RFP 75N91020R00037 Amendment 1.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: 1) Provide responses to questions received; 2) Update SECTION J to add Attachment 20, 21, and 22; 3) Revise the Additional Technical Proposal Instructions and replace paragraph 15 with Additional Business Proposal Instructions in the RFP

Attachments 20, 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

To All Potential Offerors 75N91020R00037

1 12

09/09/2020

08/07/2020

RFP Number: 75N91020R00037 Amendment 0001

-Page 2 of 12

RFP 75N91020R00037

Amendment 1

I. Questions and Answers

a. Technical Questions

1. How many trials/projects/studies are anticipated annually? How many are supported concurrently?

NCI Response: Please see the Additional Business Proposal Instructions (IV.L.2.c.15) for details about these anticipated numbers.

2. Aside from the laptops, systems, and databases identified in the solicitation, what additional GFE does the Government intend to provide? Further, what equipment or systems is the contractor expected to provide and/or purchase?

NCI Response: Please see the Additional Business Proposal Instructions (IV.L.2.c.15) for details about these Government Furnished Property and Government Furnished IT systems and databases. If additional equipment or systems are needed based on the Offeror’s approach, the Offeror is expected to furnish these items.

3. What are NCI-available technologies (e.g., software, applications, printers)?

NCI Response: Please see the Additional Business Proposal Instructions (IV.L.2.c.15) for details about the Government Furnished Property and Government Furnished IT systems

4. What does the current staffing structure look like?

NCI Response: Please refer to the Additional Business Proposal Instructions (IV.L.2.c.15) and the Additional Technical Proposal Instructions (IV.L.2.b.5) for information about the personnel and level of effort assumptions.

5. How many current FTE are there, in total?

NCI Response: Please refer to the Additional Business Proposal Instructions (IV.L.2.c.15) and the Additional Technical Proposal Instructions (IV.L.2.b.5) for information about the personnel and level of effort assumptions.

6. What are the specific labor categories supporting the incumbent contract?

NCI Response: Please refer to the Additional Business Proposal Instructions (IV.L.2.c.15) and the Additional Technical Proposal Instructions (IV.L.2.b.5) for information about the personnel and level of effort assumptions.

7. Is the current incumbent performing this work at a Government site or at the contractor's facility?

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NCI Response: It is expected that, in normal conditions, work will be performed at both a Government site and at the contractor's facility. Please refer to the Additional Business Proposal Instructions (IV.L.2.c.15) for additional assumptions.

8. Please clarify which positions are to be considered Key Personnel.

NCI Response: Please refer to the Additional Technical Proposal Instructions: "The Government intends that based on the offeror's proposed approach other staff, in addition to the Contract Lead(s), may be considered to be key persons. This will be determined during negotiations." Please propose anyone that you deem to be essential as Key Personnel.

9. Please clarify – will the Government provide the offerors an enterprise map of all the websites to be maintained by the Contractor under this SOW? Without incumbent knowledge of the current enterprise, bidders would not have enough information to reasonably respond to this requirement.

NCI Response: Please note that the CTEP Enterprise System is supported by other Contractors and is not within the scope of this contract. A visual of the CTEP Enterprise System has been uploaded as a reference for the bidders. Please note that this is the CTEP Enterprise System as it currently stands and could be subject to change.

10. Is this website hosted by the Government? Will the awarded contractor be required to host (either with an on-premises server or a cloud server) the website?

NCI Response: This website is not hosted by the Government. The contractor will be required to host this website.

11. What databases will be transferred to a new awardee?

NCI Response: Current ad hoc databases used to track accrual, projects, and steering committee members will be transferred.

12. What is the size of the current databases?

NCI Response: Current databases vary in size, but most are relatively small.

13. What are the database applications used?

NCI Response: Current databases are primarily created in Microsoft Excel; some are in Access.

14. Where are the databases located--on or off-premises or a hybrid?

NCI Response: Current databases are located on either the CTEP Shared Drive or the contractor's systems.

15. Does the incumbent team use any incumbent-proprietary systems to support CTIMS that would need to be either transitioned to the new awardee or replaced? Please describe the systems and their core functionality.

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NCI Response: No incumbent-proprietary systems are being used.

16. Will the new contractor be taking over and enhancing existing systems or does NCI envision the implementation of new systems?

NCI Response: The scope of this contract includes accessing and potentially entering data in these systems, as well as potentially providing user feedback to the contractors that support these systems.

The scope of this contract does not include taking over, enhancing, or implementing new systems.

17. For the purpose of comparing like with like in terms of Business Proposals, can the Government provide the expected (or a nominal) number of resources for each role or labor category?

NCI Response: Please refer to the Additional Business Proposal Instructions (IV.L.2.c.15) and the Additional Technical Proposal Instructions (IV.L.2.b.5) for information about the resources.

18. Please clarify NCI’s expectations with regards to contractor telework during and after the COVID-19 pandemic.

NCI Response: During the COVID-19 pandemic, NCI is allowing contractors maximum flexibility to perform telework. Under normal conditions, contractors should be prepared to work remotely in the event the government is directed to work from home. Otherwise, please refer to the Additional Business Proposal Instructions (IV.L.2.c.15) regarding assumptions for personnel available to work on-site.

19. Beyond IT systems, is NCI seeking the development and/or implementation of new clinical trial systems?

NCI Response: No. Through this contract, NCI is seeking information and project management support for existing and new clinical trial systems. The contractor will be supporting, but not be developing or implementing, existing and new clinical trial systems.

20. In assigning and tracking tasks and approvals, does DCTD currently have a system that they would expect us to use, or will the contractor provide a solution? Given this requirement, how will the contractor receive tasks and subtasks, and what will the expected "approval" process be?

NCI Response Per the Statement of Work, the Contractor shall implement a project management and task approval system to track contract tasks, subtasks and overall performance of the contract. Potential tasks and subtasks will be identified by NCI professional staff, discussed with the COR, and reviewed by the COR based on the scope of the potential work and the contract capacity. The contractor will then be notified of approved tasks and subtasks.

21. Does the design of data collection instruments refer solely to the design of instruments or also the configuration and/or build of tools?

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NCI Response: This refers to the design of instrument questions as well as the collection tool, such as a commercial online survey tool.

22. To provide the correct staffing and expertise in our bid, could the Government provide documentation describing the CTEP Enterprise system?

NCI Response: A visual of the CTEP Enterprise System has been uploaded as a reference for Offerors.

23. Is the CTEP shared drive on an NIH-controlled network or a contractor-provided shared drive?

NCI Response: This is a shared drive on an NIH-controlled network.

24. Are the local databases, per item 15 on page 7 of the Statement of Work, contractor-provided or Government-provided? If they are Government-provided, what is the database application used?

NCI Response: Local databases may be contractor-provided or Government-provided depending on whether NCI staff require access to the documents on a per-project basis. Government-provided solutions may include folders within the CTEP shared drive, a DCTD-provided SharePoint site, or NIH Box.

25. Would the additional local databases, per item 3 on page 7 of the Statement of Work, be hosted on NIH networks or contractor provided networks?

NCI Response: Additional local databases may be hosted on the CTEP shared drive and/or NIH networks if NCI staff require access or on contractor provided networks, as needed.

26. Is the database, per item B.1. on page 12 of the Statement of Work (maintain CTAC membership), on an NIH network, or a contractor network? If they are Government provided, what is the database application used? This information will allow bidders to propose staff with the correct skills and knowledge.

NCI Response: This database is on a contractor network.

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b. Administrative/Business Questions:

27. For the business proposal to be compliant, must the team members' letters of intent meet the subcontracting goals as defined by this section of the solicitation?

No, letters of intent are not required. The HHS subcontracting template – attachment 10 must be completed.

28. By what process would the Government prefer for the prime contractor's subcontractor teammates to provide sealed bids?

NCI Response: There is currently no utility built as part of the eCPS to hide/separate subcontractor information from the prime. Please have your teaming partners submit this directly to the CS/CO with reference to the RFP number 75N91020R00037 and the RFP name.

Please note that this procurement is utilizing FAR Part 15 and the Government is requesting competitive proposals and not sealed bids per FAR part 14. Additionally, this will be submitted in eCPS, not beta.SAM.gov. Please correct.

29. How many annual hours are determined to be an FTE?

NCI Response: Total hours of 1880 or 2080 hours are generally accepted FTE basis used by companies.

The Offeror should clarify in their proposal the number of hours for an FTE within their organization.

30. Are there expectations (or opportunities) to retain current staff?

NCI Response: There is no requirement to retain the incumbent staff.

31. Does the Government require bidders to provide 6 projects, e.g., 3 contracts "completed (no longer active)" and 3 contracts "currently being performed?" For the 3 completed, should these be similar to the work in this RFP?

NCI Response: Yes, 3 contracts completed during the past 3 years, and the last 3 current contracts.

32. Please confirm the specific format required for the Past Performance references--should this be delivered as a formal reference or as a list of contracts?

NCI Response: Please provide a list of contracts with the information requested on page 67 of the RFP.

33. Please confirm the number of total Past Performance references required by the Government. Is the Government anticipating the receipt of six separate references (lists), 3 for similar contract work COMPLETED during the past three years and 3 for similar work

IN PROGRESS?

NCI Response: 6 contracts; 3 past contracts; 3 current

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34. Is the Information Security narrative excluded from the 150-page limit?

NCI Response: included, and if additional technical documentation is needed, please include it in an appendix.

35. Does this also include graphics and figure legends?

NCI Response: Yes

36. Are the appendices considered included in the 150-page limit?

NCI Response: No, however the Government encourages the offerors to be complete but succinct in the presentation and to limit the total number of pages for the entire proposal to 150 pages.

37. Is the 150-page limit inclusive of both the Technical and Business Proposals?

NCI Response: Yes

38. Is the enterprise map excluded from the 150-page limit?

NCI Response: No enterprise map is expected from the Offeror and this has been corrected in the RFP Amendment.

39. Does the VPAT need to be submitted with the bid or is this a post-award requirement?

NCI Response: Yes, the VPAT needs to be submitted as part of the proposal.

40. If the VPAT is a requirement for submission, in what volume should it be included and is it within or outside of page count?

NCI Response: Not counted in page limit. Please see the RFP amendment for Technical Proposal Instructions.

41. Please clarify that you intend the cost proposals to estimate for 36 trips per year.

NCI Response: This is provided on page 105 of the RFP, it is for the Offeror to derive an estimate based off the assumptions NCI provided in the RFP.

42. The Intent to Bid worksheet, Attachment 2, currently has a suspense date of 21 September, the proposal due date. What is the correct deadline for the Intent to Bid attachment?

NCI Response: The intent shall be submitted on or before the due date of September 21.

43. This form only has fields for 4 option periods. Given that this contract has 7 periods, are we to use the template provided or providing a subcontracting plan using the template as an example?

NCI Response: The provided template is an example. Please customize the template as needed.

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II. Revisions to Sections of the RFP

ARTICLE H.17 on page 38 is hereby added as follows:

Added

ARTICLE H.17. For all onsite contracts as contractors return to physical workspace or utilize NIH COVID-19 asymptomatic testing program

Coronavirus disease 2019 (COVID-19) – NIH policy may allow for voluntary or mandatory COVID-19 testing for contractor personnel. Contractor personnel who test positive for COVID- 19 or who do not wish to submit to mandatory COVID-19 testing will not have access to or be permitted to work in NIH [ICs] until they have satisfied the access requirements in the NIH policy. A contractor personnel’s decision to opt out of mandatory COVID-19 testing will not automatically constitute grounds for any performance delays or establish any government liability for additional costs. The Contracting Officer may determine that an excusable delay is appropriate under applicable FAR clauses (e.g., 52.242-14 (Suspension of Work), 52.242-15 (Stop-work Order), 52.249-14 (Excusable Delays), and 52.212-4(f) (Excusable Delays)) in cases where a positive test result is recorded and contract personnel must be quarantined due to an exposure to COVID-19. However, cases where a positive test result is recorded will not establish any government liability for additional costs.

Contractors shall ensure compliance with all Federal, HHS, NIH and individual IC COVID-19 policies related to health and safety, including relevant Codes of Conduct and reporting requirements applicable to contractor personnel. The Contractor shall discuss the Code of Conduct with contractor personnel, retain signed Codes of Conduct, and confirm their signature with the Contracting Officer. Reporting requirements include: 1) Ensure open reporting of safety and health related concerns; 2) Ensure staff understand reporting of COVID-like symptoms to contract supervisors, if they have had a high-risk exposure to someone with COVID disease, or if they have tested positive for COVID-19, and that staff do not report to the workplace with symptoms or if they have tested positive for COVID-19; 3) Ensure staff are complying with the return to work plans, policies and reporting requirements and enforcing these requirements when necessary; and 4) Ensure contract supervisors inform the Contracting Officer of personnel with COVID-19 symptoms.

The Return-to-Work Guidance and Code of Conduct for On-Site Contractors (attachment 21 and attachment 22) are incorporated into this RFP. Contractors shall ensure contract personnel are aware they are to contact their company/supervisor for guidance.

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Testing conducted by the NIH Occupational Medical Service (OMS) falls within Privacy Act System of Records Notice (SORN), 09-25-0105, Administration: Health Records of Employees, Visiting Scientists and Others Who Receive Medical Care through Employees Health Unit, HHS/NIH/ORS.

Information regarding the Countermeasures Injury Compensation Program under the Health Resources and Services Administration is available at 1–855–266–2427 or http://www.hrsa.gov/cicp/.

Page 55 – SECTION J - LIST OF ATTACHMENTS:The following attachments are added as follows:

Added:

Attachment 20: CTEP Enterprise System Diagram for CTIMS SOW.

Attachment 21: Code of Conduct

Attachment 22: Return to Work Guidance

Page 87 – Additional Technical Proposal Instructions: paragraph entitled “TOTAL PAGE COUNT DOES NOT INCLUDE” is hereby deleted and replaced with the following

Deleted:

TOTAL PAGE COUNT DOES NOT INCLUDE (some of which may be added as appendices): Table of Contents; Section Dividers that do not contain information other than title of Section; Resumes/CVs of personnel (with highlights of any items that are directly related to the project); letters of commitment by proposed consultants and subcontractors.

Replaced with:

TOTAL PAGE COUNT DOES NOT INCLUDE (some of which may be added as appendices): Table of Contents; Section Dividers that do not contain information other than title of Section; VPAT, Resumes/CVs, of personnel (with highlights of any items that are directly related to the project);

letters of commitment by proposed consultants and subcontractors.

Page 89 - Technical Approach and Understanding of the Project The third paragraph is deleted and replaced with the following:

Deleted:

The Offeror shall demonstrate in its proposal its ability to develop and maintain websites and/or databases for data sharing activities. The Gynecologic Cancer Intergroup Committee (GCIC)website will need to be maintained by the Awardee ( https://gcigtrials.org/). The Scientific Steering Committee file sharing websites for the committees will also need to be maintained by the Awardee. The Awardee shall demonstrate capability of using the following Government Furnished Information Technology Systems and Databases and will provide an enterprise map as a separate attachment to this RFP.

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Replaced with:

The Offeror shall demonstrate in its proposal its ability to develop and maintain websites and/or databases for data sharing activities. The Gynecologic Cancer Intergroup Committee (GCIC)website will need to be maintained by the Awardee ( https://gcigtrials.org/). The Scientific Steering Committee file sharing websites for the committees will also need to be maintained by the Awardee. The Awardee shall demonstrate capability of using the following Government Furnished Information Technology Systems and Databases.

Page 103: Paragraph 15 is deleted and replaced with adding the following title:

Deleted:

15. Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the technical evaluation criteria, and, the RFP as a whole, in the development of your proposal. The information requested here should be used as further guidance for the development of your Business Proposal.

Replaced with:

15. Additional Business Proposal Instructions:

Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the technical evaluation criteria, and, the RFP as a whole, in the development of your proposal. The information requested here should be used as further guidance for the development of your Business Proposal.

Page 106 – 7. Estimated Level of Effort (LOE) for Base and Term Options is deleted and replaced with the following:

Deleted:

7. Estimated Level of Effort (LOE) for Base and Term Options

The Government provides the following estimated LOE for the base of 12 months and six 12 month option periods and seven options for increased quantities, one in each period. The Government estimates that the Contractor will need to provide not less than 85% nor more than 110% of the total direct labor hours noted for each period. Negotiated fixed fee will be reduced in the event the actual hours worked are less than 85% of the negotiated hours included in the award. No additional fee will be paid for hours provided in excess of 100% up to 110% of the hours negotiated and included in the award. One Phase out option is also anticipated. For the Option for Phase Out, the Government estimates the level of effort to be the same level effort as would be needed for any term option, except for a period of performance of 45 days. Please see Section L Paragraph D. Level of Effort.

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The Cost section of the Business Proposal shall be presented in a format similar to the following:

https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours

Replaced with:

7. Estimated Level of Effort (LOE) for Base and Term Options

The Government provides the following estimated LOE for the base of 12 months and six 12-month option periods and seven options for increased quantities, one in each period. The Government estimates that the Contractor will need to provide not less than 85% nor more than 110% of the total direct labor hours noted for each period. Negotiated fixed fee will be reduced in the event the actual hours worked are less than 85% of the negotiated hours included in the award. No additional fee will be paid for hours provided in excess of 100% up to 110% of the hours negotiated and included in the award. One Phase out option is also anticipated. For the Option for Phase Out, the Government estimates the level of effort to be the same level effort as would be needed for any term option, except for a period of performance of 45 days. Please see Section L Paragraph D. Level of Effort.

Each Base and Term Options Yearly Labor

Hours Professional 6,580

Other Professional 46,060 Support 5,640

Total 58,280

Options for Increased Capacity:

Please include increased capacity option costs for each year as part of the proposed budget.

Each Option for Increased Capacity Yearly Labor

Hours Professional 3,760

Other Professional 20,680 Support 7,520

Total 31,960

The Cost section of the Business Proposal shall be presented in a format similar to the following:

https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours

-Page 12 of 12

Please update Section 3 on page 107

Page 107 SECTION 3 Representation Regarding Certain Telecommunications and Video Surveillance:

Paragraph titled Services or Equipment and Covered Telecommunications Equipment or Services- Representation. is deleted and replaced with the following:

Deleted

Services or Equipment and Covered Telecommunications Equipment or Services-Representation.

Please copy and paste FAR 52.204-24 "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (August 2019) in its entirety or FAR 52.204-26 "Covered Telecommunications Equipment or Services-Representation." and complete paragraph c of either one indicating whether the Offeror will or will not provide covered telecommunications equipment or services to the Government and have an authorized signatory sign this representation.

Replaced with

Services or Equipment and Covered Telecommunications Equipment or Services-Representation.

Please copy and paste FAR 52.204-24 "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (August 2020) in its entirety or FAR 52.204-26 "Covered Telecommunications Equipment or Services-Representation." and complete paragraph c for both representations indicating whether the Offeror will or will not (52.204-24 only) and does or does not provide covered telecommunications equipment or services to the Government and have an authorized signatory sign this representation.

Attachment 20

- Page 1

CTEP Enterprise System Diagram for CTIMS SOW

CTEP Enterprise System includes interconnected data systems that support NCI clinical trials. The circles on the components, such as within the Clinical Data Capture and Reporting section, “Patient Enrollment Assignment” identify areas the Contractor will need to learn how to use and generate reports. CTEP has available training on their use.

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

- 1 -

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 potential for damage or contamination that could occur if the facial covering was placed on a desk or in a backpack, pocket or purse alone. Paper bags are recommended because the facial covering may be damp from breath condensation, and the paper allows the facial covering to dry out. Additionally, data indicate the virus is viable on paper for a shorter duration than plastic. A plastic bag would trap this condensation inside and not allow the facial covering to dry out.

Cloth face coverings should be cleaned using a mild detergent (e.g., Dawn®, Palmolive®, etc.) and warm water. They can be cleaned in a washing machine, a bowl or a sink. It is recommended to dry masks using

- 5 -a dryer on hot setting if available or hang dry. The use of a washing machine and dryer may damage some face coverings (e.g. elastic straps) and they should be carefully inspected each time they are used. Cloth face coverings must be immediately removed from use if visibly dirty or damaged.

The Clinical Center has issued its own facial covering policy. Persons entering the building will be issued a disposable surgical mask. Cloth face coverings must be replaced by the surgical mask whenever inside the Clinical Center. Any type of disposable mask worn at the time of entry on an NIH campus or in an NIH facility should be discarded into a trash can or in Medical Pathological Waste (MPW) containers that are commonly found in laboratories and clinical areas. For convenience, white step cans have been placed at the entries/exits of buildings, at common points of departure from NIH campuses, leased facilities and in the Clinical Center. A map of disposal locations is included as Appendix II of this document. The NIH Division of Environmental Protection (DEP) is the point of contact for disposal and questions regarding additional disposal container requests at 301-496-6349.

See details regarding face covering and mask use and care below.

Type and Intended Use of Face Coverings/Masks

T yp e

Cloth Face Covering Disposable Mask Medical-Grade Surgical Mask

N95 Respirator

D es cr ip ti on

Home-made or commercially manufactured face coverings that are washable and help contain emissions*

Commercially manufactured masks that help contain emissions

FDA-approved masks to protect the wearer from large droplets and splashes; helps contain emissions

Provides effective respiratory protection from airborne particles and aerosols; helps respiratory emissions

In te n de d Recommended for common areas and non-healthcare settings. Covering should be replaced or laundered daily. They are not required when working alone in a personal office.

These respirators and masks are reserved for healthcare providers and individuals with patient contact. Use in other areas should be determined by a risk assessment conducted by

DOHS.

* Face coverings and N95s with exhalation ports may not prevent droplet dispersion. Consult with DOHS if you have questions about your face covering or N95.

Use, Care and Changing of Face Coverings Remember, facial coverings need to be worn over your nose and mouth.

If changing from a cloth face covering to a lab mask, do so in a private setting before you enter the lab so as not to expose others.

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Wash your hands with soap or use hand sanitizer before putting the mask on, before adjusting and after removing.

Make sure your mouth and nose are fully covered, pull the mask down over your chin and pinch the bridge of the nose. Assure there are no gaps in the mask and that it fits against the side of your face.

Remove your mask using the ear loops/ties and avoid touching your eyes, nose and mouth.

Place your dirty mask in a paper bag for storage and wash your hands immediately after removing.

Use designated locations to take a break for a drink or to eat, ensuring adequate distance from others. After finishing your food or drink, immediately put your face covering back on.

Remember, never eat or drink in a laboratory. Staff can take advantage of outdoor areas on campus to eat or take breaks, weather permitting.

Physical Distancing In accordance with CDC guidance, staff should always maintain at least 6 feet from other individuals.

Avoid unnecessary person-to-person close contact, such as handshakes. In-person meetings should be avoided as much as possible. To achieve this, NIH is recommending that laboratory areas not have more than one person per 200-250 net square foot of space, dependent on the space configuration. Office spaces of 125 square feet should only have one person at a time. These recommendations will be updated as more groups return to the physical workspace, and as therapeutics and vaccines become available. Please ensure space density decisions are coordinated with NIH leadership. The U.S. Fire Administration has a useful reference to assist ICOs with determining the appropriate distances and physical separation of staff as they return to work. Additional information on physical distancing can be reviewed at the US Fire Administration website.

Hand Hygiene Wash your hands often with soap and water for at least 20 seconds, especially after you have been in a public place, after blowing your nose, coughing, sneezing, or touching your face.