RFP 75D30122 R72138.pdf

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 60

2. CONTRACT NO.

75D30122 C13118

3. SOLICITATION NO.

75D30122 R72138

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

12/20/2021

6. REQUISITION/PURCHASE

NO.

000HCCLG-2022-53132

7. ISSUED BY CODE 436 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 626 Cochrans Mill Rd Pittsburgh, PA 15236-0070

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 1 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 1 electronic copy to ygf3@cdc.gov until 11:00AM local time 02/28/2022

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

Abbie Jemmott

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(412) 386-6433

C. E-MAIL ADDRESS

ygf3@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM X I CONTRACT CLAUSES

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

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

X D PACKAGING AND MARKING PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE X K OTHER STATEMENTS OF OFFERORS

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

X H SPECIAL CONTRACT REQUIREMENTS X M EVALUATION FACTORS FOR AWARD

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 436 25. PAYMENT WILL BE MADE BY CODE 434 Centers for Disease Control and Prevention (CDC),(OAS) 626 Cochrans Mill Rd Pittsburgh, PA 15236-0070

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) Abbie Jemmaott

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

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Reusable Elastomeric Respirators in Healthcare Settings - Assessment, Best Practices and Preferred Uses

Period of Performance:

42 months from Award

1 Each

The Government intends to award between 1 and 3 contracts as a result of this solicitation.

HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A— Health Resources Priorities and Allocations System.

B.1 TYPE OF CONTRACT

This contract is a Firm Fixed Price as defined in Federal Acquisition Regulation (FAR) section 16.202.

B.2 PERFORMANCE OF INHERENTLY GOVERNMENTAL, CRITICAL, OR OTHER FUNCTIONS

The services contemplated under this contract are considered to be an Other Function as defined by the Office of Federal Procurement Policy in OFPP letter 11-01 and by HHS in Acquisition Policy Memorandum 2012-01.

B.3 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

Funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)

RFP 75D30122 R72138

SECTION C- STATEMENT OF WORK Rev 07

Reusable Elastomeric Respirators in Healthcare Settings - Assessment, Best Practices and Preferred Uses

Section 1: Background

The National Personal Protective Technology Laboratory (NPPTL) of The National Institute for Occupational Safety and Health (NIOSH) conducts personal protective equipment (PPE) research and evaluations on respirators, gloves, surgical gowns, etc. The “best or preferred use practice” is for conventional Elastomeric Half Mask Respirators (EHMR), and a new prototype Reusable Healthcare Elastomeric Respirator (RHER) use in healthcare settings by Healthcare Providers (HCP) of multiple occupations.

The Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH) need to better understand whether, and in what settings, elastomeric respirator use is preferred in the context of patient care, especially during public health emergencies when there is an urgent need and demand for effective respiratory protection. The use of a reusable elastomeric respirator in healthcare could serve as an alternative to disposable N95 grade Filtering Facepiece Respirators (N95FFR), reducing the risk of shortages during outbreaks and pandemics. Ongoing research is assessing the feasibility of a healthcare system to rapidly fit-test, educate, and train HCP to wear and maintain reusable elastomeric respirators during a simulated public health emergency. This research is also assessing the experiences of a healthcare system to incorporate reusable elastomeric respirators into routine healthcare delivery to better understand their feasibility for HCP protection and patient care. It is essential to define best or preferred practices for using EHMRs in delivering effective healthcare. The need to acquire data to assess concerns of HCP protection, patient care procedures, and Elastomeric Respirator advantages and challenges of selection, use, and maintenance. Guidance needs to be produced defining best practices for the preferred selection, use, and maintenance of Elastomeric Respirators in practical healthcare applications.

Elastomeric Respirators provide at least the same level of protection as N95FFRs, are tight-fitting, use replaceable filters, cartridges, or canisters, and have facepieces made of synthetic or natural rubber material permitting repeated cleaning, disinfection, storage, and reuse. Elastomeric Respirators are being more widely used in U.S. healthcare delivery during the COVID-19 response, to an extent that far exceeds routine use and experience prior to the pandemic. The COVID-19 experience can serve as a basis to incorporate reusable respirators into the national stockpiling strategy for the future large-scale infectious outbreaks and pandemics (including additional waves of

COVID-19).

Respirator manufacturers have introduced new designs and accessories since the COVID-19 pandemic started and NIOSH respirator designs in prototype stages are available for evaluation by HCP

To date, only a few hospitals in the U.S. use elastomeric respirators as part of their daily, routine care. Elastomeric respirators are not typically used in healthcare, in part, because of upfront costs required by hospitals, workers are unfamiliar with them, and there is uncertainty about the disinfection methods. The Centers for Disease Control and Prevention (CDC) is addressing these issues through a three-phase, multi-site study in which elastomeric respirators are being examined in three adult hospitals with respect to: (1) rapid fit testing and training of elastomeric respirators;

(2) testing effective elastomeric respirator disinfection processes and workers’ ability carry out these processes; and

(3) testing the feasibility of conducting patient care while wearing elastomeric respirators (pending).

Expansion of these studies into a similar study that will examine and compare a variety of elastomeric respirators in a healthcare setting is needed to fully understand how healthcare workers interact with and use EHMRs. Additionally, a full assessment of strengths and limitations of a variety of EHMRs currently on the market is needed and will be provided via this effort.

Section 2: Objectives

There are multiple objectives for this initiative that involve the study and assessment of Elastomeric Respirator selection, use, and maintenance practices in healthcare facilities. The main objectives are as follows:

1. In a healthcare setting, evaluate and compare commercially available elastomeric respirators with and without exhalation valves and exhalation valve filter adapters. Further, NIOSH developed prototypes of a reusable respirator specifically for HCPs and prototypes of exhaled breath filter adaptors for select commercial respirators will be evaluated. Respirator models will be chosen subject to availability and NIOSH determination

2. Examination of HCP perspectives and concerns regarding EHMR use in a healthcare setting. These should include, but are not limited to an assessment of comfort, practicability, and compatibility with other PPE

3. Examination of criteria needed to adopt elastomeric respirators in a healthcare setting including new educational requirements, adult & pediatric patient assessments, respirator fit capability, and an analysis of reusable filtration products.

4. Determine the effect of EHMRs on simulated workplace activities by physiological measurements including transcutaneous carbon dioxide (TcCO2), oxygen saturation (SpO2), respiratory rate, inspired temperature, and moisture content.

Section 3: Statement of Work

The statement of work will be tasks surrounding elastomeric usage in a healthcare setting. There are options for six

(6) groups of respirator configurations to be evaluated as given in the table below. A healthcare organization can choose to bid and perform the study on one or more respirator groups. In each group, the respirator configurations will be evaluated independently by a different team of HCPs. Studies would require an Institutional Review Board (IRB) approval from the healthcare organization’s approving authority. These studies may also require an Office of Management and Budget (OMB) Paperwork Reduction Act (PRA) determination prior to conducting surveys required in the study. The OMB determination application will be actioned by NIOSH. One of the firsts tasks to be completed is finalize the surveys, and any other data collection tools, for submission by NIOSH to OMB to allow time for approval needed to begin data collection. The IRB approval must be obtained by the organization and the OMB PRA determination must be in place prior to any studies with human subjects. Contracts may be awarded to multiple study sites and the period of performance is expected to be about one year for OMB determination and two years for study execution. No human subject data may be collected until OMB approval is obtained.

3.1 Healthcare Setting: The study will be conducted in a hospital setting affiliated with a University in the United States. All aspects of the study will be managed and executed in the United States.

3.2 HCP subject populations: The total study population for each group is listed in the table below. HCPs in different job functions should be used in execution of this study. These should include all HCP who have direct patient care responsibilities as well as hospital staff who are included in a hospital respiratory protection program but do not have direct patient care responsibilities, for example: janitorial staff, cafeteria staff, or environmental services staff. It is also critical that at least 15% of HCPs enrolled in the study are involved in pediatric care. Each HCP may only participate in the study one time. HCP subjects will be enrolled in the study and use the respirators for 3 months.

Based on data from previous hospital respirator studies, the study population should be 15-25% male.

3.3 Respirators: The respirators used in the study will be Elastomeric Half-Mask Respirator (EHMR) designs that can be disinfected and reused. Subject to availability, and at NIOSH’s discretion, a range of respirators and respirator exhalation valve adapters will be used in the study that is split into six groups. The respirators used in the study may be NIOSH certified commercially available respirators, commercially developed new respirators that are close to production quality and NIOSH prototypes. Where available exhalation valve adapters for source control will be used. Through current development projects at NIOSH, prototypes of Exhaled Breath Filter Adaptors (EBFA) for select commercial respirators and a Reusable Healthcare Elastomeric Respirator (RHER) with features desired by healthcare workers will be available for this study. HCPs in the relevant group that includes the RHER prototype will have the opportunity to give input on its features to finalize the design. All the NIOSH prototypes will be tested to the breathing performance standards applicable to the class of respirator before they are used in human subject testing.

If a hospital is already using a specific model elastomeric respirator in their respiratory protection program, they will not be considered for the group that primarily uses that respirator. For example, if a hospital regularly uses the MSA 200 respirator in their respiratory protection program, they would not be considered for group 3.

Respirator Group

Minimum # Subjects Manufacturer

Respirator model Exhalation Valve Adapter Filter

1 100

3M 6200 none P100

3M 6200 NIOSH EBFA-1 P100

3M 6200 3M adapter P100

NPPTL RHER

2 100

3M 7500 none P100

3M 7500 NIOSH EBFA-2 P100

3M 7500 3M adapter P100

NPPTL RHER

3 100

MSA 200 LS none P100

MSA 290 LS no exhalation valve P100

MSA 200 LS NIOSH EBFA-4 P100

NPPTL RHER

4 75

Honeywell RU8500 none P100

Honeywell RU8500 NIOSH EBFA-3 P100

NPPTL RHER

5 Up to 125

Group of up to five (5) elastomeric respirator models selected by NPPTL. This group will consist of respirator models with no exhalation valve ports or that are designed be blocked. The total number of subjects will remain the same to evaluate the respirators in this group

6 125-250

Group of five (5) to ten (10) elastomeric respirators models selected by NPPTL. This group may include some or all respirator models in the other groups and new models. The total number of subjects will remain the same to evaluate the respirators in this group

3.4 – NIOSH prototype - Reusable Healthcare Elastomeric Respirator (RHER) - conceptual prototype feature evaluation Conceptual prototypes of the Reusable Healthcare Elastomeric Respirator (RHER) that meets the specific requirements of the healthcare worker were designed and built by NIOSH through a separate contract. The RHER is ergonomically designed to be donned quickly, be low profile and to allow for improved downward vision. It is designed to be non-threatening to benefit the patient experience, have splash guards, deflect the exhaled breath rearward, easy to dismantle for cleaning/disinfecting, and packable for storing in a small space. This conceptual design needs to be refined and elevated into a prototype that can be used in this study. For this purpose, the final features to be incorporated into a prototype need to be determined by examining the conceptual prototype that was developed.

RHER feature evaluation and prioritizing will be achieved through input from at least 10 HCP through structured consultations and using design tools such as ‘House of Quality’ (HoQ) to identify important features. NIOSH will guide the feature evaluation.

3.5 – NIOSH prototype - Exhaled Breath Filter Adaptors (EBFA) for select commercial respirators EBFAs will be designed to fit onto the respective respirator encasing the exhalation valve assembly, sealing it from the ambient air and incorporate features to accommodate single sheet or multi-layer filter media. The adaptors serve to divert and filter the exhaled breath, directing it downward and/or rearward, passing it through filter media before exiting the adaptor. Four EBFAs are being designed and built by NIOSH through a separate contract. Each of the four adaptors will be custom designed to fit commercially available respirators as listed below.

1. EBFA-1 for 3M 6200 respirator with 7093 P100 cartridges

2. EBFA-2 for 3M 7500 respirator with P100 cartridges

3. EBFA-3 for Honeywell RU8500 respirator with P100 filter cartridges and cover

4. EBFA-4 for MSA Advantage 200 LS respirator with low profile P100 cartridges

Section 4. Tasking: For each group selection, the following tasks will be completed:

4.Task 1: HCP Survey Tools All survey tools will be developed by NIOSH. Each study location will be able to add additional questions to the surveys but will not be able to remove questions from the NIOSH surveys. Each site will send their final versions of the survey documents to NIOSH and NIOSH will submit for to OMB for PRA approval.

4.Task 2: IRB Approval Each site will be responsible for obtaining IRB approval prior to any data collection begins. Final IRB approval documentation will be submitted to NIOSH.

4.Task 3: RHER feature evaluation The RHER prototype is being designed for use with replaceable P100 or N95 filter elements and will undergo the same rigorous testing given to other NIOSH approved respirators to ensure it meets standards in place for safety and efficacy. NIOSH will guide the RHER feature evaluation.

1. Examine conceptual RHER’s features and identify any new features to be considered in the RHER design through structured consultations with HCP researchers experienced in the use of EHMRs. Compile list of features to be considered in the RHER design.

2. Apply the ‘House of Quality’ (HoQ) tool to prioritize important features identified. Input is required from at least 10 HCPs experienced in the use of EHMRs. Submit a report on feature evaluations and feature priority with HoQ spreadsheets of individual and group summaries

4.Task 4: How comfortable is the respirator?

Hospital study sites will monitor healthcare workers in a simulated healthcare setting to assess the physiologic effect wearing the designated respirator has on the worker. At a minimum the following parameters will be assessed:

- Tc CO2 in blood gas via transcutaneous measurement and in mask sample (inspired breath)

- SpO2 in blood gas via transcutaneous measurement and in mask sample (inspired breath)

- Temperature measured via a thermocouple or thermistor inside respirator and/or on subject’s face

- Subject body temperature measured at minimum before and after each EHMR use

- Assessment of moisture buildup

- Qualitative assessment of ease of breathing

- Measurement of respiration rate

- Measurement of heart rate

- Any other physiological parameter of interest to study hospital

Comfort assessment will be collected once from a minimum of 25 subjects for each model respirator tested.

Submission of a summary report on study variables for each respirator within the option for all subjects will indicate the completion of this task. Similarities and differences between and among respirator configurations should be documented.

4.Task 5: How practical is the respirator?

Hospital study sites will recruit and have HCP exclusively use the EHMRs for a minimum of 3 months. During these 3 months, the HCP participants will be surveyed to identify how practical the respirator is to use in a healthcare setting.

HCP participants will complete 3 surveys throughout the study period – at the beginning of the study, in the middle of the study, and at the completion of the study period. Survey tools will be developed by NIOSH and will include, at a minimum, questions to identify:

- How easy is the respirator to clean?

- How easy is the respirator to disinfect?

- Speech Intelligibility - How easy is it to communicate with coworkers and patients in the respirator?

- How easy is the respirator to assemble and disassemble?

- How easy is the respirator to don/doff?

- How long per shift do workers wear respirator (all shift without removing, or donning/doffing/disinfecting for every patient encounter)

- What is the range of vision while wearing the respirator? Is it impacted?

- Is there any interference with other PPE?

- Is there any interference with other clothing or hairstyles that you wear?

- Additional EHMR practicality variables of interest to hospital

Data collection for the study will be considered complete when all subject records – consisting of a pre-, post-, and mid- point survey for each subject have been submitted to NIOSH. Pre-surveys will be administered at the beginning of a subject’s participation, mid-point surveys will be administered at 6 weeks into a subject’s participation +/- 1 week, and post-surveys will be administered after 3 months of participation, as a subject concludes their participation in the study. A minimum of 25 complete data sets for each respirator model must be submitted to NIOSH by the study’s completion for payment. Records that are not complete data sets must also be submitted to NIOSH by the study’s completion

A summary report of survey responses for each respirator within the option making note of respirator configuration similarities and differences will be prepared and submitted to NIOSH at completion of this task

4.Task 6: What is the respirator fit capability in the healthcare setting?

Researchers will capture information regarding the bizygomatic width and menton-sellion length of each HCP’s face using spreading and sliding calipers, respectively. The NIOSH bivariate panel will be used to identify the distribution of faces and the respirator fit capability will be assessed for each respirator within the designated option. Sites should report the make, model, and size respirator subjects normally wear, and which EHMR size respirator they fit into.

Respirator fit capability will be reported to NIOSH following fit testing of the respirators. A reference document for how to measure the bizygomatic width and menton-sellion length is included in the Appendix.

Respirator fit capability data from all subjects enrolled in the study for each model respirator tested will be reported to NIOSH at completion of this task.

4.Task 7: Patient Assessment in adult and pediatric patient populations A survey tool will be developed by NIOSH to assess adult and pediatric patient perception of each respirator model.

It is critical that healthcare workers who predominantly work with pediatric patients be included in the study.

Differences between pediatric responses and adult patient responses to the respirator will be documented and reported in a summary report.

A single survey will be issued to at least 25 patients (15% of which should be pediatric patients or their caregivers) for each respirator configuration. Results from the survey will be compiled in a report sent to NIOSH indicating the completion of this task.

4.Task 8: Used Filter Testing

At the completion of the study, all respirator filters will be mailed to NIOSH NPPTL for further evaluation. NIOSH will conduct a laboratory analysis on filter loading and wear to determine recommended change out schedules for filters used in respirators in healthcare settings. Hospital study sites will log the use schedule (days and hours worn) of the filters used throughout the study and how many times the filter elements were disinfected.

Section 5: Document review, clearing and data rights

No information related to data obtained under this contract shall be released or publicized without the prior consent of NIOSH.

NIOSH will review and give comments on any documents and webinars to the hospital study site. This would be for the initial and subsequent submissions until finally approved by NIOSH. It is anticipated that webinars will be 30-60 minutes in length but may be longer if multiple tasks are combined. All documents to be published and webinars to be presented need to undergo the NIOSH clearing process that typically takes about 2 months. NIOSH will coordinate the webinars.

Each contract will produce a minimum of two published peer-reviewed manuscripts on which NIOSH will be co-authors. NIOSH should be informed of all published outputs (e.g. manuscripts, webinars, conference presentations, conference posters, etc.) and at NIOSH’s discretion will elect to be co-authors on any additional outputs.

All publications including conference abstracts and webinars resulting from this study will only be allowed to be submitted after a final report for the task has been received and approved by NIOSH.

Data rights and publicizing are part of the contract that includes this Statement of Work and clauses detailing these are given in the contract document.

Section 6: Deliverables

6.1 General Deliverables:

Project Plan- A project plan will be developed outlining the tasks to be completed, timeline and agreed with the program office. A Gantt chart should be included in the project plan. A template is provided in the appendix to assist in developing and presenting the project plan.

Kick-Off Meeting- A project kick-off meeting will be held by tele/ video conference to review the Project Plan and ensure that all stake holders agree on the program execution. The contractor’s and NIOSH’s personnel associated with the project will be introduced.

Monthly Reports- in narrative form containing technical results of the work accomplished during the reporting period. Updates on the status of delivery schedules should be included when applicable. This report shall be in enough detail to disclose all work started and results achieved during the reporting period, an indication of any current problems which may impede performance, the proposed corrective action, and the work forecast for the next period. Any changes or delays anticipated to previously established schedules should be reported. This document shall report progress and planning to correspond with the work schedule contained in the approved program plan. A template is provided in the appendix to assist in presenting the monthly report. Monthly reports are due on the 1st of every month after the contract has been signed by all institutions.

A meeting will be convened to discuss the monthly report at NIOSH’s discretion.

Final Report- in narrative form containing technical results of the work accomplished during the contract period.

This report shall be in enough detail to disclose all work and results achieved during the contract period, any problems which impeded performance and any corrective actions taken. Any issues encountered and corrective action taken during the execution of the tasks should be noted. Any changes or delays experienced to originally established schedules should be mentioned. The Statement of Work (SoW) and Project Plan (PP) should be referenced when appropriate. Appendices should be used for equipment technical details, specifications, schematics, data collection and analysis protocols. A template is provided in the appendix to assist in presenting the final report.

Publications- All publications including conference abstracts and webinars resulting from this study will only be allowed to be submitted after a final report for the task has been received and approved by NIOSH.

6.2 Information Exchange with NIOSH

Information transferred between contractor and NIOSH may be sensitive and its confidentiality, integrity, and/or availability may need to be protected. The Contractor (and/or any subcontractor) shall protect all government information and utilize SFTP and/or SAMS as a file-sharing method between NIOSH and the Contractor for any reports, protocols and other documents as needed. General communication would be via email and video conference portals.

6.3 Specific Deliverables Means of Delivery

Due Date from contract award

Project Plan Use template provided in the contract

MSWord document and pdf document and Excel spreadsheet

Within 3 weeks after contract signing

Kick-Off Meeting online conference Within one month after contract signing

Monthly Report Use template provided in the contract

MSWord document and pdf document

Monthly

4. Task 1 Final surveys for OMB approval. NIOSH will provide the minimum survey questions and each site will provide final versions for their specific site with any additional questions they want to add, added. NIOSH will submit the final surveys to OMB for PRA approval

MSWord document and pdf document

Within three (3) months after kick-off meeting

4. Task 2 IRB approval - Each site will obtain IRB approval at their institution and send approval letter to NIOSH

MSWord document and pdf document

Within five (5) months after kick-off meeting

4.Task 3 Examine conceptual RHER’s features and identify any new features to be considered in the RHER design. Compile list of features to be considered and prioritize important features using the HoQ tool.

Report on feature evaluations and feature priority with HoQ spreadsheets of individual and group summaries

MSWord document and pdf document / Excel spreadsheet

Within two (2) months after the kick-off meeting

4.Task 4 Monitor healthcare workers in a simulated healthcare delivery setting to assess the physiologic effects.

Summary report on study variables for each respirator within group. Similarities and differences between respirator configurations should be documented.

MSWord document and pdf document

Within Nine (9) months after OMB approval

4.Task 5 Survey the HCP participants to identify how practical the respirator is to use in a healthcare setting. The survey tool will be developed by NIOSH.

Report on summary of survey responses for each respirator within the group making note of respirator configuration similarities and differences

Online survey database (e.g. REDCap) MSWord document and pdf document

Within Twenty Four

(24) months after OMB approval

4.Task 6 Capture information regarding the bizygomatic width and menton-sellion length of each HCP’s face referencing the NIOSH bivariate panel

Respirator fit capability report following fit testing of the respirators.

Online survey database (e.g. REDCap) MSWord document and pdf document / Excel spreadsheet

Within Twenty (20) months after OMB approval

Section 7: Government Furnished Materials

NIOSH will provide the following:

1. Guidance on developing project plans, submitting monthly reports, and final report

2. RHER feature evaluation guidance using design tools such as ‘House of Quality’ (HoQ)

3. NIOSH developed prototype respirators, filters and exhaled breath filter adaptors.

4. Commercially available respirators, filters, and accessories

5. Survey(s) needed to conduct the assessments as applicable.

Section 8: Period of Performance

The period of performance will be three and a half years (3 years, 6 months) from the date of award of the contract(s)

Section 9: Place of Performance

Services will be performed at the Hospital study sites and their sub-contractor’s facilities. All aspects of the study will be managed and executed in the United States

4.Task 7 NIOSH will develop survey tools to assess patient perception of each respirator model in adult and pediatric healthcare settings.

Conduct study with enrolled participants using the survey developed.

Summary report on pediatric and adult patient responses

MSWord document and pdf document

Within Twelve (12) months after OMB approval

4.Task 8 Log the days and hours the filters were used throughout the study and intervals the filter elements were disinfected.

All used filters elements individually packaged and marked with use time and interval log will be sent back to NIOSH for testing.

Used filter elements and MSWord document and pdf document

At completion of contract

4. Task 9 Final Report Containing results of the work accomplished during the contract period. This report shall be in enough detail to disclose all work completed including project objectives methods used, results achieved, discussions of the results, conclusions drawn and recommendations for future work.

Use template provided in the contract

MSWord document and pdf document

At completion of study

4. Task 10 Produce a minimum of two published peer-reviewed manuscripts based on data collected in Task 4 through Task 8 on which NIOSH will be co-authors. NIOSH should be informed of all published outputs and at NIOSH’s discretion will elect to be co-authors on any additional outputs.

Manuscripts will be published after receipt and acceptance of the final report

MSWord document during review and pdf document or other format required by the publishers for the final manuscript

After acceptance of Final Report by

NIOSH-NPPTL

SECTION D - PACKAGING AND MARKING

There are no clauses/provisions included in this section.

SECTION E - INSPECTION AND ACCEPTANCE

E.1 CLAUSES INCORPORATED BY REFERENCE

FAR SOURCE TITLE AND DATE

52.246-1 Contractor Inspection Requirements (Apr 1984) 52.246-4 Inspection of Services - Fixed-Price (Aug 1996) 52.246-16 Responsibility for Supplies (Apr 1984)

E.2 INSPECTION AND ACCEPTANCE (JUL 1999)

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) at the destination of the articles, services or documentation.

(End of Clause)

SECTION F - DELIVERIES OR PERFORMANCE

52.242-15 Stop-Work Order, Alternate I (Aug 1989)

F.1 PERIOD OF PERFORMANCE

The period of performance for this contract is 42 months from Award.

F.2 DELIVERABLE DOCUMENTATION

Please see Section 6 of the Statement of Work.

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 CDCP.G009 - CONTRACTING OFFICER (JUL 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.2 CDC0.G008 –CONTRACTING OFFICER’S REPRESENTATIVE (COR) (JUL 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 CDCO.G018 - PAYMENT BY ELECTRONIC FUNDS TRANSFER (FEB 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 and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: 404-638-5342

(End of Clause)

G.4 CDCP.G010 - CONTRACT COMMUNICATIONS/CORRESPONDENCE (JUL 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.

(End of Clause)

G.5 CDC37.0001 - NON-PERSONAL SERVICES (APR 2013)

(a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled “Identification of Contractors' Employees and Safeguarding Government Information.” No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract.

All contract changes will be incorporated by a modification signed by the Contracting Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the substance of this clause. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of this clause shall be included in all subcontracts at any tier.

(d) Nothing in this clause shall limit the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

(End of Clause)

G.6 CDC42.0002 - EVALUATION OF CONTRACTOR PERFORMANCE UTILIZING CPARS (APRIL

2013)

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.

Contractor to provide CPARS representative contact information:

Name:

Title:

Email Address:

Phone Number:

(End of Clause)

G.7 CDCA_G001 – INVOICE SUBMISSION (MAR 2021)

(a) The Contractor shall submit the original contract invoice/voucher in one of the following ways: 1) mail, 2) facsimile, 3) email:

Mailing Address:

The Centers for Disease Control and Prevention

Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333

Fax: 404-638-5324

Email: cpbapinv@cdc.gov

NOTE: Submit only one Invoice in PDF format per attachment.

(b) Subject Line must contain the word “Invoice” Example: Subject: Invoice SAM12345 for Contract 75D30122 ******

(c) The content/details of the email must include the below information provided in the body of the email:

Contract or PO Number:

Invoice Number:

Amount:

Vendor Name:

Only one invoice can be sent to the mailbox with the above relevant details in the body (multiple invoices need to be sent in multiple emails)

(d) The contractor shall submit 2 copies of the invoice to the cognizant contracting office previously identified in this contract. These invoice copies shall be addressed to the attention of the Contracting Officer.

(e) Do not send Links, Zip Files, or .DAT files containing PDF Invoices

(f) The Contractor is X , is not required to submit a copy of each invoice directly to the Contracting Officer’s Representative (COR) concurrently with submission to the Contracting Officer.

(g) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Office of Financial Resources is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(h) 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, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number 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

(14) Electronic funds transfer (EFT) banking info

For the status of invoices, please contact the OFR Service desk at ofrservicedesk@cdc.gov

NOTE: If your invoice has supporting documents, please combine the invoice and supporting documents as one PDF file. Do not submit the invoice and its supporting documents separately.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 CDCA.H003 - DISSEMINATION OF INFORMATION (MAY 1998)

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR.

(End of Clause)

H.2 CDCA.H004 - IDENTIFICATION OF DATA (MAY 1998)

The Contractor shall identify the technical data delivered to the Government as required by this contract with the number of the contract and the name and address of the Contractor or subcontractor that generated the data.

(End of Clause)

H.3 CDCA.H034 – RETENTION OF CONTRACTOR RECORDS (JAN 2000)

The contractor agrees to maintain an accounting system that will keep accurate, complete, and current accounting of all financial transactions on a site specific basis under the contract. The contractor shall retain for a period of not less than ten (10) years after final payment under this contract, those pertinent accounting records and supporting documentation related to ATSDR cost recovery Superfund records, in accordance with the EPA Superfund Financial Management and Record Keeping, Guidance for Federal Agencies, dated January 1989. The contractor shall obtain written authorization from the Contracting Officer prior to the disposal of such records.

The contractor agrees to include this provision in all subcontracts awarded under this contract.

(End of Clause)

H.4 TOBACCO-FREE CAMPUS POLICY (2013)

In compliance with Department of Health and Human Services (DHHS) regulations, all contractor personnel performing work within CDC/ATSDR facilities shall observe the CDC/ATSDR Tobacco-Free Campus Policy at all times. Effective March 5th, 2018, the use of tobacco products (including cigarettes, cigars, pipes, smokeless tobacco, other tobacco products, or e-cigarettes) is prohibited at all times on the NIOSH Pittsburgh facility.

(End of Clause)

H.3 352.239-73 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY (DEC 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508…