Amendment 1 to Attachment 3 - Domain 3 Sample RFTOP.pdf

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

DOMAIN 3- Sample RFTOP

RFTOP Title: Promoting Infection Prevention in Dialysis Facilities Through Patient Education

Multiple task orders may be awarded subject to availability of funds and contractors should prepare technical proposals that are priced in the range$375,000.00 - $500,000 in order to be considered for award.

PROPOSED PERIOD OF PERFORMANCE: Work shall begin from date of award of the task order and shall continue for a period of 12 months. This project is a non-severable and will be funded fully at the time of award.

Multiple task orders may be awarded under this RFTOP.

PROPOSAL PREPARATION AND SUBMISSION

1. General Instructions: Offeror(s) shall submit proposals consisting of the following volumes:

Technical Proposal – Volume I Business Proposal – Volume II

a. Technical Proposal-Volume I

Technical Proposal Preparation Instructions – Page limit is (10) single-spaced pages of text for the technical proposal; (the page limit does not include appendices or resumes). Each volume in the proposal shall include a copy of the cover letter (letter of transmittal), title page and table of contents. The table of contents shall list sections, subsections and page numbers.

The technical proposal should be in as much detail as you consider necessary to reflect a clear understanding of the nature of the work being undertaken.

The technical proposal must NOT contain reference to cost; however, resource information, such as data concerning labor hours and categories, material, subcontracts, etc., must be contained in the technical proposal so that your understanding of the statement of work can be evaluated.

b. Business Proposal-Volume II

Pricing Narrative: The Offeror shall provide an explanation and/or detailed information on how the fully loaded labor rates were derived. The business proposal shall be an Excel spreadsheet, with an itemized price breakout per task for each period (e.g. Base Year, Option Years), including itemized prices for any subcontracted work. Proposed labor hours, labor costs, travel and other direct costs for this task order request shall be organized around the tasks and related deliverables described herein.

Pricing Worksheet: Utilizing the format in Attachment 11 of RFP, provide all applicable labor categories, descriptions, and rates, travel for the Prime Contractor/Subcontractor for each period (e.g. Base Year, Option Years). Please return Section B (CLIN and payment milestone) with Business Proposal.

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

SECTION B SUPPLIES OR SERVICES AND PRICES/COSTS

BASE PERIOD

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT

PRICE

EXTENDED

PRICES

0001 Safety and Healthcare Epidemiology Prevention Research Development (SHEPheRD) Program 2021 Domain 3 Promoting Infection Prevention in Dialysis Facilities Through Patient Education

POP: 12 months from award This is a Firm-Fixed Price and Non-Severable Line Item

1 Job $________ $ ___________

**The offeror requires to identify the zip code of the work site so the appropriate wage determination can be identified and included with an awarded task order.

B.1 PAYMENT TERMS

Payment will be made subject to receipt of deliverables in accordance with the payment schedule established herein and in accordance with FAR 52.232-25. Prompt Payment, which states that the due date for making invoice payments shall be the 30th day after the designated billing office (see block 21 of the order) has received a proper invoice from the vendor or the 30th day after Government acceptance of the services provided by the vendor, whichever is later.

B.2 Schedule of Milestones for Performance-Based Payments In accordance with FAR 52.232-32, PERFORMANCE BASED PAYMENTS (April 2012), upon successful completion of an event, the contractor may request performance based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the Contracting Officer’s Representative (COR) that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone.

Milestone payments are subject to the terms of FAR 52.232-32 incorporated in this contract.

The COR receiving and acceptance of monthly performance based payments is based on verification that work on the contract was satisfactorily performed during the month and that, at a minimum, the following activities were satisfactorily performed.

Milestone Payment Schedule

CONTRACTOR PROPOSED

MILESTONE EVENT PAYMENT %* DOLLAR AMOUNT

TOTAL 100 % $

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

*Milestone event payments may be allocated on a periodic basis as long as a completed event is associated with that payment.

SAMPLE PAYMENT SCHEDULE for this task order

Base Period Deliverable Due Date Payment Once Approved by COR

Facility/site/home(s) assessment document Due 3 weeks after conclusion of last study visit at that site

5% of award per report (20% total)

Assessment document – combination of all site visit findings and recommendations to CDC

Final recommendations document by POP end

5% of award

Minutes from workgroup/focus groups Within 2 weeks following meeting date and before end of POP.

2.5% of award each (10% total)

20-30 minute educational webinars for the kidney community.

Draft due to CDC 30 days before educational delivery. Final delivered content due to CDC within 60 days post-presentation and before end of POP.

10% of award each final delivered item (20% total)

Educational dialysis patient infection prevention and safety case-based learning modules.

One month prior to the end of the Period of

Performance. Final will be accessed by CDC through vendor website and should be delivered to CDC directly on live date in PowerPoint or other agreed format.

Final summary is due by end of POP via email.

10% of award for final modules each (20% total)

Education metric report Due by end of POP 5% of award Electronic checklists Due by end of POP 5% of award each (10% total) User guides for electronic forms Due by end of POP 10% of award

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

PERFORMANCE-BASED WORK STATEMENT

OVERVIEW

The Centers for Disease Control and Prevention’s (CDC) Dialysis team in the Prevention and Response Branch has responsibility for defining and implementing evidence-based infection control practices in outpatient dialysis centers throughout the United States, including U.S. territories. The Dialysis team also responds to outbreaks of healthcare-associated infections or other adverse events in healthcare settings, and increasingly uses data to target and evaluate interventions. The U.S. experience with Ebola highlighted the critical importance of infection prevention programs. Several patients infected with Ebola who were treated in the United States—including one who transmitted the infection to two nurses— had developed acute renal failure requiring hemodialysis.

Dialysis facilities are a current focus of the Prevention and Response Branch given the data and recent concerns identified in that area. CDC is engaged in a number of initiatives aimed at improving infection control practices in dialysis facilities across the country. For several years, CDC has been working to promote uptake among dialysis providers of recommended practices to prevent bloodstream infections (BSI) and hepatitis C virus (HCV) infections. CDC has developed a suite of publicly available prevention tools, training videos, and other materials that facilities can use to implement interventions aimed at dialysis BSI reduction. CDC has also supported reporting of BSIs and related infections in dialysis patients from >6,000 U.S. dialysis centers to a national surveillance system, giving dialysis providers real-time data to help them track progress toward reducing infections. CDC provides technical assistance to dialysis provider organizations, state and local health departments, the Centers for Medicare and Medicaid Services End Stage Renal Disease Networks, and other partners working to educate dialysis healthcare personnel about infection prevention practices; improve and implement infection control best practices in dialysis centers; and reduce BSIs, HCV transmission, and other infections among dialysis patients. CDC currently needs support to find and deliver new and better strategies for achieving reductions in the overall burden of BSIs and other healthcare-related infections in dialysis patients.

This task order will develop patient education and safety materials informed and piloted by patients and patient advocates to explore a patient driven direction for infection prevention efforts in the dialysis setting. This work will develop patient training materials, patient infection prevention-focused modules, a patient dialysis safety webinar series, live educational sessions, audit tools and checklists, and a variety of social media messaging targeted to the patient to promote prevention practices and protect the public from healthcare associated infections.

PROJECT GOALS

The goal of this task order is to develop a variety of patient education materials to promote infection prevention practices in the dialysis setting.

CDC is requesting proposals in which the Contractor:

• Identifies and develops a group of nephrology experts, patient advocates, and current dialysis patients as expert panels or focus groups (n<9) to become advisors in the development of the materials listed in this scope of work.

• Develops patient education tools and materials that can be made freely available to patients for rapid uptake and use in self-protection in the dialysis facility or in the home setting using dialysis equipment.

• Delivers patient education through webinar, web portal, patient accessible mobile application/checklist or other readily understandable and patient obtainable pathway for understanding of areas of risk and opportunities for infection prevention.

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

SCOPE OF WORK

The purpose of this acquisition is to improve infection prevention and control efforts and decrease infection events in dialysis facilities across the United States through increased patient education and awareness.

Particularly in this setting and as patients are increasingly moving toward in-home dialysis care, increased understanding of infection prevention methods by the patient is relevant in addition to provider understanding to decrease risk to the patient and provider for poor outcomes. Under this work, the contractor will create patient education and training materials and potentially inform future efforts toward dialysis infection prevention efforts in multiple areas.

TASKS TO BE PERFORMED

The contractor shall provide all labor, expertise, materials, and supplies as well as perform all services required to carry out the work under this contract.

Task A: COMMUNICATION

1. The Contractor shall arrange and conduct an initial meeting (by teleconference) with the CDC

Contracting Officer Representative (COR), and other relevant staff within two weeks of the effective date of the task order. The purpose of the meeting will be to confirm critical contract performance milestones and roles and responsibilities that will be taken on by the Contractor, and to establish communication protocols (such as a regular call schedule). Each task and deliverable will be reviewed. The Contractor shall submit an agenda for the above meeting within one week of the effective date of the task order.

2. The Contractor shall coordinate with the COR and Science Officer(s) at least monthly by teleconference to go over progress, challenges, and to ensure project is on track. Additional calls may be scheduled as needed by the COR if determined necessary. The Contractor shall provide an agenda and meeting minutes for each call. All conference calls shall be scheduled and administered by the Contractor.

3. The Contractor shall respond to all emails and telephone communications from the COR or Science Officer within three business days.

Task B: Needs Assessment Home Dialysis

1. Conduct a needs assessment evaluation with involvement from active members of the Nephrology/Dialysis community such as providers or technicians, dialysis patient advocates, infection preventionist(s). and active dialysis patients to identify barriers and facilitators that impact patient safety including those with active home dialysis programs to identify infection control and training challenges, barriers, and opportunities.

2. The contractor shall arrange and attend site visits for the panel/group described above to observe at least 4 facilities including home hemodialysis and peritoneal dialysis sites together to discuss together opportunities for education or patient driven infection prevention opportunities that could inform patient education materials.

a. At each location, as a group, perform numerous observations in the facility and multiple (at least

3) patient home(s) spanning at least 3 days to ensure representativeness of observations.

b. Facilities selected for site visits should include dialysis programs that provide home hemodialysis and/or peritoneal dialysis. CDC COR and technical lead should review and agree on selected list of facilities and characteristics before final scheduling occurs.

c. Conduct observations and assessments during these site visits focused on identifying gaps in infection prevention and training practices that impact patient safety.

d. In each setting, evaluate interactions between people, technology, work and care environments, and systems that influence adherence to infection prevention practices and other infection risks in order to identify barriers and facilitators to adherence.

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

3. The contractor shall provide informal feedback and describe key activities and/or findings at each facility within 3 weeks of the conclusion of visits for each location.

4. The contractor shall produce one final report describing key activities and findings, including the barriers and facilitators identified, limitations, conclusions, and recommendations for training opportunities or patient education to CDC on the basis of the evaluations and any additional knowledge the contractor may have obtained relevant to the goals of this task. Include any other relevant findings that support the conclusions and recommendations made to CDC. If sites visited made changes post-visit due to this activity, detail any relevant changes or actions or findings that were completed at facilities following the site visits and recommendations made. Include recommendations to CDC of next steps or follow up activities that may be useful in bringing these analyses to public health infection prevention action.

(Raw data is not to be provided to CDC.)

Task C: Hold Advisory or Focus Group

1. Reassembling group from Task B, hold meeting(s) to discuss and set agenda/outline for development of patient material for Tasks D and E. This group should meet at least 4 times over the course of development and within PoP to advise contractor on development with the patient in mind. In addition to advising on development of materials, workgroup/panel will review and advise on future educational gaps and target areas for distribution of educational resources through social media platforms, promotion opportunities, and educational webinars. Contractor will provide to CDC quarterly a summary of opportunities or needs identified by committee. Contractor will consider findings in the development of items under Tasks D & E. Meeting minutes should be delivered to CDC COR within 2 weeks following meeting date.

Task D: Patient Educational Trainings

1. Based on learning from Tasks B&C, contractor shall develop, produce, and present two 20-30 minute educational webinars for the kidney community focused on infection prevention and patient safety among dialysis patients. The webinar platform utilized should have space for 1,000 or more live attendees. Each webinar shall be recorded for enduring education through the vendor’s website or hosting platform for the entirety of PoP. Recorded webinar content will be made available to CDC and the public within 60 days from presentation. Webinar should be targeted to patients and communication geared toward that audience specifically. Content should be driven by Task B and C findings, but outline and presentation materials should be reviewed by CDC in advance of delivery. CDC shall review educational content with at least 30 days to comment and request changes before delivery. During period of performance and after posting, vendor will provide monthly access numbers to CDC.

2. Based on learning from Tasks B&C, contractor shall develop educational dialysis patient infection prevention and safety modules. The educational modules will be built to target an audience dialysis patients and cover patient safety topics related to dialysis care within a facility and in the home setting.

Training will include two case-based learning modules. Course must be 508 compliant. Educational total seat time should be around 20 minutes for each module. Course should be made active on the contractor’s website for free use during PoP and delivered to CDC at PoP end. Numbers of learners and methods of delivery should be reported at contract end. CDC should have at least 15 days to review preliminary draft of module. CDC should have at least 30 days to review and provide requested edits on the final product prior to delivery of educational item. CDC will own content at contract end.

3. Produce one report by end of POP detailing education and engagement metrics for each product created.

Task E: Patient Education and Engagement

1. Vendor shall develop and trial an electronic responsive form (fillable by tablet or mobile device) based on CDC infection control audit tools and chairside checklists to be utilized by patients in dialysis facilities for:

a. Catheter Connection and Disconnection Audit and Checklist (patients)

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

b. Hand Hygiene (staff and patients)

2. Vendor shall create user guide and education for implementation of electronic responsive forms with embedded video instructions into the electronic responsive form. Forms and instructions should be aligned with CDC content and recommendations. Created electronically fillable item will be delivered to CDC by email in a format CDC agrees to.

The Government will not provide any hardware or software or equipment/supplies for this project. No Government furnished property will be supplied to the contractor.

DELIVERABLES SUMMARY TABLE/REPORTING SCHEDULE

The following deliverables shall be provided to the Contracting Officer Representative (COR) and Science Officer no later than the dates specified below:

Base Task

Task Description Deliverable Quantity/ Frequency

Due Date

A Kick off Meeting Agenda; Attendance 1 Within 2 weeks of task order award, hold meeting with contractor representatives, COR, and CDC technical advisors to go over all tasks and provide any clarification needed.

A Monthly teleconference Agenda, Attendance, minutes

11 Monthly

B Facility/site/home(s) assessment document

Deliver a brief, high-level report to document key activities and/or findings at each facility within 3 weeks of the conclusion of visits for each location for a total of 4 documents. Reports should be delivered electronically to the COR.

4 For each site, key findings document is due to the COR 3 weeks after conclusion of last study visit at that site and before end of period of performance in Microsoft Word format.

B Assessment document – combination of all site visit findings and recommendations to CDC

Deliver a detailed final report describing the barriers and facilitators identified, limitations, conclusions, and recommendations to CDC to improve infection control practices in US dialysis centers on the basis of the evaluation. Include any other relevant findings that support the conclusions and recommendations made to CDC particularly related to patient education and safety.

1 Final recommendations document is due in Microsoft Word format to the COR by the end of the

POP

C Minutes from Deliver minutes from 4 Within 2 weeks following

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

GENERAL INFORMATION

A. Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility and associated academic, healthcare or research facilities as required.

B. Type of Contract: The government will award a Firm-fixed price contract.

workgroup/focus groups quarterly workgroup meeting to CDC in Microsoft Word or Adobe PDF format meeting date and before end of POP.

D 20-30 minute educational webinars for the kidney community.

PowerPoint slides (or other agreed upon format) delivered by email to COR and technical monitors.

2 draft, 2 final

Draft due to CDC 30 days before educational delivery.

Final delivered content due to CDC within 60 days post-presentation and before end of POP.

D Educational dialysis patient infection prevention and safety case-based learning modules.

PowerPoint slides (or other agreed upon format) delivered by email to COR and technical monitors.

2 draft, 2 final presentation;

Final will be accessed by CDC through vendor website and should be delivered to CDC directly on live date in PowerPoint or other agreed format.

CDC should have at least 15 days to review preliminary draft of module. CDC should have at least 30 days to review and provide requested edits on the final product prior to delivery of educational item.

D Education metric report Report on education and promotion metrics from Task D

1 Microsoft Word document

By end of POP

E Electronic checklists electronic responsive form, Adobe format unless otherwise agreed

2 Deliver to CDC by email in Adobe or other agreed format in final form by end of POP; draft should be reviewed by CDC at least 30 days in advance of finalization.

E User guides for electronic forms

User guide and education for implementation of new tools

2 Deliver to CDC by email in Adobe or other agreed format in final form by end of POP; draft should be reviewed by CDC at least 30 days in advance of finalization.

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

C. Contractor Travel: The cost associate with completing the work/task, should be part of the task cost (i.e

CLIN 0001).

D. Confidentiality of Information: Work on this project may require that personnel have access to Privacy Information. Personnel shall adhere to the Privacy act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

E. Government Furnished Property, Equipment, and Services Not Applicable

Special Clearances:

Check all that apply: Comments

OMB

Human Subjects Privacy Act Appropriate security controls and Rules of Behavior should be incorporated to protect the confidentiality of information, proprietary, sensitive, and Personally Identifiable Information (PII) the Contractor may come in contact with during the performance of this contract.

IT Security IT Contractor performance and resulting deliverables must adhere to all federal, HHS, and/or CDC IT security policies and procedures. Based upon the scope of this contract, the SOW must include the appropriate language to address the following IT security topics:

Standard for Security Configurations; Standard for Encryption Language; and Security requirements for Federal Information technology Resources.

A. Confidentiality of Information: Work on this project may require that personnel have access to Privacy

Information. Personnel shall adhere to the Privacy Act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

B. Section 508 Compliance

By agreeing to the terms of the Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD) Program IDIQ Contract, the offeror must comply with Section 508 standards for all deliverables in this task order. The offeror must complete an HHS/CDC checklist(s) as needed for each deliverable specified.

The applicable Section 508 standards to this task order are 1194.

302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

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INVOICING INSTRUCTIONS

Invoice Submission - CDCAG001 – Invoice Submission (Mar 2006)

(a) The Contractor is required to submit the original invoice/voucher directly to the Financial Management Office using one (1) of three (3) methods (but only one method). Invoices shall not be submitted more frequently than one (1) time per month.

(1) By Email: fmoapinv@cdc.gov (the best and preferred method. See paragraph (b).)

(2) By Facsimile: FAX 404-638-5324

(3) By Mail to: The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 30333

(b) The contractor shall submit the original invoices/vouchers to the CDC FMO, the COR, and the

Contracting Officer (CO). The preferred method for doing so is to simultaneously email electronic files of the invoice and any backup documents to each of the three (3) parties.

(c) The Contractor is , is not required to submit a copy of each invoice directly to the Contracting

Officers Representative concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment Act), CDC's Financial Management Office (FMO) is the designated billing office for the purpose of determining the payment due date under FAR 32.904(b); the controlling “date of receipt” of an invoice is the date on which the FMO receives a proper invoice from the contractor.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, as appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number (CLIN) and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (e) (1).

(13) DUNS + 4 Number

(End of Clause) mailto:FMOAPINV@CDC.GOV

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

TASK ORDER CLAUSES

APPLICABLE FAR CLAUSES:

52.246-7 Inspection of Research and Development—Fixed-Price (Aug 1996) 52.246-9 Inspection of Research and Development (Short Form) (Apr 1984) 52.232-2 Payments under Fixed-Price Research and Development Contracts (Apr 1984)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Oct 2020)

(a) Definitions. As used in this clause— Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network).

Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).

Covered foreign country means The People’s Republic of China.

Covered telecommunications equipment or services means–

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3) Telecommunications or video surveillance services provided by such entities or using such equipment;

or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means–

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled-

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

Interconnection arrangements means arrangements governing the physical connection of two or more networks to allow the use of another's network to hand off traffic where it is ultimately delivered (e.g., connection

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

of a customer of telephone provider A to a customer of telephone company B) or sharing data and other information resources.

Reasonable inquiry means an inquiry designed to uncover any information in the entity's possession about the identity of the producer or provider of covered telecommunications equipment or services used by the entity that excludes the need to include an internal or third-party audit.

Roaming means cellular communications services (e.g., voice, video, data) received from a visited network when unable to connect to the facilities of the home network either because signal coverage is too weak or because traffic is too high.

Substantial or essential component means any component necessary for the proper function or performance of a piece of equipment, system, or service.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. The Contractor is prohibited from providing to the Government any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in

FAR 4.2104.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract, or extending or renewing a contract, with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered telecommunication equipment or services are covered by a waiver described in FAR 4.2104. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract.

(c) Exceptions. This clause does not prohibit contractors from providing—

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(d) Reporting requirement.

(1) In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or essential component of any system, or as critical technology as part of any system, during contract performance, or the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are established procedures for reporting the information; in the case of the Department of Defense, the Contractor shall report to the website at https://dibnet.dod.mil. For indefinite delivery contracts, the Contractor shall report to the Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in the case of the Department of Defense, identify both the indefinite delivery contract and any affected orders in the report provided at https://dibnet.dod.mil.

(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause

(i) Within one business day from the date of such identification or notification: the contract number; the order number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial and Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number, manufacturer part number, or wholesaler number); item description; and any readily available information about mitigation actions undertaken or recommended.

https://www.acquisition.gov/far/part-4#FAR_4_2104 https://www.acquisition.gov/far/part-4#FAR_4_2104 https://dibnet.dod.mil/ https://dibnet.dod.mil/

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(ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: any further available information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of covered telecommunications equipment or services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.

(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e) and excluding paragraph (b)(2), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial items.

(End of clause)

FAR 52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days prior to expiration of the contract.

FAR 52.227-14 Rights in Data-General, Alternate IV (Dec 2007) As prescribed in 27.409(b) (5), substitute the following paragraph (c) (1) for paragraph (c) (1) of the basic clause:

(c) Copyright—(1) Data first produced in the performance of the contract. Except as otherwise specifically provided in this contract, the Offeror may assert copyright in any data first produced in the performance of this contract. When asserting copyright, the Offeror shall affix the applicable copyright notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number), to the data when such data are delivered to the Government, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. For data other than computer software, the Offeror grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For computer software, the Offeror grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public), by or on behalf of the Government.

HHSAR 352.224-70, Privacy Act (Dec 2015) This contract requires the Contractor to perform one or more of the following:

(This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a (i)).The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement: (a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

HSSAR 352.270-4a Notice to Offerors, Protection of Human Subjects (December 18, 2015)

(a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at:

http://www.hhs.gov/ohrp/index.html.

These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.

(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

(c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.101(b) (1)-

(6) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.

(e) In accordance with 45 CFR part 46, offerors considered for award shall file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board shall ensure that: the risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply; see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP website (at http://www.hhs.gov/ohrp/assurances/index.html).

(f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. ONLY the contracting officer may offer information concerning a solicitation.

(g) The offeror shall document in its proposal the approved FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research. If the offeror does not have an approved FWA from OHRP, the offeror must obtain an FWA before the deadline for proposal submission. When possible, the offeror shall also certify the IRB’s review and approval of the research. If the offeror cannot obtain this certification by the time of proposal submission they must include an explanation in their proposal. Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research’s review and approval by the

IRB.

(End of provision)

HHSAR 352.270-4b Protection of Human Subjects (December 18, 2015)

(a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor’s current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

http://www.hhs.gov/ohrp/index.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 http://www.hhs.gov/ohrp/assurances/index.html

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

(b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

(c) Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as agents of the institution or via individual investigator agreements (see OHRP website at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).

(d) If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.

(End of clause)

HHSAR 352.270-12 Needle Exchange (December 18, 2015) The Contractor shall not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

(End of Clause)

CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Apr 2015) In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf http://www.cpars.gov/

ATTACHMENT 3 SAMPLE TASK ORDER DOMAIN 3

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated.

Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

CDC H049 Non-Disclosure Agreement for Contractor and Contractor Employees (Jun 2020)

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