Elastomeric_SOW_-_Revised_5-9-18.pdf

Statement of Work

Title: Assessment of elastomeric respirators in healthcare delivery settings

SECTION 1 – BACKGROUND

The demand for the respiratory protective devices (RPD) worn by U.S. healthcare personnel (HCP) during a large respiratory infectious disease outbreak, such as an influenza pandemic, is expected to far exceed domestic supplies. Approximately 3.6 billion disposable and 1.6 million reusable respirators may be needed. A rapid increase in RPD usage was apparent during the 2009 H1N1 influenza pandemic and the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS). During these events, HCP reported that N95 filtering facepiece respirators were not readily available in some locations due to exhaustion of available supplies, inability of suppliers and manufacturers to meet the surge in demand, and shortages of fit testing equipment.

The U.S. Department of Health and Human Services recommends that healthcare facilities stockpile a six to eight-week supply of disposable N95s, however achieving this recommendation has been a challenge for many due to financial limitations. In 2012, the Association of State and Territorial Health Officials estimated that U.S. acute care hospitals have 60 million N95 respirators on hand, two orders of magnitude smaller than the estimated demand during a severe influenza pandemic. This underscores the importance of including RPD in the Strategic National Stockpile maintained by the Centers for Disease Control and Prevention (CDC).

Wider utilization of reusable elastomeric respirators, which can be cleaned and repeatedly worn, are being considered as one way to mitigate shortages of disposable N95 respirators during public health emergencies. The Veterans Health Administration recently stockpiled elastomeric respirators for use during a surge in demand for N95 respirators. The National Academy of Medicine, Centers for Disease Control and Prevention, and Food and Drug Administration have recently held stakeholder meetings to assess, in part, the potential future role of elastomeric respirators in healthcare delivery. In 2013, Worksafe British Columbia issued a report about the use of elastomeric respirators during a surge in demand. In 2009, the University of Maryland Medical System began fitting HCP with elastomeric respirators to wear during patient care. Another study by the Veterans Health Administration determined that stockpiling elastomeric respirators, in addition to other types of respiratory protection, may result in considerable cost savings.

However, reusable elastomeric respirators are infrequently used in U.S. healthcare delivery, so most HCP have little or no experience with them. CDC and the National Institute for Occupational Safety and Health (NIOSH) need to better understand whether and in what settings elastomeric respirators could be used in the context of patient care, especially during public health emergencies when there is an increase in demand for N95s and other RPD.

SECTION 2 – PURPOSE

The purpose of this initiative is to determine the feasibility and capability of U.S. healthcare delivery organizations to routinely use reusable respirators and/or rapidly convert to their use during a public health emergency. A competitive contract funding mechanism will identify and select up to three U.S.

healthcare delivery organizations as partners for a series of demonstration projects and clinical studies.

SECTION 3 – SCOPE OF WORK

This Statement of Work includes a Base Contract and two Options. Offerors may submit a proposal for

(1) the Base Contract, (2) the Base Contract and Option A, (3) the Base Contract and Option B, or (4) the Base Contract, Option A, and Option B.

Base Contract: The base contract demonstration project will assess the feasibility of a healthcare system to rapidly fit-test, educate, and train between 50 and 100 HCP to wear and maintain reusable elastomeric respirators during a simulated public health emergency. The contractor should conduct the ‘just in time” fit testing as quickly as possible, taking no longer than one week and shall be completed in the single location in order to standardize the process and minimize the variability for the research protocol. NIOSH will provide for this contract (a) a draft study protocol, (b) draft education and training materials, and (c) draft metrics to evaluate the effectiveness of the training and education materials. It is expected that the contractor will spend 100 hours adapting the materials to use during this demonstration project.

A report, including qualitative and quantitative data, on this demonstration project will be prepared by the awardee. The report will include (a) a review and analysis of what was required to complete the fit testing, education, and training activities, (b) the aggregate results of the evaluation metrics, and (c) observations reported by health system leadership about the feasibility of elastomeric use before, during, and after the demonstration period.

Option A: The first optional demonstration project will assess the experiences of a healthcare system incorporating reusable elastomeric respirators into routine healthcare delivery to better understand their feasibility for patient care. This demonstration project is to be conducted in a setting where HCP routinely wear respiratory protection, such as locations where patients with known or suspected tuberculosis infection are housed. This demonstration project could occur in several patient care areas, although it is expected that a single health system will be used.

A report, including quantitative data, on this demonstration project will be prepared. The report will include (a) the results of knowledge and experiential surveys administered to HCP participants, and (b) observations reported by health system leadership about the feasibility of elastomeric use before, during, and after the demonstration period. Due to the requirements of this demonstration project, approval from the Office of Management and Budget will be required. NIOSH staff will assist with the preparation of materials related to submission of the survey tools.

Option B: The second optional demonstration project will assess and compare two different methods of elastomeric respirator disinfection based on published literature (and research underway to be published in forthcoming literature) to determine best practices. The best practices will be used to define a standard operating procedure. This demonstration project is to be conducted in a setting where HCP routinely wear respiratory protection, such as locations where patients with known or suspected tuberculosis infection are housed. This demonstration project could occur in several patient care areas, although it is expected that a single health system will be used.

A report, including quantitative data, on this demonstration project will be prepared. The report will include (a) observations reported by the healthcare system leadership about the feasibility of disinfection before, during, and after the demonstration period, and (b) a side-by-side comparison of the disinfection effectiveness (using quantitative outcomes) of different disinfection methods.

NIOSH staff at the National Personal Protective Technology Laboratory (NPPTL) will develop materials and processes related to fit-testing, education and training and a draft protocol for the Base Contract.

If multiple contracts are awarded, NIOSH will work with each contractor to ensure consistency in gathering the data through the protocol submitted to each contractor’s Institutional Review Board

(IRB).

To facilitate the implementation of the base contract, NIOSH will provide to the contractor an instructional video and mock tabletop exercise demonstrating how to fit test, educate, and train HCP for elastomeric respirator use.

Except for the materials specifically mentioned in this Statement of Work to be provided by CDC/NIOSH, the Contractor shall furnish all labor, equipment, materials, and supplies necessary to perform the tasks that follow.

SECTION 4 –TASKS TO BE PERFORMED

BASE CONTRACT - TASKS TO BE PERFORMED

Task - Base 0: Development of a Project Plan Develop a project plan to complete the demonstration project, detailing the steps and activities required to successfully accomplish the seven Tasks as defined below. The plan shall be submitted to the COR for review and approval at least two (2) weeks before implementation.

Task - Base 1: Adapting the Draft NIOSH Protocol Adapt the NIOSH Draft IRB protocol describing the steps needed to conduct the fit testing for approval at contractor’s institution. The adapted IRB protocol shall be submitted to the COR for review and approval at least two (2) weeks before the adapted protocol is submitted to the contractor’s IRB. The final IRB-approved protocol shall be submitted to the COR within two (2) weeks of IRB-approval.

Task - Base 2: Adapting the Draft Educational Materials Adapt the NIOSH-provided education materials provided by NIOSH for the trainers and the participants involved in the rapid fit-test simulation. These materials will consist of a PowerPoint presentation and handouts. The adapted education materials shall be submitted to the COR for review and approval at least two (2) weeks before the adapted materials are distributed for use.

Task – Base 3: Feasibility Assessment Assess the feasibility to rapidly fit-test, train and educate between 50 and 100 HCP to wear reusable elastomeric respirators during a simulated public health emergency. Develop a report describing the outcome of the assessment and identify any steps healthcare organizations should take to maximize the potential for successfully implementing an elastomeric respirator protection program in their organization. The report also shall analyze what was required to complete the fit testing, education, and training activities, including the amount of time required for each. Describe individual time and resource investment, by department, and provide recommendations for generalizing the training program during an emergency response scenario.

Task – Base 4: Effectiveness assessment of the training and education materials Assess the effectiveness of the training and education materials, including a description of capability of HCP to correctly use elastomeric respirators after receiving standardized instructions. Describe the aggregate results in a report including correctly donning, doffing, cleaning and disinfecting the respirators.

Task – Base 5: Observations Document the observations of healthcare system leadership about the feasibility of elastomeric use before, during, and after the demonstration period. The observations shall be detailed in the contractor’s Final Report.

Task – Base 6: Webinar Develop and provide a free webinar to the general public presenting the findings described in Final Report. NIOSH will coordinate the webinar. It is anticipated that the webinar will be 30-60 minutes in length. The webinar shall be submitted to the COR for review and approval at least two (2) weeks before release to the general public.

OPTION A - TASKS TO BE PERFORMED

Task – Option A 0: Development of a Project Plan required to successfully accomplish the five Tasks as defined below. The plan shall be submitted to the COR for review and approval at least two (2) weeks before implementation.

Task – Option A 1: Protocol Development Develop a protocol commensurate with the requirements of the contractor’s IRB describing the steps needed to assess the experiences of a healthcare system including a minimum of 25 staff members to incorporate reusable elastomeric respirators into routine healthcare delivery to better understand their feasibility for patient care. The IRB protocol shall be submitted to the COR for review and approval at least two (2) weeks before the protocol is submitted to the contractors’ IRB.

Task – Option A 2: Protocol Implementation Implement the protocol with a minimum of 25 staff members for a minimum of two months.

Task – Option A 3: Knowledge and Experience Assessment Assess the results of knowledge and experience of HCP participants. Describe the results of knowledge and experiential surveys administered to HCP participants in a report.

Task – Option A 4: Observations Document the observations of healthcare system leadership about the feasibility of elastomeric use before, during, and after the demonstration period. The observations shall be detailed in the contractor’s Final Report.

Task – Option A 5: Webinar Develop and provide a free webinar to the general public presenting the findings described in Final Report. NIOSH will coordinate the webinar. It is anticipated that the webinar will be 30-60

OPTION B – TASKS TO BE PERFORMED

Task Option B 0: Development of a Project Plan required to successfully accomplish the five Tasks as defined below. The plan shall be submitted to the COR for review and approval at least two (2) weeks before implementation.

Task Option B 1: Standard Operating Procedure Development Develop a standard operating procedure for using two different approaches to disinfect elastomeric respirators, referencing the respirator manufacturer’s instructions, and other pertinent published materials. The procedure shall be submitted to the COR for review and approval at least two (2) weeks before implementation.

Task Option B 2: Elastomeric Disinfection Assessment Assess and compare different methods of elastomeric disinfection to determine best practices.

Prepare a report comparing the methods and describing best practices. The report detailing the best practices shall be submitted to the COR for review and approval at least two (2) weeks before implementation.

Task Option B 3: Evaluate Disinfection Approaches Evaluate the effectiveness of the two disinfection approaches Over a two-month period, evaluate the effectiveness of using each of the two disinfection approaches described in the standard operating procedure. Describe in a report the aggregate results of the side-by-side comparison.

Task Option B 4: Knowledge and Experience Assessment Assess the results of knowledge and experience of HCP participants. Describe the results of knowledge and experiential surveys administered to HCP participants in a report.

Task Option B 5: Observations Document the observations of healthcare system leadership about the feasibility of elastomeric disinfection before, during, and after the demonstration period. The observations shall be detailed in the contractor’s Final Report.

Task Option B 6: Task – Webinar Develop and provide a free webinar to the general public presenting the findings described in Final Report. NIOSH will coordinate the webinar. It is anticipated that the webinar will be 30-60

REPORTING TASKS TO BE PERFORMED FOR THE BASE CONTRACT AND EACH OPTION

Task: Kick-off Meeting: Conduct within two weeks of contract award

Task: Quarterly Reports: Submit quarterly reports describing progress and issues.

The Contractor shall prepare and submit quarterly technical progress reports in narrative form which shall contain technical results of the work accomplished during the reporting period. This report shall be in sufficient 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 quarter. Any changes or delays anticipated to previously established schedules should be reported. This document shall report progress and planning so as to correspond with the work schedule and deliverable schedule.

The quarterly progress report is to be delivered one (1) week after the end of each quarter.

Task: Final Reports: Prepare a final report for the Base and each demonstration project, as applicable.

The Contractor shall prepare and submit a Final Report detailing all of the work accomplished under this effort. The Final Report shall document and summarize the entire contract and shall include recommendations and conclusions based on observations and the results obtained. The Final Report shall include sufficient detail to comprehensively explain the results achieved as well as best practices to implement moving forward. The report shall include an analysis of salient findings, a presentation of general conclusions, and any guidance or recommendations deemed pertinent for future consideration by NIOSH. The report shall be submitted to the Government at least two (2) weeks prior to end of the contract for review. The Government will notify the Contractor in writing of approval or of recommended changes to be made in the final copy. If the Government does not approve or recommend changes within two (2) weeks of receipt, the report shall be deemed approved.

Task: Published Manuscript: Draft, submit and revise through final journal submission at least one peer-reviewed manuscript for the base and each demonstration project to document the results, lessons learned, and considerations for further development. NIOSH will serve as a co-author on the manuscript in accordance with CDC authorship guidelines.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

NIOSH will provide to the contractor up to 210 elastomeric respirators to each contractor to facilitate the implementation of this contract.

NIOSH will provide at least one government computer to each successful contractor to facilitate the implementation of this contract.

NIOSH will provide to the contractor a “just-in-time” fit testing protocol, HCP education and training materials, including an instructional video, and a draft protocol for the base contract.

NIOSH will provide the Survey(s) needed to conduct the assessments for contract options A, and B if applicable. No surveys will be conducted for the Base Contract.

SECTION 6 – PERIOD OF PERFORMANCE

Period of performance will be for the Base Contract from 07/01/2018 to 06/30/2021.

Option A – Eighteen months from start of the option. May overlap with Base contract. Option B - Eighteen months from start of the option, which may overlap with Base Contract and/or Option A.

SECTION 7 – PLACE OF PERFORMANCE

Services will be performed at the awardee’s campus.

SECTION 8 – INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

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: [ ] Low [X] Moderate [ ] High Integrity: [ ] Low [X] Moderate [ ] High Availability: [X] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [X] 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 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ ] 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, re-using, 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;

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.

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 OpDiv-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 prior to performing any work on behalf of HHS.

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.

http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf

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.

12) Privacy Impact Assessment (PIA) – The Contractor shall assist the CDC Senior Official for Privacy

(SOP) or designee with conducting a PIA for the information system and/or information handled under this contract.

a. The Contractor shall assist the CDC SOP or designee with completing a PIA for the system or information within prior to performing any work on behalf of HHS in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002.

b. The Contractor shall assist the CDC SOP or designee in reviewing the PIA at least every year throughout the system development lifecycle (SDLC)/information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/OpDiv Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete CDC Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum.

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and CDC Implementation of the HHS Rules of Behavior for Use of HHS Information Technology

Resources.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual OpDiv Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by CDC Computer Security Incident Response Team (CSIRT) within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII”.

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send CDC approved notifications to affected individuals within 30 days.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the CDC Computer Security Incident Response Team (CSIRT) at 866-655-2245 and CSIRT@cdc.gov, COR, CO, OpDiv SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable CDC and HHS policy and procedures, NIST standards and guidelines, as well as US- CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable

Information, HHS and CDC incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation.

Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6C: Sensitive - High Risk [ ] Level 5C: Sensitive -Moderate Risk

Homeland Security Presidential Directive (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within 14 of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 14 of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

2) System Documentation. Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR and system ISSO within 14 days before an employee stops working under this contract.

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or CDC policies.

6) The Contractor (and/or any subcontractor) shall perform and document the actions identified in the CDC Contractor Employee Separation Checklist when an employee terminates work under this contract within 1 days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/CDC policies and shall not dispose of any records unless authorized by HHS/CDC.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/CDC policies.

SECTION 9 – DELIVERABLES/REPORTING SCHEDULE/PAYMENT SCHEDULE

The contractor shall provide the following deliverables to the Project Officer by the Due Dates given below.

All electronic files should be delivered in MS Word format and provided via e-mail.

Base Contract:

Task Means of

Delivery

Due Date Payment

Kickoff Meeting Telecon/Skype Within two weeks of date of contract award

N/A

Roster Roster Within 14 days of the effective date of this contract and prior to performing any work on behalf of HHS

N/A

Contractor Employee

Non-Disclosure

Agreement (NDA)

Contractor

Employee Non-

Disclosure

Agreement

(NDA)

Prior to performing any work on behalf of HHS

N/A

Privacy Threshold

Analysis (PTA)/ Privacy

Impact Assessment (PIA)

Assist in the completion of a PTA/PIA form

Within 7 days after contract award

N/A

Training Records Copy of training records for all mandatory training

Within thirty (30) days of contract award and annually thereafter or upon request

N/A

Rules of Behavior Signed ROB for all employees

Initiation of contract and at least annually thereafter

N/A

Background Investigation Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

N/A

Task - Base 0: Develop Project Plan

Email Within six weeks of contract award

N/A

Task - Base 1: Elastomeric Fit Test Protocol - Develop a protocol describing the steps needed to conduct the fit testing and perform the rapid fit-test simulation.

Email Within two months after start of contract

Task - Base 2: Adapt the education and training materials.

Email Within three months after

Task - Base 3: Assess the feasibility to rapidly fit-test, train and educate 50 to 100 HCP to wear reusable elastomeric respirators during a simulated public health emergency. Include documentation of the time required to complete the fit testing, education, and training process.

Prepare and deliver a report describing the time to complete the fit testing, education and training.

Email Within twelve months after

Task – Base 4: Assess the effectiveness of the training and education materials. Describe the aggregate results in a report.

Email Within fourteen months after

Task – Base 5: Provide a report of observations by health system leadership about feasibility of elastomeric use before, during, and after the demonstration period.

Email Within sixteen months after start of contract

N/A

Task – Base 6: Provide a free webinar to the general public presenting the findings described in final report. NIOSH will coordinate the webinar.

Skype/Adobe connects

Within seventeen months after start of contract

Task – Base 7: Draft, submit and revise through final journal submission at least one peer-reviewed manuscript for the base and each demonstration project to document the results, lessons learned and considerations for further development.

NIOSH will serve as a co-author on the manuscript in accordance with CDC authorship guidelines.

Email Draft within 16 months after

Quarterly Reports Email Within one (1) week after the end of each quarter

N/A

Final Report Email One (1) month prior to the end of the Base Period

Demonstration – Option A - Tasks to be performed

Means of

Delivery

Due Date Payment

Kick-off Meeting Phone/skype Within two weeks of task option A award

N/A

Roster Roster Within 14 days of the effective date of this contract and prior to performing any work on behalf of HHS

N/A

Contractor Employee Non-Disclosure Agreement (NDA)

Contractor

Employee Non-

Disclosure

Agreement

(NDA)

Prior to performing any work on behalf of HHS

N/A

Privacy Threshold Analysis (PTA)/ Privacy Impact Assessment (PIA)

Assist in the completion of a PTA/PIA form

Within 7 days after contract award

N/A

Training Records Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

N/A

Rules of Behavior Signed ROB for all employees

Initiation of contract and at least annually thereafter

N/A

Background Investigation Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

N/A

Task Option A0: Develop Project Plan

Email Within six weeks of contract

Task A1: Develop a protocol describing the steps needed to assess the experiences of a healthcare system including a minimum of 50 staff members to incorporate reusable elastomeric respirators into routine healthcare delivery to better understand their feasibility for patient care.

Allow NIOSH two weeks to review and approve the protocol.

Email Within three months of contract award

Task A2: Implement the protocol with a minimum of 25 staff members for a minimum of six months.

Provide NIOSH one week to observe

Within 12 months of contract award

Task A3: Assess the results of knowledge and experiential surveys administered to HCP participants. Provide a report on the findings of the surveys.

Email Within 14 months of contract

Task A4: Provide a report of observations by health system leadership about feasibility of elastomeric use before, during, and after the demonstration period.

Email Within 16 months after start of contract

Task A5: Provide a free webinar to the general public presenting the findings described in final report. NIOSH will coordinate the webinar.

Skype/Adobe connects

Within 17 months after start

Task A6: Draft, submit and revise through final journal submission at least one peer-reviewed manuscript for the base and each demonstration project to document the results, lessons learned and considerations for further development.

NIOSH will serve as a co-author on the manuscript in accordance with CDC authorship guidelines.

Quarterly Reports Email Within one (1) week after the end of each quarter

N/A

Final Report Email One (1) month prior to the end of the period of performance

Demonstration – Option B – Tasks to be performed

Means of

Delivery

Due Date Payment

Roster Roster Within 14 days of the effective date of this contract and prior to performing any work on behalf of HHS

N/A

Contractor Employee Non- Disclosure Agreement

(NDA)

Contractor

Employee Non-

Disclosure

Agreement

(NDA)

Prior to performing any work on behalf of HHS

N/A

Privacy Threshold Analysis (PTA)/ Privacy Impact Assessment (PIA)

Assist in the completion of a PTA/PIA form

Within 7 days after contract award

N/A

Training Records Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

N/A

Rules of Behavior Signed ROB for all employees

Initiation of contract and at least annually thereafter

N/A

Background Investigation Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS

N/A

Task Option B0: Develop Project Plan

Email Within six weeks of contract

Task B1: Develop a standard operating procedure to disinfect elastomeric respirators.

Assess and compare different methods of elastomeric disinfection to determine best practices.

Email Within three months of contract award

Task B2: Assess and compare two different methods of elastomeric disinfection to determine best practices. Prepare a report comparing the methods and describing best practices.

Email Within 12 months of contract award

Task B3: Assess the results of knowledge and experiential surveys administered to HCP participants.

Provide a report on the findings of the surveys.

Email Within 14 months of contract award

Task B4: Provide a report of observations by health system leadership about feasibility of elastomeric disinfection before, during, and after the demonstration period.

Email Within 16 months after start

Task B5: Provide a free webinar to the general public presenting the findings described in final report. NIOSH will coordinate the webinar.

Skype/Adobe connects

Within 17 months after start

Task B6: Draft, submit and revise through final journal submission at least one peer-reviewed manuscript for the base and each demonstration project to document the results, lessons learned and considerations for further development. NIOSH will serve as a co-author on the manuscript in accordance with CDC authorship guidelines.

Quarterly Reports Email Within one (1) week after the end of each quarter

N/A

Final Report Email One (1) month prior to the end of the period of performance

(c) Report Approvals

(1) Monthly and Quarterly Reports

The Government shall be allowed fourteen (14) days to review the report and notify the Contractor in writing of approval or of recommended changes to be made in the final copy. If the Government does not approve or recommend changes within fourteen (14) days of receipt of the draft report, the report shall be deemed approved. Within fourteen (14) days of receipt of a notice of approval from the Government of any contract related document, the Contractor shall furnish the Government with 508 compliant Portable Document Format (PDF) file versions of the reports and additionally a reproducible master hard copy of the instructor’s guides in final form.

(2) Journal Publications

The Government shall be allowed thirty (30) days to review the report and notify the Contractor in writing of approval or of recommended changes to be made in the final copy.