Amendment 1 - Newborn Screening Clearinghouse

Attachment A STATEMENT OF WORK August 21, 2023 Project Title: Content Development for the Newborn Screening Information Center (MCHB62 C 4669) BACKGROUND The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), is the primary federal agency for improving access to health care for the tens of millions of Americans who, for a variety of reasons, are medically underserved or face barriers to needed care. HRSA's mission is to improve health and achieve health equity through access to quality services, a skilled health workforce and innovative programs. Newborn Screening (NBS) is a successful public health program implemented at the state level that saves and/or improves the lives of thousands of babies each year in the United States. Four million newborns each year are screened for conditions that are included on state's NBS panels as recommended by the HHS Secretary. These conditions may not be apparent at birth but require early intervention and treatment. Early detection mitigates brain and organ damage, may attenuate disease severity, and prevent life-threatening complications associated with these conditions. MCHB has administered various NBS and other heritable disorders programs, which were authorized by the Newborn Screening Saves Lives Act of 2007 (P.L. 110-204) and reauthorized by the Newborn Screening Saves Lives Reauthorization Act of 2014 (P.L. 113-240). These programs collectively aim to enhance, improve, or expand the ability of states and local public health agencies to provide screening, counseling, and health care services to newborns and children having or at risk for having heritable disorders. The Maternal and Child Health Bureau of HRSA is providing this contract in support of the Newborn Screening Saves Lives Reauthorization Act of 2015 (Public Health Service Act - 1112 (42 U.S.C. 300b-11)). The statute requires HRSA to establish and maintain a central clearinghouse of current educational and family support and services information, materials, resources, research, and data on NBS. The Newborn Screening Information Center (NBSIC) is a trusted resources for NBS and is an objective, impartial website. The HRSA Office of Communications (OC), within the Office of the Administrator, directs all web and social media outreach efforts of the agency. This includes creating, publishing, managing, deleting, maintaining, and ensuring Section 508 compliance, usability and plain-language writing of the content for www.hrsa.gov and its sub-domains to host content developed through this requirement. The HRSA OC team will be uploading the content to https://newbornscreening.hrsa.gov/ and https://newbornscreening.hrsa.gov/es. The purpose of the NBSIC website is to: Enable parents and family members of newborns, health professionals, industry representatives, and other members of the public to increase their awareness, knowledge and understanding of NBS. Increase awareness, knowledge, and understanding of NBS for expectant individuals and families. Per the legislation, the NBSIC website shall: Be available on the Internet. Include an interactive forum. Be updated on a regular basis, but not less than quarterly. Provide the following: links to Government-sponsored, non-profit, and other Internet websites of laboratories that have demonstrated expertise in NBS that supply research-based information on NBS tests currently available throughout the United States. information about newborn conditions and screening services available in each State from laboratories certified under the Clinical Laboratory Improvement Amendments, including information about supplemental screening that is available but not required, in the State where the infant is born. current research on both treatable and not-yet treatable conditions for which NBS tests are available. the availability of Federal funding for newborn and child screening for heritable disorders including grants authorized under the Newborn Screening Saves Lives Reauthorization Act of 2014; and other relevant information as determined appropriate by the Secretary and HRSA. PURPOSE/GENERAL DESCRIPTION The purpose of this contract is to develop new materials and maintain current educational materials in English and Spanish for a central clearinghouse of NBS information that is located at https://newbornscreening.hrsa.gov/ and https://newbornscreening.hrsa.gov/es. III. PERIOD OF PERFORMANCE / PLACE OF PERFORMANCE The period of performance shall be for one base year and four (4) option years. The place of performance will primarily be at the contractor's facility. Federal Holidays New Year's Day January 1 Martin Luther King's Birthday 3rd Monday in January Washington's Birthday 3rd Monday in February Memorial Day last Monday in May Juneteenth National Independence Day June 19 Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25 Federal law (5 U.S.C. 6103) establishes the public holidays listed in these pages for Federal employees. Please note that most Federal employees work on a Monday through Friday schedule. For these employees, when a holiday falls on a nonwork day -- Saturday or Sunday -- the holiday usually is observed on Monday (if the holiday falls on Sunday) or Friday (if the holiday falls on Saturday). IV. TASKS Task 1 - Records Management Training The Contractor shall: Records and Information Regulation Guidelines: In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. Records and Information Management: The contractor shall manage and maintain Federal records and/or information, including electronic records and/or information, ensuing from this contract in accordance with all applicable records management laws and regulations, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33); 36 CFR - 1236.20 What are appropriate record keeping systems for electronic records? & 1236.22 What are the additional requirements for managing electronic mail records? https://www.ecfr.gov/current/title-36/part-1236; NARA Bulletin 2013-02, August 29, 2013, Guidance on a New Approach to Managing Email Records (https://www.archives.gov/records-mgmt/bulletins/2013/2013-02.html); and NARA Bulletin 2010-05 September 08, 2010 (http://www.archives.gov/records-mgmt/bulletins/2010/2010-05.html), Guidance on Managing Records in Cloud Computing Environments. Managing the records includes, maintaining records to retain functionality and integrity throughout the records' full lifecycle including: (1) maintenance of links between records and metadata, and (2) categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA-approved retention schedules. Records Management Training: The contractor (and/or subcontractor) shall ensure that all employees having access to (1) Federal information or a Federal information system, or (2) personally identifiable information (PII), complete the HHS Records Management Training before performing work under this contract, and thereafter completing the annual refresher training during the life of the contract. The training is located at https://humancapital.learning.hhs.gov/courses/2022recordsmanagement/01_index.html. At the end of the Records Management training, please send the "Certificate of Completion" to the Contracting Officer Representative (COR) of the contract. The listing of completed training shall be included in the first progress report. Any revisions to this listing as a result of staffing changes shall be submitted with next required progress report. Task 2: Kickoff Meeting The Contractor shall: 2.1 Meet with the Contracting Officer's Representative (COR) and other HRSA staff invited by the COR within two (2) weeks of Effective Date of Contract (EDOC) using a web-based meeting platform (such as WebEx or Zoom) to introduce key task participants and their roles in the project, discuss the draft work plan and timeline for all phases of the project, scope of work, schedule of deliverables, priorities, and identify any potential challenges. 2.2 Electronically submit via email a draft meeting agenda and any materials within five (5) business days of EDOC to the COR. The draft agenda and materials will be reviewed by the COR prior to the meeting. 2.3 Take meeting minutes and electronically submit to the COR within three (3) business days after the Kickoff Meeting. The meeting minutes shall reflect any changes to the project timeline and include a list of anticipated deadlines reflecting all agreed upon outcomes of the discussion. 2.4 Revise the meeting minutes as directed by the COR and electronically submit the revised meeting minutes to the COR within two (2) business days after receipt of comments from the COR. Task 3: Project Management Task 3.1 - Monthly Meetings The Contractor Shall: a. Meet with the COR and other members as indicated by the COR monthly using a web-based meeting platform (such as WebEx or Zoom) to discuss the status of contract and other pertinent issues. These meetings shall include the following discussion items: Progress on activities that have occurred since the EDOC or date of last call, including problems encountered and potential future problems, solutions or steps taken to resolve challenges, actual and possible delays in deliverables, etc.; Progress and plans for upcoming activities, for review and acceptance by the COR; Technical direction based on any questions or problems the contractor has to achieve the desired outcomes on the project plan. b. Develop an agenda for the meeting and electronically submit to the COR in Microsoft Outlook for review and acceptance no less than three (3) business days before each meeting. c. Take meeting minutes of each meeting and electronically submit the draft minutes to the COR within two (2) business days of each meeting. The minutes shall include a list of any decisions made during the meeting and action items due by the COR and the Contractor until the next meeting. Task 3.2 - Quarterly Meetings The Contractor Shall: a. Each quarter, conduct quarterly meetings using a web-based meeting platform (such as WebEx or Zoom) with the COR and designated HRSA staff, including management, project officers of other grants related to NBS, the HRSA website team, and other members as indicated by the COR. The meeting will discuss new updates to the NBSIC website since the last quarterly meeting, challenges, and resolutions to complex task assignments, allow for HRSA staff feedback, and follow-up action items. b. Develop an agenda for the meeting and electronically submit to the COR in Microsoft Outlook for review and acceptance no less than three (3) business days before each meeting. c. Take meeting minutes of each meeting and electronically submit the draft minutes to the COR in Microsoft Word within two (2) business days of each meeting. The minutes shall include a list of any decisions made during the meeting and action items due by the COR and the Contractor until the next meeting. Task 3.3 - Quarterly Progress Report The Contractor Shall: Electronically submit a quarterly progress report to the COR outlining activities and issues affecting contract performance. The quarterly report shall be submitted five (5) business days after the end of each quarter. Specifically provide the following in the quarterly progress report: Status of Work - In a narrative and table, highlight the status of activities by task, including any significant events, trends, or problems that occurred along with suggestions for resolution and/or recommendations for improving performance. Planned Activities for Next Three Months - Include a discussion of the work to be performed, by task, during the subsequent month and estimated completion date of each task. Task 4: Work Plan The Contractor Shall: 4.1 Submit a revised work plan that was submitted in the proposal to the COR twenty (20) business days after the kickoff meeting. The revised workplan will refine priorities for inclusion in the work plan; to incorporate HRSA's input; and reflect discussions from the project kickoff meeting. The revised work plan shall include updated objectives and deliverables associated with timelines and milestones. 4.2 The work plan shall be updated annually within one-month after the start of each exercised option period. 4.3 Complete all activities from the technical work plan within five (5) business days before the end of each period of performance. Task 5: Development of Web Content for the NBSIC Websites The Contractor Shall: 5.1 Provide expertise and update content on the following topics related to NBS: newborn and child medical/genetic conditions including presenting phenotype, diagnosis, treatment, genetic etiology and implications for family members; family education; screening practices; laboratories methods; public health impact; information technology; health education; medical home; health literacy; cultural competency and patient/family-centered care experts that have served the needs of diverse populations and stakeholders. 5.2 Content shall be submitted to the COR in the Quarterly Updates of Content for the Newborn Screening Information Center for the following: Update all currently posted pages on the website with updated information. Contact the states on a yearly basis to confirm the information for the state NBS panels. Review quarterly the 56 state and territories website pages to confirm what is on the NBSIC website is the same as the state pages for NBS panels. Provide updated information, as needed, on conditions on the RUSP or other conditions for parents and caregivers. This shall include information on the NBS test, follow up needed to establish a diagnosis, clinical history, management and treatment and services needed by the family. Provide maps or other graphics that show national information on NBS (average of 5 maps of the US and the territories [e.g., number of conditions screened in each state and territory) Provide fact sheets, education tools, infographics, etc. from other groups that are vetted by the contractor (average of 10 items total per year) that will be useful to the stakeholders. Develop emerging NBS and genetics issues summaries (average of 2 pages each year). Develop summaries that highlight challenges faced by parents, caregivers, and other stakeholders in the newborn screening community (average of 5 pages each year) and, if appropriate, solutions or mechanisms to address those challenges. Provide latest NBS technologies information about supplemental screening that is available but not required, in each State (1 page). 5.3 All content must be vetted by NBS experts, as identified by the contractor, and approved by the COR to include that the latest information on the NBSIC website is up to date. 5.4 Incorporate recommendations from HRSA to develop accurate, up-to-date web page content that executes on the findings from the evaluation of the site and the ability to reach the intended audience. The recommendations provided by HRSA are from reviewing the NBSIC website to evaluate the content and the usability of the website. Information will be forthcoming from HRSA of strategies to operationalize the website to maximize its reach and impact. 5.5 Provide one-page summaries, if requested (up to 6 pages per year) and links to: authoritative and/or evidence-based information. community training initiatives. health care provider educational materials. NBS best practices and guidelines. information and tools that promote culturally sensitive education and decision-making regarding NBS for heritable disorders; and quality indicators to measure performance of NBSs, such as false-positive rates and other quality indicators. The draft summary shall be submitted 35 business days after the request need from an email from the COR. The final 508 compliant summary in a PDF document shall be submitted to the COR within ten (10) business days after receipt of comments from COR. 5.6 Coordinate with the HRSA grantees for the Family Engagement and Leadership in Systems of Care, the NBS Excel, NBS Propel, and other HHS grantees as identified by the COR, to identify educational needs. The contractor will not recreate items but will provide emphasis and/or links to established materials. 5.7 Provide links to the COR, quarterly, for websites and other sources of credible information regarding NBS, including Government-sponsored, nonprofit, advocacy, NBS laboratories, and other online websites that have demonstrated expertise in NBS, and that supply research-based information on NBS tests currently available throughout the United States. 5.8 Participate in the steering committees that guide the activities of the project awardee for the Family Engagement and Leadership in Systems of Care and the NBS Excel Program. The COR will provide dates for the steering committees to the Contractor when dates become available. The contractor shall attend two (2) in-person, two-day Steering Committee meeting each year in Washington D.C. 5.9 Vet all non-government websites using the vetting strategy approved by HRSA at the kickoff meeting. See sample guideline https://medlineplus.gov/criteria.html. Also, submit a Quarterly Vetting Report to the COR for all new and revised content at the same time as submitting the Quarterly Updates of Content for the Newborn Screening Information Center. The Vetting Report shall include list of requests for inclusions on the NBSIC website; vetting strategy analysis of each vetting request, and; reason for including/excluding websites. The COR will forward vetting requests from organizations to the contractor. All non-government websites shall be approved by the COR before posting on the NBSIC website. 5.10 Provide current links to the COR, quarterly, to state NBS programs for information including the number of conditions for which each State screens. 5.11 Provide content to the COR, quarterly, for the NBSIC websites on current research on both treatable and not-yet treatable conditions for which NBS tests are available. 5.12 Summarize and provide links to the COR, quarterly, to established evidenced-based guidelines related to diagnosis, counseling and treatment with respect to conditions detected by NBS. 5.13 Coordinate website content, under the guidance of the COR with organizations that work on NBS including: the Advisory Committee on Heritable Disorders in Newborns and Children, HRSA-funded programs such as the NBS Excel, NBS Propel, Family Engagement and Leadership in Systems of Care, Sickle Cell Disease Follow Up programs, the Parent-to-Parent Health Information Centers, the Thalassemia program, Healthy Start Programs, and Maternal, Infant and Early Childhood Home Visiting Programs, Title V Maternal and Child Health (MCH) Block Grant Program, and any other federally funded program as identified by the COR. The COR will provide point of contact information for the organizations with the contractor to ensure that program content is appropriately reflected on the NBSIC websites. The purpose is to ensure complimentary and not duplicative information. 5.14 Research information about the availability of Federal funding for newborn and child screening authorized under the Newborn Screening Save Live Reauthorization Act of 2014 for inclusion on the NBSICwebsite. 5.15 Provide up to five (5) graphic designs, including digital assets for use in print materials, HRSA's webpages, social media channel, to the COR, within six (6) months of each contract year. Also, provide graphics elements in .gif, .png or .jpg as appropriate for web, as well as the original source file in .ai or other HRSA-approved software. HRSA will provide a style guide. See an additional sample of another HRSA webpage at https://poisonhelp.hrsa.gov/ 5.16 Analyze the website analytics every three months and provide recommendations to the COR on updates and improvements electronically submitted via Microsoft Word. Access will be coordinated by the COR. 5.17 Search Engine Optimization (SEO) Optimize new and existing pages, content, and metadata for external search performance for NBS-related keywords and phrases every three months. Ensure page headers, title, keywords, other metadata, and URL path accurately reflect page content. Ensure content is optimally structured for findability. Make adjustments and changes as needed to ensure findability of NBS content. Task 6: Quarterly Updates of Content for the Newborn Screening Information Center Websites The Contractor Shall: 6.1 Update the website content in English and Spanish quarterly to keep materials current and accurate. Also, submit updated content to the COR by December 1st, March 1st, June 1st, and September 1st of each contract period. 6.2 The Spanish NBSIC content shall be customized to the needs of Spanish-speaking communities - not simply a direct translation of the English website. To ensure an accurate and comprehensive review, Spanish quarterly updates will be completed in sequence to the English quarterly reviews. Spanish reviews will be completed one (1) quarter after an English quarterly review is completed, to ensure that the Spanish review is applied to the most up-to-date English content (i.e., English review completed December 1st, will have a Spanish quarterly review completed by March 1st). Take 7: Promote the NBSIC website The Contractor Shall: 7.1. Create and promote a workplan for the NBSIC websites to promote to other Federal agencies, state and territories websites, and other groups as appropriate and approved by the COR. For Base period Electronically submit to the COR a draft promotion workplan in Microsoft Word within nine (9) months of EDOC. Electronically submit the final submit workplan to the COR in Microsoft Word within one (1) week receipt of comments from COR. For Option Periods 01 through 04 Electronically submit to the COR an updated draft promotion plan in Microsoft Word within one (1) month of EDOC. Electronically submit to the COR the updated final plan to the COR in Microsoft Word within one (1) week receipt of comments from COR. 7.2 Submit abstracts and/or posters to at least 3 conferences (Association of Public Health Laboratories NBS Symposium, American Public Health Association annual meeting, and others as identified and approved by the COR). 7.3 For Option Periods 01 through 04, provide an exhibiting presence at the APHL NBS Symposium, and/or other national meetings promoting the NBSIC website as an educational tool and resource for multiple audiences including the public, providers, public health agencies, and others. Task 8 - Use of Plain Language Guidelines and Other Government Laws and Regulations for all Products The Contractor shall: 8.1 Follow the federal Plain Language Guidelines when developing products. The Plain Language Act of 2010 requires federal agencies to create communications that are clear and understandable to the public. 8.2 Produce content that follows federal plain language guidelines. All text content must aim for a Flesch-Kinkaid Reading Ease score of at least 60. HRSA's Office of Communications liaisons use Readable to review, update, and score content. Contractor shall work with the COR and program communications liaisons and use Readable to review, score and enhance the content. 8.3 Use PlainLanguage.gov's Checklist for Plain Language and HHS's Plain Writing Checklist as guidelines. 8.4 Ensure that all materials adhere to federal copyright laws including the citation of sources in endnotes or footnotes, obtaining written permission to reproduce, reprint, or adapt existing materials used in the creation of materials under this contract; and including credits for images, which include photographs, pictures, illustrations, tables, charts, figures, and graphs. 8.5 Ensure that all materials adhere to the Government Printing and Binding Regulations, including the prohibition on commercial advertising which says, - No Government publication or other Government printed matter, prepared, or produced with either appropriated or nonappropriated funds or identified with an activity of the Government, shall contain any advertisement inserted by or for any private individual, firm, or corporation; or contain material which implies in any manner that the Government endorses or favors any specific commercial product, commodity, or service. -- (Title III--General Provisions, 13. Advertisements, Commercial.) 8.6 Ensure that all materials do not contain any non-federal logos (since logos are a form of institutional advertising); that materials do not contain contact information for non- federal organizations, except the website address for informational purposes; and that all materials do not contain any contact information for individuals. 8.7 Ensure that all materials do not contain the name of the contractor or subcontractors since this is also a form of advertising. 8.8 Ensure that all materials adhere to the prohibition against referring to lobbying in materials produced with appropriated funds. The prohibition against lobbying also includes grassroots lobbying, which is advocating for a change in legislation at the federal, state, or community level. Task 9: HHS Policy for Information Technology Procurements - Security and Privacy Language Procurements Requiring Information Security and/or Physical Access Security Baseline Security Requirements Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following: Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information. 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. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with HHS/HRSA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must: Protect the: 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. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s). Adopt and implement all applicable policies, procedures, controls, and standards required by the HHS/HRSA 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 all applicable security and privacy policies by contacting the CO/COR or HHS/HRSA security and/or privacy officials. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable HHS/OpDiv privacy policies, and complete all the requirements below: Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (PII), is "information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual." Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother's maiden name, biometric records, etc. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be: Marked appropriately. Disclosed to authorized personnel on a Need-To-Know basis. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for 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 Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the NIST CMVP. 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 as...