Draft NPDB Disputes Resolution SOW_1-3-24.pdf

Draft Statement of Work (SOW)

January 29, 2024

I. PROJECT TITLE

Bureau of Health Workforce (BHW) National Practitioner Data Bank (NPDB) – Disputes Resolution

II. BACKGROUND

The Health Resources and Services Administration (HRSA) is an agency of the United States (U.S.)

Department of Health and Human Services (HHS) whose programs provide health care to people who are geographically isolated and economically or medically vulnerable. HRSA provides leadership and financial support to health care providers in every state and U.S. territory.

The NPDB serves as an alert or flagging system to assist federal and state licensing and certification authorities, hospitals, and other health care entities in evaluating the qualifications of health care practitioners they seek to license, hire, or contract with, or to whom they wish to grant clinical privileges.

The NPDB discloses to eligible entities information on medical malpractice payments, adverse clinical privileges actions, adverse licensure actions, and other adverse actions taken against physicians, dentists, and other health care providers by State licensing authorities, hospitals, and professional societies.

Further, the NPDB was designed to reduce health care fraud and abuse by collecting and disclosing to the authorized entities information on health care-related civil judgments and criminal convictions, adverse licensure and certification actions, exclusions from health care programs, and other adjudicated actions taken against health care practitioners, providers, and suppliers.

III. DISPUTES RESOLUTION OVERVIEW

When the subject of an NPDB report disagrees with the factual accuracy of the report or believes it doesn’t meet the NPDB’s reporting requirements, they can dispute the report. Dispute Resolution is a request for the Secretary of the U.S. Department of Health and Human Services to review the report. The Secretary authorizes HRSA’s Division of Practitioner Data Bank (DPDB) to conduct this review. The Division is responsible for management and oversight of the NPDB.

When a report is entered into Dispute Status by the subject of the report, the NPDB sends a notification of the dispute to the reporting entity and all queriers who received the report within the past 3 years. The notification is included with the report when it is released to future queriers.

Federal regulations strictly limit the NPDB’s jurisdiction for reviewing disputed reports. The review can only focus on the following:

• If the report was submitted in accordance with reporting requirements.

• If the reporting organization was eligible to report the information.

• If the report accurately depicts the action taken by the reporting organization and basis for the action in the organization’s written record.

The practitioner must resolve any other issue with the reporting organization. Requesting Dispute Resolution does not remove a report from the NPDB.

The request for Dispute Resolution includes:

• A written statement describing which facts are in dispute and what the subject believes are the facts;

• Documentation substantiating that the reporting entity’s information is inaccurate. Such documentation shall directly relate to the facts in dispute and substantially contribute to a determination of the factual accuracy of the report and whether it complies with reporting requirements.

• Proof that the subject attempted to resolve the disagreement directly with the reporting entity but was unsuccessful. Proof may be a copy of the subject’s correspondence to the reporting entity and the entity’s response, if any. To give the reporting entity time to respond to the dispute, the subject shall wait for 60 days from the date of initiating discussions with the reporting entity before requesting Dispute Resolution review, unless the reporting entity has indicated earlier that they will not consider a revision.

Documentation may be submitted to the NPDB through secure, electronic upload. Delivery through U.S. mail can also be accommodated.

There are three (3) possible outcomes for the Dispute Resolution review process:

1. The Secretary concludes that the report is accurate as submitted.

2. The Secretary concludes that the report is inaccurate as submitted.

3. The Secretary concludes that the dispute is outside scope of Dispute Resolution.

IV. PURPOSE

The purpose of this contract is to perform analytical tasks related to Dispute Resolution.

V. PERIOD OF PERFORMANCE/PLACE OF PERFORMANCE

The period of performance is a base year of twelve (12) months, and four (4) optional years.

The Contractor shall perform the majority of the work off-site. Three (3) contractors shall be provided with government laptops and workspace at HRSA at 5600 Fishers Lane, Rockville, MD 20857. In-person work shall be directed by the COR.

VI. TYPE

This contract shall be a labor hours award.

VII. TASKS

The contractor shall:

Task 1—Records Management

Task 1.1 - 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.

Task 1.2 - 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?

(http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=36:3.0.10.2.25); 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.

Task 1.3 - 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 course 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, the “Congratulations" slide is considered your certificate of completion.

Please send the completion certificates 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 – Program and Project Management

2.1 Single Point of Contact

Provide a single point of contact for the management of all aspects of this contract to the COR for this call order and to the Program Manager of the investment (PPM). The point of contact shall be responsible for ensuring that the services and deliverables required under this contract are provided to the COR and PPM.

2.2 Meetings

Meet with BHW staff on a regular basis. Federal travel guidance encourages the use of telephone conference calls, video conferences, and web-based meeting (screen-sharing) technology to minimize travel costs. These meetings will be used to discuss the program or project progress. Also, they can be used to address any current and foreseeable issues. Effectively communicate with the NPDB so that overall program and project goals are managed successfully. Required meetings are noted below, and other meetings as directed by the COR. Take meeting minutes and provide to the government within three

(3) days after the meeting. A designated federal product owner will review and approve/ask for changes to the minutes within one (1) week after receipt.

2.2.1 Kickoff Meeting

Meet virtually with the COR, PPM and other HRSA representatives within ten (10) business days of the effective date of the contract (EDOC) to discuss all current activities and the Statement of Work. Two (2) days prior to the kickoff meeting, provide an agenda for the meeting.

At the kickoff meeting, provide an updated team roster of personnel and proposed communication schedule.

The objectives of the kickoff meeting are to:

1. Initiate the communication process between HRSA and the contractor by introducing key project participants and identifying their roles,

2. Ensure the contractor understands the expectations of key stakeholders regarding the scope of work and the effort described in this contract, including task requirements and objectives,

3. Discuss critical aspect of the project management and deliverables, and

4. Review communication expectations and ground rules.

2.2.2 Weekly Meetings with Other NPDB Contractors

Meet weekly with the COR, PPM and other stakeholders and contractors to discuss project updates and critical issues to be resolved. Notify the COR within one (1) business day, if issues arise that prevent the contractor from attending a meeting. Also notify the COR and PPM within three (3) business days of any event which will create a delay in the schedule and/or result in additional cost to HRSA. All notifications shall be submitted electronically to the COR and PPM in writing and shall document the reason for the delay, the status of the budget, the impact on the project, and the action the contractor is taking to bring the project back on schedule.

2.2.3 Biweekly DPDB Policy and Disputes Branch Meetings

2.2.4 Monthly Management Meetings with COR, PPM and DPDB Staff

2.2.5 Monthly DPDB Division Meeting

2.2.6 Technical Meetings

Participate in and facilitate technical meetings, conference calls and/or workgroups with HRSA Program staff and other project stakeholders. Within three (3) business days of the meeting, develop and provide the COR, PPM, Federal Project Manager (Federal PM) and Federal Project Team brief, summarized minutes that identify the attendees, meeting discussion, and all action items.

2.3 Reports

Provide the COR, PPM, and other stakeholders a Monthly Status Report for each monthly reporting period, due on or before the tenth (10th) business day after the end of the reporting period. This report shall contain the following sections:

2.3.1 Monthly Status Report

Provide the COR, PPM, and BHW stakeholders a Monthly Status Report listing the status of all activities, due on or before the tenth (10th) business day after the end of the reporting period. This report shall contain the following sections:

o Details of the resources used, total hours, and total dollars expended at the project level during the reporting period, o Performance Metrics, and o Invoice status.

2.3.2 Final Report

The final report shall be provided to the COR and PPM and include all previously delivered documents, templates and any meeting material or presentation slide decks, as well as any incorporated corrections/clarifications based on comments and questions provided by the government during meetings and presentations. The final deliverable is due no later than ten (10) working days before the end of the period of performance.

Task 3 – Disputes Resolution

The subject of a report may dispute either the factual accuracy of a report or whether a report was submitted in accordance with the NPDB reporting requirements, including the eligibility of the entity to report the information to the NPDB. A subject cannot dispute a report in order to protest a decision made by the reporting entity or to appeal the underlying reasons for the report. If the reporting entity declines to change the disputed report or takes no action, the subject may request that the Secretary of HHS review the disputed report to determine its accuracy and/or whether it complies with reporting requirements.

To initiate the Dispute Resolution process, the subject must do so on-line. All accompanying documentation must be sent to the NPDB Operations Team not directly to the Secretary of HHS. Recent system enhancements encourage report subjects as well as the reporting entities to submit documents on-line; they are also encouraged to limit submitted information to only contain relevant documentation germane to the scope of the review authority delegated by the Secretary. Once the criteria for requesting the report be elevated for Dispute Resolution review is met, the NPDB Operations Team elevates the case to DPDB for review. An overview of the NPDB Disputes Process is provided at https://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp?page=FDisputeProcess.jsp

3.1 Provide three (3) full time equivalents (FTEs) to participate, as requested by the COR, in the Dispute Resolution process and support the NPDB Dispute Resolution review designee (Policy & Disputes Branch Chief). These contractors shall participate in workgroup activities and other DPDB activities on-site as directed by the COR.

3.2 Track and maintain the information used for Dispute Resolution review using the Disputes Tracker module or other case management system within the NPDB. The Dispute Resolution process includes:

3.2.1 Review assigned cases including all documentation from the subject of the report and reporting entity.

https://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp?page=FDisputeProcess.jsp

3.2.2 Request additional supporting documentation from the subject and reporting entity as needed and follow up if necessary, via secure messaging, phone calls, or other allowable mechanisms to obtain the necessary supporting documentation.

3.2.3 Conduct analysis of the record based on NPDB reporting statutes and regulations to determine reportability of the action, accuracy of the report, and eligibility of the reporting entity to submit the report.

3.2.4 Draft the case decision letters and participate in the internal review processes per protocol.

3.2.5 Coordinate submitting the final signed decision letters to all the parties and closing the case, including sending to the reporting entity a request for corrections or voids when applicable.

3.3 Conduct training of the disputes contract staff. Incumbent contractor will train the dispute contract staff as part of the transition period.

Task 4—Security and Privacy Requirements

I. Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

i. 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.

ii. 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.

b. 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:

i. 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.

ii. Categorize all information owned and/or collected/managed on behalf of HHS/HRSA and information systems that store, process, and/or transmit HHS information 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. Based on information provided by the ISSO, CISO, HRSA Senior Official for Privacy (SOP), or other representative, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three

(3) factors of the information or information system are the following:

Confidentiality: [ ] Low [X ] Moderate [ ] High Integrity: [ ] Low [X ] Moderate [ ] High Availability: [ ] Low [ X ] Moderate [ ] High Overall Impact Level: [ ] Low [X ] Moderate [ ] High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of HHS/HRSA regardless of location or purpose.

iv. 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).

v. 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.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. 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:

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

ii. To ensure that the public's personal information is protected in a manner commensurate with the privacy risks, HHS uses a privacy analysis process to assess the risks associated with HHS's collection and maintenance of PII and to ensure information is handled in accordance with applicable legal, regulatory, and policy requirements. PTAs analyze how information is handled in IT systems and electronic information collections and determines if the IT system or electronic information collection collects, disseminates, maintains, or disposes of PII. PIAs are used to assess the privacy risks of IT systems and electronic information collections that collect, disseminate, maintain, or dispose of PII about members of the public. PIAs also provide transparency into how HHS collects, disseminates, maintains, or disposes of the public's PII.

iii. The contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not PII is collected, disseminated, maintained, or disposed as part of the contract. The PTA will determine if a full Privacy Impact Assessment (PIA) needs to be completed. If the results of the PTA show that a full PIA is needed, the contractor must support the agency with completing a PIA for the system or information within 60 days after completion of the PTA and in accordance with HHS policy and OMB M-03-22, Guidance for Implementing the Privacy Provisions of the E-Government Act of 2002.

The contractor must support the agency in reviewing the PIA at least every three (3) years 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.

e. 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:

i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. 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

iv. 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.

f. 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.

g. 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 assumes responsibility for protection of the confidentiality of government records and must ensure that all work performed by its employees and subcontractors must 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 must 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 must be protected in accordance with HHS and HRSA policies. Unauthorized disclosure of information will be subject to the HHS/HRSA sanction policies and/or governed by the following laws and regulations:

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

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

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

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

i. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

j. 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 must 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, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

k. Contract Documentation. The contractor must use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate. See Appendix B for baseline deliverables.

l. Standard for Encryption. The contractor (and/or any subcontractor) must: i. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

ii. 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 encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and HRSA-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).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificate from the NIST CMVP. The contractor must provide a written copy of the validation documentation to the COR.

v. 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 http://csrc.nist.gov/publications/.

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

m. Contractor Non-Disclosure Agreement (NDA). Each contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the HRSA non-disclosure agreement. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or COR prior to performing any work under this acquisition.

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All contractor (and/or any subcontractor) employees assigned to work on this contract and have access to HRSA’s network must complete the applicable HHS/HRSA Cybersecurity Awareness Training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete HHS/HRSA Cybersecurity Awareness Training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. 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 for IT Admin 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.

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

3. Rules of Behavior 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 (included in the HHS/HRSA Cybersecurity Awareness Training), and any applicable system-level rules of behavior.

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 HHS/HRSA Cybersecurity 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.

4. Incident Response The contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/HRSA Computer Security Incident Response Team (hrsacsirt@hrsa.gov) within 24 hours, whether the response is positive or negative. In accordance with FISMA and OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "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" and a privacy breach is "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 any other than authorized purpose." For additional information on the HHS breach response process, please see the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificate from the NIST CMVP.

ii. 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 must send HRSA approved notifications to affected individuals following specific instructions from the HHS Privacy Incident Response Team (PIRT).

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the HRSA Computer Security Incident Response Team (hrsacsirt@hrsa.gov) or 301-443-3333, COR, CO,HRSA SOP (or his or her designee), and other stakeholders, including breaches 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 HRSA 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, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the contractor must:

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

Not include any sensitive information in the subject or body of any reporting e-mail;

and Encrypt sensitive information in attachments to email, media, etc.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS and HRSA privacy breach response policies when handling PII breaches.

v. Provide full access and cooperate on all activities as determined by the government to ensure an effective incident response, including providing all requested images, logfiles, 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.

5. 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:

Non-sensitive T2 moderate risk background investigation.

6.Homeland Security Presidential Directive (HSPD)-12 The contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster The contractor (and/or any subcontractor) must 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 must be submitted to the COR and/or CO within 14 days of the effective date of this contract. Any revisions to the roster as a result of staffing changes must be submitted within 14 days 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 must provide a position description and the government will determine the appropriate suitability level.

8. Contract Initiation and Expiration

a. General Security Requirements. The contractor (and/or any subcontractor) must 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 must follow the HHS EPLC framework and methodology and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, 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.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the contractor (and/or any subcontractor) must provide all required documentation, including HRSA Disposition Plan 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.

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

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must 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 must 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 HRSA policies.

f. The contractor (and/or any subcontractor) must perform and document the actions identified in the HRSA Clearance Form for Separating Employees and Contractors (Form-419) when an employee terminates work under this contract within 14 days of the employee's exit from the contract. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention

a. The contractor (and/or any subcontractor) must 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 Policy for Records Management and HRSA policies and must not dispose of any records unless authorized by HHS/HRSA.

b. In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with HHS/HRSA policies.

10. High Value Asset (HVA) If a system is identified as HVA, the contractor must comply with the HHS Policy for the High Value Asset (HVA) Program and the DHS HVA Control Overlay in addition to the above requirements.

II. Requirements for Procurements Involving Privacy Act Records

Privacy Act It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records about individuals from which records are retrieved by name or other identifying particular.

The System of Records Notice that is applicable to this contract is: (09-15-0054) -https://www.federalregister.gov/documents/2023/03/24/2023-06096/privacy-act-of-1974- system-of-records

The system of records design, development, or operation work the contractor is to perform is: Write technical and security updates, perform content change review, and manage the update process.

The disposition to be made of the Privacy Act records upon completion of contract performance is: This approved disposition schedule is referenced in the SORN and is DAA-0512-2017-0002 -https://www.archives.gov/files/records-mgmt/rcs/schedules/departments/department-of-health-and-human-services/rg-0512/daa-0512-2017-0002_sf115.pdf.

VIII. SCHEDULE OF DELIVERABLES

Section 508 Language for Solicitations and Contracts with Information and Communications Technology (ICT)

The contractor shall ensure all products and services delivered under this contract are compliant with Section 508 in accordance with the Health and Human Services Acquisition Regulation (HHSAR). These Section 508 Standards were issued by the United States Access Board (https://www.access-board.gov/) and published in the Federal Register, on January 18, 2017, as the final rule (https://www.access-board.gov/ict/). The final rule updates the Section 508 Standards along with accessibility guidelines for telecommunication products and equipment covered by section 255 of the Communications Act.

The Section 508 Standards applicable to this contract are:

Section 508 Standards and Guidelines (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines)

• Web Content Accessibility Guidelines (WCAG) 2.0 o Success Criteria, Level A and AA

• Chapter 3: Functional Performance Criteria (FPC)

• Chapter 4: Hardware (If Applicable)

• Chapter 5: Software https://www.archives.gov/files/records-mgmt/rcs/schedules/departments/department-of-health-and-human-services/rg-0512/daa-0512-2017-0002_sf115.pdf https://www.archives.gov/files/records-mgmt/rcs/schedules/departments/department-of-health-and-human-services/rg-0512/daa-0512-2017-0002_sf115.pdf https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

• Chapter 6: Support Documentation and Services

Section 508 requires that all external public facing content and non-public facing official agency communications be accessible. Regardless of format, all digital content or communications materials produced as deliverables under this contract must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

The contractor shall complete and submit the applicable HHS Section 508 Accessibility Compliance Checklist per Section 508 deliverable. The checklist will serve as an artifact declaration of the Section 508 deliverable's compliance. Remediation of any Section 508 deliverables that do not comply with the applicable requirements as set forth below shall be the contractor's responsibility.

HHS guidance and checklists regarding accessibility of documents can be found at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html.

The HHS Section 508 Product Assessment Template (PAT) that is referenced above in 352.239-73 Electronic Information and Technology Accessibility Notice, Paragraph (c), has been replaced with the Voluntary Product Accessibility Template Version (VPAT) 2.4 or later, and is considered to meet HHS PAT requirement. The new form can be downloaded from https://www.itic.org/policy/accessibility/vpat.

NOTE: ICT vs. EIT Procurement documentation from HHS or other agencies may contain references to "EIT" (Electronic and Information Technology) and "ICT" (Information and Communications Technology). HHS considers these terms to be interchangeable, and "EIT" should always be interpreted to be "ICT" in any HHS procurement.

Unless otherwise agreed, Services and/or Deliverables will be reviewed under the following process:

1. Within ten (10) business days of delivery of any Services and/or Deliverables, HRSA will evaluate such Services and/or Deliverables and provide to the contractor written notice of their acceptance or rejection;

2. If the contractor does not receive notice of rejection from HRSA within the expiration of the ten (10) business day review period, the Services and/or Deliverables will be deemed to be accepted by HRSA;

3. HRSA may reject a Services and/or Deliverables if it fails to materially conform to the applicable documented specifications or requirements. Any notice of rejection must indicate the specific basis for the rejection including updates that need to be addressed. The contractor will resolve those items and resubmit the Services and/or Deliverables for approval within an agreed upon and stated time period;

4. The revised Services and/or Deliverables will be deemed accepted if, within 10 business days after the contractor resubmission under Step (c) above, HRSA has not provided to the contractor written notice identifying specifically any basis for not approving the Services and/or Deliverables. HRSA’s review under Step (d) will be limited to those items addressed in the resubmission. The contractor will be entitled to rely on all decisions and approvals of authorized HRSA representatives in connection with the Contract.

All deliverables shall be submitted in Confluence program management tool (508 compliant) presented to the PPM and COR subject to the following schedule:

Item Deliverable Date https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat

Task 1.3 Records Management Training Certificate

Include with first report

Task 2.2 Team Roster At kickoff meeting Task 2.2 Meeting Agendas Two (2) days prior to meeting Task 2.2 Meeting Minutes Three (3) days after the meeting Task 2.3 Monthly Report Tenth (10th) business day after the end of the reporting period Task 2.3 Final Report Ten (10) days prior to the end of the POP Task 3.2 Final decision letter and completed case file Goal of six (6) months from the day the case was assigned but no later than twelve (12) months depending on the circumstances of the case

IX. PERFORMANCE AND QUALITY REQUIREMENTS

Requirement Description Performance Goal Measurement Method

Reporting Frequency

Initial dispute case review

Conduct preliminary review of the assigned case

Within five (5) business days of case assignment

Tracker timeline Per dispute case

Request for information

Send request for information as applicable

Within ten (10) business days of case assignment

Tracker timeline Per dispute case

Case analysis and writing draft decision letter

After comprehensively analyzing the case records, draft the decision letter and send for peer review then for manager review

Within three (3) month goal, 80% of cases

Within five (5) month goal, 90% of cases

Tracker timeline Per dispute case

Peer review or manager review response

Adequately address the feedback on the draft decision letter from the peer reviewer or manager as applicable

Within five (5) business days of receiving the feedback

Tracker timeline Per dispute case

Close dispute case Close the dispute case according to the established process for each type of decision within the six (6)-month goal, 80% of cases within the nine (9) within twelve (12) month goal, 100% of cases

Consolidated Case File

Review and verify the accuracy of the final consolidated case file

Within five (5) business days after the case has been closed

Tracker timeline Per dispute case

Request for correction and void letters

Send the finalized request for correct or void letter and monitor that the appropriate action is taken and follow up as needed until the case is closed

Within two (2) month goal, 80% of cases

Within three (3)

X. PAYMENT SCHEDULE

TBD

XI. REFERENCE MATERIAL

A. Organizational Conflict of Interest (OCI):

1.1 Disclosure Notice:

The contractor may be disqualified from award if it fails to provide, or makes any misrepresentation in connection with, required OCI disclosures.

The contractor shall disclose all OCIs that arise after award.

The government may terminate the agreement for convenience if an OCI arises after award.

The contractor is required to flow down OCI restrictions to its subcontractor.

Misrepresenting or failing to disclose information related to OCIs may result in termination for default, suspension/debarment, and/or other remedies legally available to the government.

1.2 Commitment to Protect Privileged Information Contractor Agreement The following statement is to be completed by all contractor employees who may be involved in the performance of contract work:

Access to privileged information from the NPDB files is required in the performance of my official duties, under contract number (indicate the contract number) between (indicate the DHHS component) and my employer, (indicate your company name).

I, (indicate your name), on this ( ) day of 20( ), hereby agree that I shall not release, publish, or disclose such information to unauthorized personnel, and I shall protect such information in accordance with the provisions of 18 U.S.C. 641, 18 U.S.C. 1905, Public Law 96-511, and other pertinent laws and regulations governing the confidentiality of privileged information.

I understand the provisions of 18 U.S.C. 641, 18 U.S.C. 2071, and Public Law 96-511 and that I am subject to criminal penalties prescribed by law for any violations thereof.

Signed: ___________________________

Date: _____________________________

Witnessed by: _____________________

Date: _____________________________

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