20200526 - 75D301-20-R-68007 - Request for Proposal (RFP).pdf

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Attached to
Dialysis Infection Prevention Federal contract opportunity
Solicitation number
75D301-20-R-68007
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

About this file

This document outlines a request for proposal for professional services related to infection prevention in dialysis facilities issued by the Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services. The required services include conducting a needs assessment of home dialysis, developing and leading an expert project committee, developing and presenting educational webinars, and developing an educational training tool for patients on dialysis. Proposals are due no later than 2:00pm ET on June 25, 2020 and shall be submitted electronically via email. The services will be for a period of twelve months from the date of award. Payment will be made according to a deliverable schedule with amounts ranging from 2.5% to 10% of the total contract value for individual deliverables. Inquiries regarding the RFP must be received by email no later than 2:00pm ET on May 28, 2020.

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PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 63

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-20-R-68007

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

05/26/2020

6. REQUISITION/PURCHASE

NO.

00HCVLD1-2020-42229

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 2:00p local time 06/25/2020

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Lee Catherine Kennedy

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2673

C. E-MAIL ADDRESS

vhg0@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 40

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 5 X J LIST OF ATTACHMENTS 44

X D PACKAGING AND MARKING 11 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 12 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 13 X K OTHER STATEMENTS OF OFFERORS 45

X G CONTRACT ADMINISTRATION DATA 15 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 52

X H SPECIAL CONTRACT REQUIREMENTS 19 X M EVALUATION FACTORS FOR AWARD 61

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K mailto:vhg0@cdc.gov

Section B – Supplies or Services and Prices/Costs

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Professional Services Related to Needs Assessment of Home Dialysis

This is a fixed-price CLIN. Services performed under this CLIN are considered nonseverable services.

Work to be performed in accordance with Section C –

Description/Specification/Work Statement. Payments shall be made in accordance with Section B.4 Deliverable/Milestone Payment Schedule.

Period of Performance: 12 months from date of award

1 Job

NOT TO EXCEED:

0002 Travel

(Reimbursed for cost only.)

All travel must be preapproved by the Government prior to Contractor invoicing. All travel will be reimbursed in accordance with the Federal Travel Regulation

(FTR).

Period of Performance: 12 months from date of award

1 Job $ $

Total: $

B.2 Contract Type

The Government anticipates awarding a fixed-price contract. Services performed are anticipated to be nonseverable services. Services performed are also anticipated to be exempt from the Service Contract Labor Standards (SCLS).

B.3 Points of Contact

Government and Contractor Points of Contact will be identified at the time of contract award. All inquiries regarding this requirement shall be directed to the Contract Specialist and Contracting Office noted on p. 1 of this Request for Proposal (RFP).

B.4 Deliverables/Milestones Payment Schedule

The Government anticipates the following deliverable/milestone payment schedule.

Deliverable Due Date Delivery Format

Payment Percentage

(of total contract value)

Payment Amount

HFE assessment document – specific to a single site visit finding due 3 weeks after conclusion of last study visit at specific site

5% per report

(20% total)

HFE assessment document – combination of all site visit findings and high-level recommendations to

CDC

final recommendations document by the end of the Period of Performance

(PoP)

5% $

Minutes from Nephrologists Transforming Dialysis Safety (NTDS) Project Committee workgroup within 2 weeks following meeting date and before the end of the PoP

2.5% each

(10% total)

Minutes from NTDS sub-committees on specific needs areas defined including recommendations for improvement (education, marketing, etc.)

within 2 weeks following meeting date and before the end of the PoP

2.5% each

(10% total)

Two 60-minute educational webinars for the kidney community focused on infection prevention and patient safety among dialysis patients. CDC shall review educational content with at least 30 days to comment and request changes before delivery.

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

10% each final delivered item

(20% total)

Offerors are invited to propose an alternate deliverable/milestone payment schedule based on Section C – Description/Specification/Work Statement. The Government reserves the right to negotiate changes to the proposed deliverable/milestone payment schedule before incorporating into the finalized contract.

Deliverable Due Date Delivery Format

Payment Percentage

(of total contract value)

Payment Amount

Educational infection prevention and patient safety modules with infection prevention and/or patient safety questions for the nephrology board exam and including one case-based learning module

Draft modules due by February 15, 2021. Final will be accessed by the Government through Contractor’s website and should be delivered to the Government directly on live date in

PowerPoint or other agreed upon format.

Final summary is due by the end of the PoP via email.

5% each for final modules

(10% total)

Report on education promotion and metrics due by the end of the PoP

5% $

Educational infection prevention and patient safety tool due by the end of the PoP

10% $

Electronic checklists deliver to the Government via email in Adobe or other agreed upon format by the end of the

PoP

2.5% each for final delivered checklist

(5% total)

User guides for electronic forms deliver to the Government via email in Adobe or other agreed upon format by the end of the

PoP

2.5% each for final delivered user guide

(5% total)

Total: $

Section C – Description/Specification/Work Statement

Title: Promoting Infection Prevention in Dialysis Facilities

SECTION 1 – BACKGROUND

The mission of 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. The process of performing hemodialysis on these patients who typically have high titers of the Ebola virus in their blood introduced unique infection control challenges not previously encountered in this country. Nephrologists remain an important part of the teams that have provided and will provide care for patients infected with Ebola. Translating these lessons learned from Ebola, including the importance of core infection prevention practices such as use of personal protective equipment, not just to hospitals, but to all places where individuals receive healthcare, is a significant opportunity to increase the safety of all U.S. healthcare facilities.

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 and promote those fundings through nephrology audiences by distributing findings, materials, and recommendations to nephrologists as influential leaders in 4 priority infection prevention areas.

These areas are: 1) improving adherence to recommended infection prevention practices, 2) improving screening and detection of infections spread through contact and reduce the spread of these infections in dialysis settings, 3) increasing implementation of clinical protocols to ensure accurate detection and appropriate treatment of infections, and 4) improve collaboration between nephrologists and state and federal healthcare-associated infection programs.

CDC has previously obtained support in this area using contracts with the American Society of Nephrology, Inc. (ASN) (awards 200-2016-88832 and 75D30119C05397) which has yielded the development of training materials and infection prevention-focused webpages, a Targeting Zero Infections webinar series, live educational sessions, audit tools and checklists, and a variety of publications and regular social media messaging which has pushed forward engaging strong nephrologist leaders to cultivate a climate that assures patient safety by preventing infections.

Through these awards, CDC has created a Nephrology Community which was brought together to implement infection prevention and describe best practices. This community represents a great resource for CDC identifying barriers and facilitators to adherence to CDC-recommended infection prevention practices.

The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), Prevention and Response Branch (PRB) requires support to enhance infection control for all infectious threats in U.S. dialysis facilities to protect both patients and healthcare personnel by continuing to identify barriers and facilitators in the Nephrology Community and dialysis centers to promote prevention practices and protect the public from healthcare associated infections.

SECTION 2 – SCOPE OF WORK

The purpose of this requirement is to improve infection prevention and control efforts in dialysis facilities across the United States through evaluation of improved methodologies and distribution of findings to relevant nephrology groups. This will be done by performing a needs assessment evaluation in relevant areas and looking for opportunities for improvement. Those findings will inform efforts for educational and trainings targeted to practitioners and the public to improve safety in dialysis facilities.

SECTION 3 – 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 1: Human Factors Engineering

Needs Assessment of Home Dialysis

Contractor shall conduct a needs assessment evaluation with Human Factors Engineering (HFE) expert(s) with involvement from the Nephrologists Transforming Dialysis Safety (NTDS) Project Committee (see Task 2) to identify barriers and facilitators that impact patient safety with active home dialysis programs to identify infection control and training challenges, barriers, and opportunities. HFE expert(s) should be credentialed with a Ph.D. in engineering psychology, human factors engineering, experimental psychology, cognitive psychology, industrial engineering or a related field or a similar Master’s degree and should have relevant healthcare industry experience in order to be able to assess barriers and facilitators to adherence to recommended infection prevention practices and patient training.

1. The Contractor shall arrange and attend site visits for the HFE expert(s), at least 1 NTDS project committee member, at least 1 individual with relevant infection prevention expertise, and other relevant advisory staff to at least 4 facilities, including home hemodialysis and peritoneal dialysis, not previously used for this type of evaluation.

a. At each location, the Contractor shall 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. The Government will review and approve the selected list of facilities and characteristics before final scheduling occurs.

c. Contractor shall 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, Contractor shall evaluate human factors and 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.

e. Arrange for the Government to attend and participate in these site visits, if desired, at each facility and patient homes. Contractor will assist arrangement of additional visits by the Government for follow up, if necessary. The Government will fund all travel expenses for Government personnel.

2. 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.

3. The Contractor shall produce one final report describing key activities and findings, including the barriers and facilitators identified, limitations, conclusions, and recommendations to the Government on the basis of the evaluations and any additional knowledge the Contractor may have. Include any other relevant findings that support the conclusions and recommendations made to the Government. 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 the Government of next steps or follow up activities that may be useful in bringing these analyses to public health infection prevention action.

(Contractor shall not provide raw data to the Government.)

Task 2: Develop, Maintain, and Lead Dialysis/Nephrologist Expert Project Committee and Workgroup

1. Contractor shall establish and maintain an expert Nephrologists Transforming Dialysis Safety (NTDS) Project Committee workgroup consisting of experts across relevant disciplines to inform infection prevention and patient safety efforts. Committee shall have at least 5 Nephrologists including those with operational dialysis knowledge, at least 1 dialysis nurse, at least 1 dialysis technician, at least 1 vascular surgeon, at least 1 infection preventionist, at least 1 patient on (or formerly on) hemodialysis, at least 1 biomed technician, and at least 1 infectious disease physician. Committee of dialysis subject matter experts will meet quarterly (4 times total with at least one time in-person) to provide clinical expertise to the Government on:

a. Marketing Communications – Workgroup will review documents provided by the Government and apply clinical expertise to the Government on materials. Group will comment on best most effective marketing avenues based on specific knowledge gained through their various expertise and daily interaction with patients and facilities in the areas of concern. Committee will provide guidance to Contractor of known or perceived best opportunities to promote the infection prevention materials and resources provided considering journal articles, social or web platforms, or other methods. Project committee will assist in social media or email dissemination of new Making Dialysis Safer for Patients Coalition materials. Committee will provide to the Government a written summary of recommendations from the committee.

b. Educational opportunities – Workgroup will review and advise the Government on educational gaps and target areas for providing educational resources through social media platforms, promotion opportunities, and educational webinars. Contractor shall provide to the Government quarterly a summary of opportunities or needs identified by committee. Contractor shall consider findings in the development of items under Task 3.

c. Clinical guides and other practitioner targeted practical information related to current and emerging infectious threats including input on implementing additional precautions proposed in outpatient hemodialysis facilities.

d. Contractor shall schedule meetings in consideration of Government availability for attendance at these 4 meetings. The Government can decline to attend.

e. Meeting minutes should be delivered to the Contracting Officer’s Representative (COR) within 2 weeks following meeting date.

2. Committee will also establish workgroups for each area (a-d) to meet 4 times each (remotely is acceptable) to discuss specific needs areas and make recommendations to the Government in real time and with meeting minutes on specific needs and areas of improvement (education, marketing, etc.) and to provide a strategic action plan by end of quarter 1 in the following areas:

a. Alternative Dialysis Settings with potential to impact patient safety e.g., identify infection prevention and control issues in nursing homes and patients’ homes)

b. Vascular Access to identify issues in the dialysis setting and how improvements can be best affected by CDC interventions.

c. Quality, Assessment, Improvement, & Education (QAIE) Education to identify education gaps for providers and patients.

d. Continuing and Emerging Threats to identify issues related to bloodborne pathogens, bloodstream infections, staphylococcus aureus infections Hepatitis C testing, multi-drug resistant organisms (MDROs), blood culturing standardization practices, and antibiotic use.

Task 3: Provide Educational Training

1. Contractor shall develop, produce, and present two 60-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 and provide continuing education credits for kidney community providers through the Contractor’s website or hosting platform. Recorded webinar content will be made available to the Government and the public within 60 days from presentation. During contract Period of Performance, Contractor shall provide quarterly access numbers to the Government. The Government will review educational content with at least 30 days to comment and request changes before delivery.

2. Contractor shall develop educational infection prevention and patient safety modules. The educational modules will be built to target an audience of nephrology leadership including physicians, medical directors, advance practice nurses, and other leaders at dialysis facilities.

Training will include two case-based learning modules focused on antibiotic prescribing and other topic to be decided in conjunction with the Government. Course shall be 508 compliant. Educational total seat time should be at least 20 minutes for each module. Course should be made active on the ASN website for free use by end of performance. Numbers of learners and methods of delivery should be reported at the end of the contract Period of Performance. The Government will have at least 15 days to review preliminary draft of module. The Government will have at least 30 days to review and provide requested edits on the final product prior to delivery of educational item. The Government will own content at the end of the contract Period of Performance.

3. Contractor shall produce one report by the end of the Period of Performance detailing education and engagement metrics for each product created or promoted through this work or through coalition efforts to educate the kidney community about infection prevention and expand the reach of NTDS to those who may not otherwise know about the project.

Task 4: Patient and Staff Education and Engagement

1. Contractor shall develop an educational infection prevention and patient safety training tool to target an audience of patients on dialysis. Training must include case-based learning focused on patient engagement. If part of the course is electronic, it shall be 508 compliant.

Educational total seat time should be at least 30 minutes. The Government will have at least 15 days to review preliminary draft of module. The Government will have at least 30 days to review and provide requested edits on the final product prior to delivery of educational item.

The Government will own the educational information at the end of the contract Period of Performance.

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

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

b. Hand Hygiene (staff and patients)

Contractor 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 Government content and recommendations. Created electronically fillable item will be delivered to the Government by email in a format agreed upon by the Government.

SECTION 4 – GOVERNMENT–FURNISHED EQUIPMENT, MATERIALS, AND/OR

PROPERTY

There is no Government-furnished equipment, materials, and/or property associated with the anticipated contract.

SECTION 5 – PERIOD OF PERFORMANCE

The anticipated Period of Performance is twelve months from date of award. Specific Period of Performance dates anticipated are from 23 July 2020 through 22 July 2021.

SECTION 6 – MINIMUM VENDOR QUALIFICATIONS

1. Vendor must have existing relationship with Human Factors Engineering (HFE) experts available or identified who also have relevant training and understanding of the field of dialysis and nephrology.

2. Vendor must have access to and existing relationships with Nephrology experts as identified in Task 2 in order to be able to successfully and quickly create required advisory committee.

Section D – Packaging and Marking

There are no clauses/provisions included in this section.

Section E – Inspection and Acceptance

FAR SOURCE TITLE AND DATE

52.246–4 Inspection of Services—Fixed-Price (August 1996)

E.1 Inspection and Acceptance

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the Contracting Officer’s Representative (COR)) at the destination of the articles, services, or documentation.

Section F – Deliveries or Performance

FAR SOURCE TITLE AND DATE

52.242–15 Stop Work Order (August 1989) 52.242–17 Government Delay of Work (April 1984) 52.247–34 F.O.B. Destination (November 1991)

F.1 Place of Performance

The anticipated Place of Performance is at Contractor’s facility and offsite locations. Government facilities may be available for incidental use, such as a quarterly meeting, but the Government will not provide dedicated workspace for Contractor employees on Government facilities.

(End of Clause)

F.2 Deliverables and/or Reporting Schedule

This is the anticipated Deliverables and/or Reporting Schedule.

Base Task

Task Description Deliverable Quantity/ Frequency

Due Date

1 HFE assessment document

– specific to a single site visit finding

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.

1 HFE assessment document

– combination of all site visit findings and high-level 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.

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

2 Minutes from Nephrologists Transforming Dialysis Safety (NTDS) Project Committee workgroup

Deliver minutes from quarterly NTDS project committee workgroup meeting to CDC in Microsoft Word or Adobe PDF format

4 Within 2 weeks following meeting date and before end of

POP.

2 Minutes from NTDS sub-committees on specific needs areas defined including recommendations for improvement (education, marketing, etc.)

Deliver combined or workgroup by workgroup

4 Within 2 weeks following meeting date and before end of

POP.

3 Two 60-minute educational webinars for the kidney community focused on infection prevention and patient safety among dialysis patients. CDC shall review educational content with at least 30 days to comment and request changes before delivery.

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.

3 Educational infection prevention and patient safety modules with infection prevention and/or patient safety questions for the nephrology board exam and including one case-based learning module

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

2 draft, 2 final presentation;

Draft modules due by February 23, 2021. Final will be accessed by CDC through Contractor website and should be delivered to CDC directly on live date in PowerPoint or other agreed format.

3 Education metric report Report on education and promotion metrics

1 Microsoft Word document

By end of POP

4 Educational infection prevention and patient safety tool

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

1 draft, 1 final By end of POP

4 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.

4 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.

Section G – Contract Administration Data

G.1 Government Representatives

Contracting Officer The Contracting Officer will be identified at the time of contract award.

Contracting Officer’s Representative (COR)

The COR will be identified at the time of contract award.

G.2 CDC0_G008 Contracting Officer’s Representative (COR) (July 2017)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR Delegation Memorandum upon request.

(End of Clause)

G.3 CDCP_G009 Contracting Officer (July 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.4 CDCA_G001 – Invoice Submission (July 2017)

(a) The Contractor shall submit the original contract invoice/voucher to the address shown below:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333

Or – The Contractor may submit the original invoice via facsimile or email:

Fax: (404) 638–5324

Email: fmoapinv@cdc.gov

NOTE: Submit to only one (1) of the above locations.

(b) The Contractor shall submit one (1) copy of the invoice to the cognizant contracting office previously identified in this contract. This invoice copy shall be addressed to the attention of the Contracting Officer.

(c) The Contractor is required to submit a copy of each invoice directly to the Contracting Officer’s Representative (COR) concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC’s OFR is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(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/Delivery Order/Task Order/Contract 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 (c) (1)

(13) DUNS + 4 Number mailto:FMOAPINV@CDC.GOV

(14) Electronic funds transfer (EFT) banking information

G.5 CDC0_G018 Payment by Electronic Funds Transfer (February 2018)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232–33, Payment by Electronic Funds Transfer – System for Award Management, in Section I, requires the Contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232–34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below.

The Contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J – List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Office of Financial Resources at (678) 475– 4510.

(c) In cases where the Contractor has previously provided such information, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control & Prevention (CDC) Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: (404) 638–5342

(End of Clause)

G.6 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 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.

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.

(End of Clause)

G.7 Contract Communications/Correspondence (July 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

http://www.cpars.gov/

Section H – Special Contract Requirements

H.1 Security and Privacy Language

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any Subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to Government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any Subcontractor) will operate a Federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any Subcontractor) shall:

a. Protect Government information and information systems in order to ensure:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of Government information and Government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [x] Low [ ] Moderate [ ] High Integrity: [x] Low [ ] Moderate [ ] High Availability: [x] Low [ ] Moderate [ ] High Overall Risk Level: [x] Low [ ] Moderate [ ] High

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[x] No PII [ ] Yes PII

Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother’s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [x] Low [ ] Moderate [ ] High

4) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any Subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, reusing, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

mailto:fisma@hhs.gov

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

5) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any Subcontractor) shall protect all Government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

6) Confidentiality and Nondisclosure of Information. Any information provided to the Contractor (and/or any Subcontractor) by HHS or collected by the Contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and Subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its Subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or Subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and CDC policies. Unauthorized disclosure of information will be subject to the HHS/CDC sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

8) Government Websites. All new and existing public-facing Government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9) Contract Documentation. The Contractor shall use provided templates, policies, forms and other Agency documents to comply with contract deliverables as appropriate.

See Section F – Deliveries or Performance for baseline deliverables.

10) Standard for Encryption. The Contractor (and/or any Subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to Government information.

b. Encrypt all sensitive Federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process Government information and ensure devices meet HHS and CDC-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive Government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2.

The Contractor shall provide a written copy of the validation documentation to the

COR.

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys.

Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

11) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any Subcontractor) employee having access to non-public Government information under this contract shall complete the CDC non-disclosure agreement. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

See Attachment 1 for the HHS Contractor Non-Disclosure Agreement.

12) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy (SOP) or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist the CDC SOP or designee with completing a PIA for the system or information within fourteen (14) calendar days after completion of the PTA and in accordance with

HHS…

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