes shall include educational background and related experience. In particular, experience with clinical trials or biomedical environment shall be included. Include dates, places and names of previous employers, and any related training.

It is estimated that the following roles and responsibilities would be required to perform the contract:

a. Program Manager

In general, it is expected that the Program Manager shall possess relevant education and/or at least three years of management experience in the health care/clinical research fields. The CV of the individual must include all relevant education and any certifications earned. As the Program Manager shall be responsible for coordinating all Contractor activities pertaining to the work specified in the Statement of Work (SOW), this individual must demonstrate self-motivation, superior project and personnel management, effective communication, organization and process improvement skills in the following but not limited areas:

Amendment 0001

● Knowledge and experience in clinical trials development processes (both scientific and administrative); and knowledge and experience within the oncology community.

● Overall management capabilities, which would permit the effective implementation of all tasks on the project, including demonstrated experience in supervising all efforts of the type to be conducted under the contract, including managing teams of health care professionals at all levels.

● Knowledge and experience with business improvement practices, which includes knowledge of quality control and quality assurance methods for all contract activities.

● Experience in dealing with health care professionals at all levels, including effective use of both verbal and written communication skills and ability to provide successful presentations to those professionals, including orientation of new staff members.

● Education and knowledge of medical terminology. (MS in Scientific Field strongly preferred)

● Knowledge and experience with the development and administration of

b. Deputy Program Manager

In general, it is expected that the Deputy Program Manager shall possess relevant education and/or management experience in the health care/clinical research fields.

The CV of the individual must include all relevant education and any certifications earned. As the Deputy Program Manager shall be responsible for assisting the Program Manager--and serving in the Program Manager’s capacity during the Program Manager’s absence-- in the coordination of all Contractor activities pertaining to the work specified in the Statement of Work (SOW), this individual must demonstrate self-motivation, superior project and personnel management, effective communication, organization and process improvement skills in the following but not limited areas:

● Extensive Knowledge and experience in clinical trials development processes (both scientific and administrative aspects); and knowledge and experience within the oncology community.

● Extensive knowledge of processes and looking up information in several different databases along with email archives to track and follow up on protocol development.

● Overall management capabilities, which would permit the effective implementation of all tasks on the project, including demonstrated experience in supervising all efforts of the type to be conducted under the contract, Amendment 0001 including managing teams of health care professionals at all levels.

● Knowledge and experience with business improvement practices, which includes knowledge of quality control and quality assurance methods for all contract activities.

● Experience in dealing with health care professionals at all levels, including effective use of both verbal and written communication skills and ability to provide successful presentations to those professionals, including orientation of new staff members.

● Education and knowledge of medical terminology. (MS in Scientific Field strongly preferred)

● Knowledge and experience with the development and administration of survey tools

c. Document Specialists/Senior Document Specialists:

List the names of all Document Specialists who will be participating in the project.

Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.

In general, it is expected that the Document Specialists shall possess relevant education and/or experience in the health care/clinical research fields. All relevant education and any certifications earned shall be provided. However, resumes shall not be provided other than those who will be serving as backup Key Personnel. As the Document Specialists shall be responsible for performing the activities pertaining to the work specified in the Statement of Work (SOW), these individuals must demonstrate self-motivation, effective communication, organization and process improvement skills in the following but not limited areas:

● Knowledge and experience in clinical trials development processes

(both scientific and administrative aspects)

● Education and knowledge of medical terminology. (MS in Scientific Field strongly preferred)

● Experience in dealing with health care professionals at all levels, including effective use of both verbal and written communication skills and ability to assist in providing successful presentations to those professionals, including orientation of new staff members.

In addition, all proposed personnel shall demonstrate the following technical proficiency:

● Demonstrated experience with utilization of databases (including data

Amendment 0001 element abstraction, milestone entry, generating queries and running canned reports), document management systems, the Internet, and Microsoft Office products;

● Knowledge and experience with the development and administration of

● Proficiency with Microsoft Office and SharePoint as well as Adobe Acrobat.

The offeror shall maintain a backup plan personnel system for key personnel and key positions. Provide a detailed description of how the contract performance will be maintained during fluctuations in the personnel needs as a result of high or low levels of work, etc. Also explain in detail the plan for maintaining performance during periods of extended absences by personnel (defined as greater than 10 consecutive working days). For personnel proposed as “backup” personnel to key positions, curriculum vitae or resumes must be provided.

Backups named must be thoroughly familiar with the position that they are supporting. The offeror shall demonstrate the availability of personnel proposed on the project.

Page 91 SECTION M 4. TECHNICAL EVALUATION FACTORS A. Personnel and Experience is deleted and replaced with the following:

Deleted:

Demonstrated understanding of the staffing and experience required to perform the tasks identified in the Statement of Work.

1. Appropriateness and Adequacy of the qualifications of the Project Management [Program Manager, Deputy Program Manager and Senior Document Specialist(s)] through demonstrated knowledge and experience of:

a. Clinical trials development processes (both scientific and administrative aspects) within the oncology community;

b. Managing teams of health care professionals at all levels, especially within the oncology community;

c. Business process improvement practices;

d. Utilization of databases for data element abstraction, milestone entry, generating queries and running canned reports; document management systems, the Internet, and Microsoft Office products;

e. Medical terminology and the development and administration of survey tools.

2. Appropriateness and Adequacy of the qualifications of Other Professional Support (Document Specialists) through demonstrated knowledge and experience of:

a. Clinical trials development processes (both scientific and administrative aspects);

b. Medical terminology;

Amendment 0001

c. Utilization of Databases for data element abstraction, milestone entry, generating queries and running canned reports; and

d. Communication, both verbally and in writing, with health care professionals at all levels.

3. Appropriateness and Adequacy of the combined range of experience of the proposed team members with the tasks required by the Statement of Work

Replaced with:

Demonstrated understanding of the staffing and experience required to perform the tasks identified in the Statement of Work.

1. Appropriateness and Adequacy of the qualifications of the Project Management [Program Manager and Deputy Program Manager] through demonstrated knowledge and experience of:

a. Clinical trials development processes (both scientific and administrative aspects) within the oncology community;

b. Managing teams of health care professionals at all levels, especially within the oncology community;

c. Business process improvement practices;

d. Utilization of databases for data element abstraction, milestone entry, generating queries and running canned reports; document management systems, the Internet, and Microsoft Office products;

e. Medical terminology and the development and administration of survey tools.

2. Appropriateness and Adequacy of the qualifications of Other Professional Support [Senior Document Specialist(s)/Document Specialist(s)] through demonstrated knowledge and experience of:

a. Clinical trials development processes (both scientific and administrative aspects);

b. Medical terminology;

c. Utilization of Databases for data element abstraction, milestone entry, generating queries and running canned reports; and

d. Communication, both verbally and in writing, with health care professionals at all levels.

3. Appropriateness and Adequacy of the combined range of experience of the proposed team members with the tasks required by the Statement of Work

Appendix I (Onsite Contractor Version) Code of Conduct Expectation To safely and successfully open the NIH, we must consciously cultivate a culture of safety and responsibility in all areas. In occupational health and safety guidance, there are several key elements to building a workplace culture of safety that we incorporate in this effort: communication, employee involvement, training, leadership by example and a well-defined reporting process. This document is meant to inform the expected Code of Conduct of all NIH staff to uphold the safety work practices and policies set into place to minimize exposure of staff as they are returning to physical workspaces.

Please sign below to acknowledge that you understand NIH’s expectations in complying to this Code of Conduct:

Individual (Onsite Contractor Personnel) Responsibilities To be permitted to enter physical workspaces, individuals must:

1. Complete COVID-19 worksite specific training relevant for one’s access as required by NIH Policy. Additionally, a DOHS video will be required for all NIH staff and tracked in the Learning Management System (LMS). (See attached tip sheet)

2. Comply with occupational health policies regarding reporting and contact-tracing of individuals with any COVID-19 symptoms or test-confirmed diagnosis. These include reporting any COVID-19-like symptom to OMS, staying home if/ when sick, quarantining or self-isolating as instructed by physicians or after traveling as required by local government.

3. Comply with the safety measures defined in the approved plan specific to their research or administrative group and with NIH policies on face coverings and distancing protocols. This means wearing appropriate facial coverings, cleaning and disinfecting work site as required and complying with other risk mitigation measures outlined by NIH and DOHS.

4. Agree that each and every access of buildings represents an attestation – that one declares her/ himself symptom-free, consent to the opt-in health policy, and agree to comply with all safety measures on and between campuses, both inside and outside buildings.

NIH Work Unit Responsibilities

1. Develop staffing and spacing usage plans.

2. Review plans with workers and revise as necessary based on feedback.

3. Submit return to work plans for review by ICO leadership.

4. Provide site specific training to all workers prior to reentry on COVID-19 related enhanced practices.

1. Ensure open reporting of safety and health related concerns.

2. Ensure staff understand reporting of COVID-like symptoms and do not report to the workplace with symptoms, or if they have had a high-risk exposure to someone with COVID disease.

3. Ensure staff are complying with the return to work plans, policies and reporting requirements and enforcing these requirements when necessary.

Date

Contractor Employee Name

Supervisor Name (Company)

Contractor Employee Signature

Supervisor Signature (Company) Date

Contractor (Company) Responsibilities

Attachment 21 - Code of Conduct

NIH Coronavirus Safety Guidance Video Technical Tips

DEADLINE: Before you Return to the Workplace

INTRODUCTION

This course is intended to be viewed as a supplement to the NIH Safety Guidance. Please also read that document and discuss with your supervisor. The information below provides tips to help alleviate common HHS Learning Portal (LMS) technical issues.

LAUNCHING THE ONLINE COURSES

1. Select the following link: NIH Coronavirus Safety Guidance Video

2. Choose “Launch and Register”

3. NEW IMPORTANT INSTRUCTION: CLOSE the LMS window after launch in order to successfully view the video

WATCH THE VIDEO AGAIN?

1. Select the following link: NIH Coronavirus Safety Guidance Video

2. Choose “Launch and Register”

3. On the “Please read… screen, select “Continue Registration” in the lower right

4. The video should re-launch. Please close the LMS window again.

TECHNICAL TIPS

• Windows users access via Internet Explorer (IE) and Google Chrome

• Mac users access via Google Chrome or Safari

• Unfortunately, the LMS is not mobile-ready. This means that if someone completes the training on their devices, it will NOT mark complete. The trainings will need to be manually marked complete.

Close the LMS window once video appears

Attachment 21 - Code of Conduct https://orsweb.od.nih.gov/Documents/Return-to-Work-Guidance.pdf https://lms.learning.hhs.gov/Saba/Web/Main/goto/GuestOfferingDetails?offeringId=dowbt000000000042232&isFromDeeplink=true https://lms.learning.hhs.gov/Saba/Web/Main/goto/GuestOfferingDetails?offeringId=dowbt000000000042232&isFromDeeplink=true

COMPLETING THE COURSE

• You must complete each course in its entirety to receive credit. Once completed, the LMS will track your completion for each course. If your completion does not automatically appear, give the LMS time to update. It can take up to an hour.

• In order to view your Completed Learning (transcript), please use the following reference guide:

View Your Completed Learning.

ADDITIONAL ASSISTANCE

• For LMS technical questions and technical support, submit an HR Systems Support Ticket Form.

• For course content questions, please refer to the NIH Safety Guidance, contact DOHS_COVID19@mail.nih.gov, or contact your supervisor.

• For non-LMS related technical issues with your equipment, please contact the NIH IT Service Desk via http://itservicedesk.nih.gov for assistance.

Attachment 21 - Code of Conduct https://hr.nih.gov/sites/default/files/public/documents/hr-systems/lms/pdf/ts04-l-viewing-your-transcript.pdf https://hr.od.nih.gov/hrsystems/benefits/lms/documents/TS04-L_Viewing_Your_Transcript.pdf https://nihohrweb.nih.gov:1010/WiTS_IntraHR/WiTSHome.aspx https://nihohrweb.nih.gov:1010/WiTS_IntraHR/WiTSHome.aspx https://orsweb.od.nih.gov/Documents/Return-to-Work-Guidance.pdf mailto:DOHS_COVID19@mail.nih.gov http://itservicedesk.nih.gov/

Return to Work Guidance July 2020 version

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Attachment 22 Contractor Return to Physical Workspaces – Code of Conduct

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Contents Executive Summary

Return to Work Expectations

Symptom Monitoring and Reporting Requirements

Staffing Plans

Alternative Work Scenarios

Guidance on Personal Safety

Facial Coverings

Use, Care and Changing of Face Coverings

Physical Distancing

Hand Hygiene

Gloves

Coughing/Sneezing Hygiene

Guidance on Cleaning and Disinfection

Guidance for Personnel in Specific NIH Workspaces

Office Environments

Common Areas

Restrooms

Elevators

Stairwells

Hallways and Corridors

Break Areas

Meeting Spaces and Conference Rooms

Food Services and Cafeterias

Laboratories

Laboratory Scheduling Precautions

Laboratory Cleaning and Disinfection Precautions

Personal Protective Equipment (PPE) Precautions

NIH Centralized Services

Mechanical Spaces

Staff Wellness

Appendix I Code of Conduct

Appendix II Map of Disposal Containers for Face Coverings

Appendix III Disinfectant Labels

Appendix IV Risk Matrix for Workplace Operations

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Executive Summary The NIH Division of Occupational Health and Safety (DOHS) has compiled this guidance to provide NIH staff, including employees, contractors, and trainees, with information on recommended practices and available resources on a Code of Conduct based on this guidance as we return to physical workspaces. The pandemic brings many new uncertainties that warrant changes l operations. Implementing these changes can be a challenge. The goal of this document is to provide awareness, options and tools for new, enhanced safety practices in your workspaces. Occupational health and safety principles are grounded in risk mitigation measures including elimination, substitution, engineering controls, administrative controls, work practice controls and personal protective equipment. All of these controls are covered in this document, with suggested mechanisms for use in our laboratory, non-laboratory and common areas. Additionally, some areas will require specialized guidance. DOHS is working with partners within the Office of Research Services (ORS) and the Office of Research Facilities (ORF) to review processes for those locations. Additional practices may be performed in spaces not outlined in this document. This guidance is not meant to supersede or be in conflict with the procedures or policies of any NIH Institutes, Centers, and Offices (ICOs). A one-size-fits-all approach is not possible, but we hope this will assist all ICOs in developing their specific procedures.

Finally, in public health emergencies, it is important that all persons follow these recommendations in order to ensure the safest workplace for everyone. In most cases, these recommendations do not eliminate risk completely. They attempt to create awareness on how risks are handled and how we can behave and respond in order to protect ourselves, colleagues, patients and the general NIH community. Key points include:

Staff, visitor and patient safety are paramount Physical distancing in the workplace limits the spread of coronavirus Face coverings will be mandatory while on campus, with specific guidance based on work areas Vigilant adherence to hand hygiene and surface disinfection routines mitigates transmission risk Guidance in this document will be updated and reissued as national safety guidance changes

This document includes a Code of Conduct Acknowledgement (Appendix I) for all supervisors to discuss and sign with staff. This Code of Conduct highlights the responsibilities we have to each other, and to ourselves, to maintain the highest level of safe practices at the NIH. NIH leadership expects all staff to comply with this Code of Conduct.

DOHS has created a COVID-19 Safety Reporting Tool and a Coronavirus hotline at 301-480-8990 for reporting unsafe conditions, COVID-19 symptoms and medical follow-up.

Return to Work Expectations This document is intended to provide guidance for all NIH staff returning to the workplace in the era of COVID-19. Topic areas have been identified to educate staff on protecting themselves as well as others in work areas. Not all areas are the same: laboratories, offices, and customer support areas will need to develop specific procedures for their respective activities. The goal is to minimize the risk of transmission in the NIH community and to provide examples of how work areas might be organized to support procedures and best practices.

To safely open the NIH, we must embrace a culture of responsibility. Every NIH staff member has a critical role in ensuring the occupational health and safety of their colleagues. Principal Investigators and

- 3 -supervisors will play a key role in establishing new protocols for their staff. These staff members will then be responsible for practicing and employing new paradigms in their work. SARS-CoV-2 exposure is a hazard we all can help mitigate by adhering to personal hygiene, administrative controls, and distancing guidelines.

NIH ICOs will formulate detailed plans using this guidance as a high-level framework which should not be superseded. NIH ICOs and laboratories will need to perform internal assessments to determine which activities will be resumed and in what timeframe. This may begin in Group A and continue through Group D before an ICO is fully functioning with all staff back at their physical worksites (NIH Framework for Returning to Physical Workspaces). All NIH staff should be provided with information about their ICO-specific plans and have opportunities or platforms to discuss concerns with supervisors and/or ICO leadership. The plan should be revised as necessary, recognizing that not every concern can be immediately addressed and that some decisions may need to be modified as more information becomes available and as the pandemic evolves.

Until further notice, face coverings will be required for staff physically present on any NIH campus, when entering or exiting NIH-owned or leased facilities, or in common areas in and around NIH-occupied facilities. Face coverings are a fundamental part of preventing the spread of coronavirus. When you wear a face covering, you reduce the dispersion of airborne droplets. The health and safety of NIH employees, contractors, visitors and patients depends on everyone doing their part. Supervisors will be responsible for ensuring that staff comply with this policy.

If you see something at the NIH that you think may create a risk of coronavirus exposure, please report it to your supervisor or your ICO Health and Safety Committee. Concerns can also be reported anonymously through the COVID-19 Reporting Tool or to the Coronavirus hotline at 301-480-8990. All reported concerns will be investigated and shared with appropriate staff, including NIH and ICO senior leadership, if necessary.

Symptom Monitoring and Reporting Requirements Self-monitoring can prevent the spread of coronavirus by limiting the exposure of others to symptomatic personnel. Before you leave for work, take a moment to assess yourself and see if you have any symptoms associated with coronavirus. According to the most recent CDC Guidance these symptoms are:

Fever, chills Cough Unexplained loss of taste or smell Congestion or stuffy nose Headache

Sore throat Shortness of breath Muscle or body aches/pain Diarrhea Nausea or Vomiting

NIH staff experiencing any of these symptoms should NOT report to work. Contact Occupational Medical Service (OMS) for an evaluation by completing the screening questionnaire. Please contact your supervisor to discuss your leave or duty status.

In addition, check if your family or housemates are experiencing symptoms. If so, encourage them to stay at home and seek an evaluation from a medical provider. If you have had close contact with someone with confirmed or suspected COVID-19 in the past 14 days, please contact coronavirus hotline at 301-480- 8990 before reporting to work and complete the screening questionnaire.

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Staffing Plans The NIH Coronavirus Response Team carefully considered the NIH Framework for Returning to Physical Workspaces developed by the NIH Office of Human Resources, in close coordination with NIH ICO leadership. The Framework provides guidance to NIH ICOs based on common principles as they develop their specific workplans to bring their staff gradually and safely back to physical workspaces.

Importantly, the plan focuses on a gradual ramp up of staff only if certain criteria are met, most notably a 14-day trend in declining COVID-19-like case reports and confirmed COVID-19 positive cases in the counties where NIH has facilities. The NIH Office of the Director (OD) will continuously monitor local conditions and trends to update and revise staffing guidelines and policies. Maximum telework will continue until further notice as we assess local health and operational conditions. NIH staff should not return to their physical workspaces unless previously approved to do so.

Alternative Work Scenarios ICOs will need to evaluate the best staffing options available for the identified work function or office.

Staffing scenarios for the laboratory may differ significantly from an administrative office setting, which may, in turn, differ from a front-facing customer service operation. Alternating days or weeks, shift work, or physical separation of workstations should be considered. Understanding there will be scenarios where physical distancing cannot be achieved, DOHS (301-496-2960) is available to consult and help develop alternative safety measures to mitigate risk. In these situations, ICOs will need to assure strict adherence to face coverings, other protective measures and other administrative controls, and supervisors must minimize these situations to the best of their ability. Maximum use of telework and flexibilities is still highly encouraged, and your health and safety are our highest priority.

Guidance on Personal Safety Facial Coverings Facial coverings are required to be worn by all staff and visitors, at all times on any NIH campus or facility including in common areas and conference rooms. Appropriate use of facial coverings is critical in minimizing transmission as you can spread COVID-19 to others even if you do not feel sick or have any of the cited symptoms. Facial coverings with exhalation ports are NOT recommended since they will not provide source control, as air will leave from these valves without adequate filtration. Exhalation ports are the small, plastic-like items on the front of the facial covering that allow air to move out of the mask. The mask or cloth face covering is not a substitute for physical/social distancing and should be used to supplement other controls recommended in this document. Staff should evaluate the need for a separate mask to be used during their commute to their worksite and home. In addition, cloth face coverings should only be used in a BSL2 environment if the individual is not performing research.

It is strongly recommended that cloth face coverings be changed and laundered daily. If reuse of a facial covering is necessary, face coverings and/or masks should be stored in paper bags or in some other protective device to reduce the…